YaSan_Thesis Report

An Innovative Device for Stroke Patient Home Therapy and Rehabilitation by

Ya-San Fong Committee Chair: Kelly Umstead Committee Member: Bryan LaďŹƒtte

A thesis submitted in partial fulďŹ llment of the requirements for the degree of Master of Industrial Design Department of Graphic and Industrial Design NC State University May 2017

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TABLE OF CONTENTS ABSTRACT………………………………………………………………………………………..………………………….8 ACKNOWLEDGEMENT…………..………………………………………………..………………………….9 1. INTRODUCTION…………..…………………………………………………………………………………10 1.1 What is Stroke?

1.2 Stroke in Younger People 1.3 Stroke Prevention 1.4 After Having a Stroke

1.5

1.4.1

Post-stroke Rehabilitation

1.4.2

The Place of Rehabilitation

1.4.3

Stroke Exercises and Handouts

1.4.4

Stroke Assessment Plan

Summary

2 RESEARCH…………..……………………………………………………………………………………………...23 2.1 Business Situation Analysis 2.1.1

Home Rehabilitation Equipment

2.1.2

Innovation in Rehabilitation

2.1.3

Market Opportunity

2.1.4

Industry Factors

2.1.5

Competitor Analysis

2.1.6

Positioning Strategy

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2.2

2.3

2.4

Customer Analysis 2.2.1

Preparing for Observation

2.2.2

Voice of Customers

2.2.3

Findings

Key Product Technical Specifications 2.3.1

Patent Search

2.3.2

Key Components Definition

Design Goal

3 CONCEPT……………..……………………………………………………………………………………….........51 3.1 User Scenario and Narrative 3.2 Functional Study 3.3 Stroke Wrist Support Product Analysis 3.4 Expected Use Product Workflow 4 DESIGN DEVELOPMENT………………………………………………………………….………….63 4.1 Design Criteria 4.2 Wearable Device Concepts Development 4.2.1 Sketch Ideation 4.2.2 Full-scale Prototyping 4.2.3 Users Testing and Feedback

4.3 App Platform Definition 4.3.1 Brand Development 4.3.2 Workflow of CT App

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5 FINAL DESIGN……………………………………………………………………………….…………….…...79 5.1 CT Device 5.1.1 CMF and Detail Definition 5.1.2 Working Prototyping

5.2 Applications 5.2.1 CT Device/App Simulation 5.2.2 Users Testing and Feedback

5.3 Further Development 6 CONCLUSION………………………………………………………………………………………………….….92 6.1 Final Thought REFERENCE……………………………………………………………………………………..………………………….95

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TABLE OF ILLUSTRATIONS Fig.1.1 Stroke statistics Fig.1.2 Types of stroke Fig.1.3 Troy Hodge was a stroke patient who only 41 years old. "You don't think of things you can't do until you can't do them."

Fig.1.4 The National Stroke Association has developed the acronym FAST Fig.1.5 Two usual techniques employed to rehabilitate and recover motor skills: 1. Body weight supported treadmill. 2. Working on balance and strength exercises Fig.1.6 Hand and finger exercises handout Fig. 1.7 Stroke assessment plan Fig. 1.8 The International Classification of Function (ICF) Fig. 1.9 Stroke evaluation by paper recording

Fig. 2.1 Stroke home rehabilitation equipment Fig. 2.2 Robotic instrumentation Fig. 2.3 Force platforms Fig. 2.4 Motion capture Fig. 2.5 Videogame based rehabilitation systems Fig. 2.6 Perceptual map: Price vs. Usability Fig. 2.7 Smart wearable unit sales by device category, developed markets, 2012–2020 Fig. 2.8 Adapted from Mintel market research report: wearables technology prediction Fig.2.9 SWOT analysis Fig. 2.10 The features of wearable devices (highlighting features for stroke patient needs) Fig. 2.11 Perceptual map: Price vs. Quality Fig. 2.12 Perceptual map: Price vs. Features Fig. 2.13 Conversation with occupational therapist at “Steps for Recovery” Fig. 2.14 Customer characteristics for interviews and surveys -5-

Fig. 2.15 Therapist demonstrates problematic body parts Fig. 2.16 Therapist guides the correct posture Fig. 2.17 “Myomo” (EMG robot) which is bulky and mechanical Fig. 2.18 Therapist measures the range of motion manually Fig. 2.19 Multiple buckles with SAEBO stretch glove Fig. 2.20 The issue of static splint Fig. 2.21 Pie chart for survey results Fig. 2.22 Technical analysis via problem finding and customer needs Fig. 2.23 Expected use scenario

Fig. 3.1 User scenario boards for stroke patients and therapists Fig. 3.2 Functional study survey Fig. 3.3 Upper extremity exercise for stroke patients (selected by therapists) Fig. 3.4 Spastic/affected hand post stroke Fig. 3.5 Static splint for stroke hand support Fig. 3.6 Fingerboard wearing process with pain points Fig. 3.7 Wireframe for product expected use

Fig. 4.1 Wearable device sketch ideation Fig. 4.2 Wearable device design directions Fig. 4.3 Wearable device prototype testing (Paper prototypes to evaluate product size and form) Fig. 4.4 Wearable device full-scale prototype for three design directions Fig. 4.5 Users testing and feedback for wearable device prototype Fig. 4.6 Concept selection for three design directions Fig. 4.7 Three potential designs for Direction A Fig. 4.8 Brand logo exploration (Chose “Circular Therapy” as brand name) Fig. 4.9 CT app design (Workflow & Iteration) -6-

Fig. 4.10 CT app design (“connect device” session) Fig. 4.11 CT app design (“exercise” session) Fig. 4.12 CT app design (“progress” session) Fig. 4.13 CT app design (“notification” session)

Fig. 5.1 CT Device (Including wearable device, posture sensor and upper arm sensor) Fig. 5.2 Wearable Device: Functional Details Fig. 5.3 Wearable Device: Materials Fig. 5.4 Posture Sensor and Upper Arm Sensor: Functional Details Fig. 5.5 Wearable device working prototype testing Fig. 5.6 CT sensor working prototype testing (Upper arm and posture sensors) Fig. 5.7 CT sensor wearing process Fig. 5.8 Wearable device in use Fig. 5.9 Removable pocket for cane exercises Fig. 5.10 CT Device indicators Fig. 5.11 Mobile Platform: CT App Fig. 5.12 User testing and feedback for working prototype Fig. 5.13 Treatment program with CT Device Fig. 5.14 Further development

Fig. 6.1 CT Device and CT App

Table. 2.1 Patent search for range of motion Table. 2.2 Patent search for motion tracking and other related technologies

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ABSTRACT Physical therapy exercises are often assigned for stroke patients to complete aspects of their treatment at home. Sometimes results are ineffective due to non-compliance, lack of awareness of body position or improper routines being performed. Physical therapists need a way to track patient activity and monitor progress. This project aims to develop an innovative device which will assist their treatment plans in success.

Keywords: Stroke rehabilitation, Clinical trials, Robotics, Neuroplasticity, Functional outcomes, Physical therapy, Biofeedback, Prevention, Home therapy, Assessment, Range-of-motion, Stretch, Strength, Handout, Instruction

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ACKNOWLEDGEMENT I would like to thank, first and foremost, my thesis advisor Kelly Umstead of the Industrial Design Department at NC State University. The door to Professor Umstead’s office was always open whenever I ran into a trouble spot or had a question about my research or writing. She consistently allowed this paper to be my own work, but lead me in the right direction whenever she thought I needed it.

I would also like to thank all of the experts and patients who were involved in the survey, interview, and observation. They shared their experiences and expertise for this research project: Katie Stephens, Kristin Nuckols, Betsy Shah, Carol, David at STEPS for Recovery, Dr. Chih-Shih Fong, Vicky Yeh and Peter Huang. Without their passionate participation and input, this project could not have been successfully conducted.

I would also like to acknowledge Professor Tsai Lu Liu and Professor Bryan Laffitte of NC State University as members of this thesis committee, and I am grateful to them for their very valuable comments on this thesis.

Finally, I must express my very profound gratitude to my parents, friends and classmates for providing me with unfailing support and continuous encouragement throughout the course of my academic career at NC State University. This accomplishment would not have been possible without them. Thank you.

Author

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1 INTRODUCTION 1.1 1.2 1.3 1.4

1.5

What is Stroke?

Stroke in Younger People Stroke Prevention After Having a Stroke 1.4.1

Post-stroke Rehabilitation

1.4.2

The Place of Rehabilitation

1.4.3

Stroke Exercises and Handouts

1.4.4

Stroke Assessment Plan

Summary

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INTRODUCTION

INTRODUCTION 1.1 What is Stroke?

About 800,000 people in the United States have a stroke each year. Stroke is the third leading cause of death in the United States with more than 140,000 people dying each year. On average, someone in the United States has a stroke every 40 seconds. Total cost of care in first 30 days of stroke is approximately $13,000 in mild cases, and up to $20,000 in severe. Lifetime cost of care for stroke is approximately $140,000(Levine et al., 2007).

It is a tremendous burden for people suffer a stroke as well as their family.

There are two different kinds of stroke: ischemic and hemorrhagic. Ischemic is a blockage of blood vessels which causes a lack of blood flow to the affected area. Hemorrhagic which is a rupture of blood vessels which causes a leakage of blood to the affect area. Basically brain cells die and damage occurs.

Fig.1.1 Stroke statistics

Fig.1.2 Types of stroke

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INTRODUCTION

1.2 Stroke in Younger People In the past, nearly three-quarters of all strokes occur in people over the age of 65. In these few decades, the overall rate of stroke is decreasing. It is increasing for young and middle-aged people, those between 20 and 54 years of age, as identified by the journal Neurology which examined stroke trends in the Greater Cincinnati area (Russell Hardin, 2014). They found that the men age of stroke decreased from 71 years to 69 years, and the rate of stroke in the 20 to 54 age range increased from about 13% to 19%.

Fig.1.3 Troy Hodge was a stroke patient who only 41 years old. "You don't think of things you can't do until you can't do them.�

(Source: http://www.npr.org/sections/health-

Obesity in children and teens is up in America shots/2016/02/18/467222400/strokes-on-theand that increases the lifetime risk for stroke. rise-among-younger-adults) Obesity also increases the risk for high blood pressure, high cholesterol, and diabetes. These are all important stroke risk factors at any age. Although one of the big differences between old age stroke and stroke in young age is recovery, there is a 25 - 40% risk of stroke recurrence during the first five years after a stroke (B. H. Dobkin, 2005). This is a critical issue that needs attention. However, regardless of the reason a stroke occurred, or if the demographic is young or older people, the stroke patients are doing the same rehabilitation treatment.

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INTRODUCTION

1.3 Stroke Prevention According to the Harvard Health Publications, January 2016, there are 6-point plan for stroke prevention.

1. Keep your blood pressure under control. The ideal for healthy adults is 120/80 millimeters of mercury. If you have high blood pressure, work with your doctor to reach your treatment goal.

2. Exercise moderately for at least 150 minutes a week (ideally 30 minutes a day, five days per week). Leisure activities and chores count, too.

3. Eat nutritious plant-based diet. You can include occasional learn red meat, fish at least two times a week, and skinless poultry.

4. Keep your cholesterol within norms.

Take a cholesterol-lowing statin drug if your doctor recommends it.

5. Don't consume more than two standard alcoholic drinks per day. A standard drink is 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80-proof liquor.

6. Don't smoke-or quit if you do.

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Fig.1.4 The National Stroke Association has developed the acronym FAST

INTRODUCTION

1.4 After Having a Stroke 1.4.1 Post-stroke Rehabilitation Stroke rehabilitation is an important part of recovery after a stroke (B. Dobkin & Dorsch, 2013). Especially for the younger stroke population because according to the article’s findings, the survival of the younger stroke population is over 90% at 5 years compared to 40% for older age stroke. Ninety percent are able to live independently compared to about 40% of old age stroke; 50% to 70% are able to return to work after stroke, and 5 year stroke recurrence rates are 50% less than old age stroke.

The goals of rehabilitation are to help survivors become as independent as possible and to attain the best possible quality of life. Rehabilitation helps stroke survivors relearn skills that are lost when part of the brain is damaged. Even though rehabilitation does not "cure" the effects of stroke in that it does not reverse brain damage, rehabilitation can substantially help people achieve the best possible long-term outcome (National Institute of Neurological Disorders and Stroke, 2015).

The length of each stroke rehabilitation therapy session varies depending on patients’ recovery, severity of patients’ symptoms and responsiveness to therapy. Most need some form of stroke rehabilitation long term, possibly months or years after the stroke (Page, Levine, Sisto, Bond, & Johnston, 2002).

There are eight medical professionals specialize in post-stroke rehabilitation (Page et al., 2002), physicians manage long-term care, rehabilitation nurses, physical therapists, occupational therapists, recreational therapists, speech-language pathologists, vocational therapists and mental health professionals. However, physical therapy is a treatment which could see the great improvement for patients and it’s the easier way that they could practice independently as well.

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INTRODUCTION Physical therapists focus on musclular therapy. They assess a survivor's strength, endurance, range-of-motion, gait abnormalities, and sensory deficits to design individualized rehabilitation programs aimed at regaining control over motor functions.

They help survivors regain use of stroke-impaired limbs, teach how to compensate for reduced abilities, and devise exercise programs to help retain new skills (Cuny & Tenette, 1969).

In addition, physical activities and technology-assisted physical activities are involved in a physical therapy session. The training skill in physical activities are including strengthening motor skills, mobility training, constraint-induced therapy and range-ofmotion therapy. Upper extremity exercises are typically prescribed for stroke patients (B. H. Dobkin, 2005).

Fig.1.5 Two usual techniques employed to rehabilitate and recover motor skills: 1. Body weight supported treadmill. 2. Working on balance and strength exercises (Source: http://uctclinic.com/post-stroke-condition)

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INTRODUCTION

1.4.2 The Place of Rehabilitation At the time of discharge from the hospital, the stroke patient and family coordinate with hospital social workers to locate a suitable living arrangement. Many stroke survivors return home, but some move into a specialized medical facility which include inpatient rehabilitation units, outpatient units, nursing facilities and home-based rehabilitation programs (National Institute of Neurological Disorders and Stroke, 2015).

Home rehabilitation allows for great flexibility so that patients can tailor their program of rehabilitation and follow individual schedules. Stroke survivors may participate in an intensive level of therapy several hours per week or follow a less demanding regimen.

These arrangements are often best suited for people who require treatment by only one type of rehabilitation therapist. For example, hands or legs are the most common affected areas. The major disadvantage of home-based rehabilitation programs is the lack of specialized equipment and instructions. However, undergoing treatment at home gives people the advantage of practicing skills and developing compensatory strategies in the context of their own living environment. In the recent stroke rehabilitation trial, intensive balance and strength rehabilitation in the home was equivalent to treadmill training at a rehabilitation facility in improving walking.

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INTRODUCTION

1.4.3 Stroke Exercises and Handouts According to “Hope, a stroke recovery guide� which is a report from National Stroke Association, many stroke survivors have trouble moving around. These problems range from balance issues to arm or leg paralysis. As a result, about 40 percent of stroke survivors have serious falls within a year of their strokes. But, rehabilitation and therapy may improve their balance and ability to move.

The most common physical effect of stroke is muscle weakness and having less control of an affected arm or leg. Survivors often work with therapists to restore strength and control through exercise programs. They also learn skills to deal with the loss of certain body movements.

Paralysis is the inability of muscle or group of muscles to move on their own. After stroke, signals from the brain to the muscles often don’t work right. This is due to stroke damage to the brain. This damage can cause an arm or leg to become paralyzed and/or to develop spasticity.

Spasticity is a condition where muscles are stiff and resist being stretched. It can be found throughout the body but may be most common in the arms, fingers or legs. Depending on where it occurs, it can result in an arm being pressed against the chest, a stiff knee or a pointed foot that interferes with walking. It can also be accompanied by painful muscle spasms.

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INTRODUCTION Treatment Options for Spasticity: - Treatment for spasticity is often a combination of therapy and medicine. Therapy can include range-of-motion exercises, gentle stretching, and splinting or casting.

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Medicine can treat the general effects of spasticity and act on multiple muscle groups in the body.

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Injections of botulinum toxin can prevent the release of chemicals that cause muscle contraction.

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One form of treatment involves the delivery of a drug directly into the spinal fluid using a surgically placed pump.

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Surgery is the last option to treat spasticity. It can be done on the brain or the muscles and joints. Surgery may block pain and restore some movement.

Therefore, walking, bending and stretching are forms of exercise that can help strengthen stroke patients’ body and keep it flexible. Mild exercise, which should be undertaken every day, can take the form of a short walk or a simple activity like sweeping the floor.

Stretching exercises, such as extending the arms or bending the torso, should be done regularly. Moving weakened or paralyzed body parts can be done while seated or lying down.

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INTRODUCTION All of the exercises may be performed alone if patients are able to do so safely. However, for many stroke survivors, it is advisable for someone to stand nearby while an exercise session is in progress. Their caregiver should watch for errors in judgment that could affect safety. For instance, some stroke survivors are not aware that their balance is unsteady, nor can they tell left from right. Others may have lost the ability to read the exercise instructions, or may need assistance to remember a full sequence of movements.

Currently, therapists and physicians are used to selecting the specific exercises that will benefit patients, and who will provide hard copy instructions/handouts for both stroke patients and their caregiver. However, the biggest issue is that the handouts are too hard to read and do not help with proper form. On the other hand, like other rehabilitation exercises, stroke patients will have good and bad days. Therapists need to modify their programs to accommodate for fatigue or other conditions. Avoid overexertion and pain. However, some discomfort may be necessary to make progress, but physical handouts could not tell patients when they need to stop or keep working.

Fig.1.6 Hand and finger exercises handout (Source: http://www.strokewise.info/)

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INTRODUCTION

1.4.4 Stroke Assessment Plan There are different ways of evaluating clinical conditions and interventions. Interviews and observation / clinical observation are two important methods (Domholdt 2000).

Testing / measuring function is another method. Ideally, the assessment process involves all three; an interview, where the patient's perceptions of the main problems are at focus, observations of performance, and tests of performance followed by a process of interpreting the information into goals, a treatment plan and continuously evaluate outcome throughout the intervention process (Wade 1992).

Interview

Observation

Tests of function: body structure / body function, activity, participation

Short and long term goals

Plan of treatment

Fig. 1.7 Stroke assessment plan.

The International Classification of Function (ICF) developed by the World Health Organization (WHO) can be helpful in organizing outcomes and tests. The ICF is divided into body structures and function, activity and participation. Function and disability are umbrella terms within the ICF and used to refer to capacity or performance in all domains whereas disability refers

Fig. 1.8 The International Classification of Function (ICF) (Source: http://www.who.int/en/)

to restrictions; impairments, activity limitations and participations restrictions. In addition, contextual factors like environmental and personal factors can be taken into account. International classification of function can be used to classify measurements in relation to body structures/ functions, activities and participation. The measurements / tests can furthermore be categorized as functional, relating to what the person can do, or as disability, relating to what the person cannot do. The ICF model has no hierarchical direction but can be used and understood in any direction (World Health Organization 2007).

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INTRODUCTION Over the years several tests have been developed for stroke rehabilitation, some generic and some specific (Hill et al. 2005, Finch et al. 2002). The most common tests evaluating persons with stroke are Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA), Rivermead Motor Assessment (RMA) and Stroke Rehabilitation Assessment of Fig. 1.9 Stroke evaluation by paper recording Movement (STREAM). It is obvious that (Source: https://www.tgh.org/stroke-evaluation) most tests reflect impairments, disabilities and restrictions in participation- it is a summary of what the person cannot do. This is slightly opposed to the intentions with the model International Classification of Function which aimed at inspiring to the positive, healthy aspect of function and to focus on what the person with stroke can do. There are few tests reflecting participation, both regarding generic and specific tests.

Tests can be performance based, that is in order to get a score the person has to perform an action. Or tests can be self-reports; that is the person is interviewed or answer a questionnaire about different aspects of disablement (Domholdt 2000). Tests regarding body function / body structures are mainly performance based whereas tests regarding activity and participation often are self-reports.

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INTRODUCTION

1.5 Summary According to the above literature review, the biggest obstacles in the stroke recovery process are patients’ compliance and doing exercises properly at home. In other words, the most crucial issues are: ‣

Patients are less self-aware and it is difficult to observe themselves while performing the action.

‣ Some patients tend to push themselves too hard. ‣ Handouts are confusing and do not help with proper form. ‣ It’s hard for patients to remember a full sequence of movements ‣ If patients don’t think that they are improving, they will give up.

In comparison to healthy population, stroke patients really need to know when their muscle fatigues and it becomes dangerous to continue exercise at home.

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2 RESEARCH 2.1 Business Situation Analysis 2.1.1

Home Rehabilitation Equipment

2.1.2

Innovation in Rehabilitation

2.1.3

Market Opportunity

2.1.4

Industry Factors

2.1.5

Competitor Analysis

2.1.6

Positioning Strategy

2.2 Customer Analysis 2.2.1

Preparing for Observation

2.2.2

Voice of Customers

2.2.3

Findings

2.3 Key Product Technical Specifications 2.3.1

Patent Search

2.3.2

Key Components Definition

2.4 Design Goal

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RESEARCH

RESEARCH 2.1 Business Situation Analysis 2.1.1 Home Rehabilitation Equipment It is well supported that continued strength and flexibility training is essential to improved health for stroke patients. Simple exercise equipment could facilitate therapists treating patients easier as well as have a good encouragement for patients to do the exercise at home.

There are various types of home rehabilitation equipment for stroke patients, such as the pedal exerciser which can be put on a table to train hands and arms or put on the floor to exercise the legs, hand exercisers and putty are used for finger and grip strength training, balance board and large exercise balls are used for balance training, elastic bands for flexibility training, tubing, dumbbells and ankle/wrist weights, for coordination and hand exercises and finally pegs, lacing beads, bean bags, clothespins or Chinese balls, and an arm skate can assist arm range of motion.

Besides the home rehabilitation equipment mentioned above, one can also use simple items around the house for therapy exercises. An example of an item a patient may already have that can be used for stroke rehabilitation is balls (i.e. soccer, basketball), which can be used for weight bearing to the weak hand, rolling with the weak hand, bilateral activities such as lifting the ball, or coordination activities such as catching, throwing, or kicking the ball. Household tools (i.e. nuts and bolts, screwdriver) can be used to work on fine motor coordination for the stroke patient that has hand movement but lacks quality of movement.

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RESEARCH Traditional rehabilitation equipment is focused on specific part of body and function.

Stroke patients need to buy separate equipment when they are doing different treatment sessions during different steps. Also, from physical therapists’ point of view, it’s hard to track the status of patients when they are doing exercise at home.

Fig. 2.1 Stroke home rehabilitation equipment (Source: http://www.stroke-rehab.com/home-exercise-equipment.html)

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RESEARCH

2.1.2 Innovation in Rehabilitation Sensors, cameras, robots, smart treadmills and intelligent software: these are only some of the innovative technologies that in the last years have entered into hospitals, clinics and centers dealing with rehabilitation and physical rehabilitation. It is very interesting to understand how this is effects a very traditional world, one where clinicians and physical therapists have always treated patients in a traditional way, i.e. counting on their experience and their "magic hands".

Nevertheless, it is a matter of fact that now technology is really entering into this world, and the most advanced clinics and hospitals in the world have started embracing the innovation, rather than opposing it with the famous statement "we have always done it this way... why we should change?" “Corehab� is certainly one of the players of this ongoing revolution, but there are technologies and systems currently on the market that are really changing the mindset of the traditional world of rehabilitation and physical therapy.

First, robotic instrumentation, when treating hemiplegic, paraplegic or even quadriplegic patients it is sometimes a matter of mobilizing the limb rather than the whole body in order to provide muscle relief and eventually try to recover some of the lost movement patterns.

Such movements are usually very repetitive, and that's where a robot can really provide a valid alternative to a traditional physiotherapist, Fig. 2.2 Robotic instrumentation allowing for time saving and increased efficiency. Rehabilitation robotics has improved in order to make those patients walk again with a total slinging, and this can be done also in front of a virtual reality software. Often robotic technologies attempt to leverage the principles of neuroplasticity by improving quality of movement, and increasing the intensity and repetition of the task.

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RESEARCH Second, force platforms, are included in that family of devices able to detect the force of a patient with sensors, with particular attention to the Center of Pressure (COP) evaluation to understand eventual unbalancing and asymmetries.

Technically speaking, we can classify force platforms as singlepedestal or multi-pedestal by the transducer (force and moment transducer) type. For studies of movements, such as gait analysis, force platforms with at least three pedestals and usually four are used to permit forces that migrate across the plate. Force platforms should be distinguished from pressure measuring systems that, although they too quantify center of Fig. 2.3 Force platforms pressure, do not directly measure the applied force vector.

Pressure measuring plates are useful for quantifying the pressure patterns under a foot over time but cannot quantify horizontal or shear components of the applied forces.

Third, motion capture, is typically used to analyze the detailed movement of an injured patient or a patient following a post-surgery process. Such systems are very popular in gait analysis labs and clinics to assess patients or evaluate an athlete's gesture.

Fig. 2.4 Motion capture

Lastly, video game based rehabilitation, the use of virtual feedback in rehabilitation has been seen scattered throughout history for quite some time. However, though the feedback was virtual, the performances were not widely virtual until the 1990s. As virtual reality systems and virtual environments became more accessible and affordable, though, so too did the implementations of and research on them. The use of these systems in positive motor skill development began somewhere in the late 1990s as more researchers realized the benefit of internal, corrective feedback in such environments. There are some of the main products on the market that really bring videogames as a form of biofeedback or virtual rehabilitation:

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RESEARCH 1. “Rejoyce” by Rehabtronics, a tele-medicine instrument for hand and arm rehabilitation for people with movement impairments.

2. “Hocoma Valedo”, a product of Hocoma, with two distinct sub-products; it enhances the low back pain therapy with functional motivating.

3. “E-Link” by Biometrics, a comprehensive range of products for a computer based standardized evaluation of the Upper and Lower Extremities with progress reporting over time using scientifically collected data which may also be exported for statistical analysis.

4. “Hand Tutor, Arm Tutor, Leg Tutor and 3D Tutor” by Meditouch, ergonomic devices, supplied with dedicated clinical physical therapy software to allow patients with upper and/or lower extremity movement dysfunction to practice intensive physical therapy of single and multi-joints.

5. “Amadeo” by Tyromotion, a mechatronic rehabilitation device in the field of robotic neurorehabilitation. It is used in the rehabilitation of patients exhibiting motor dysfunctions of the distal upper extremity.

Fig. 2.5 Videogame based rehabilitation systems

However, those systems and devices are not suitable for home rehabilitation because they need a professional to operate. Also, they are much more expensive than the traditional equipment. There’s no way for the patients to buy them at home individually.

Therefore, there’s an opportunity in the smart clothing and wearable technology market because it is relatively new in terms of commercialization. Also, the market is growing as a result of the technology becoming more mature and increased consumer adoption.

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RESEARCH

2.1.3 Market Opportunity Traditional home rehabilitation equipment and innovative equipment has been compared using a perceptual map which is based on usability and cost analysis. This map reveals that there is a significant opportunity in the market to design a wearable device for stroke patients to do the home rehabilitation exercises. Therefore, the following research, including SWOT analysis and competitor analysis are focused on wearable device marketplace.

Fig. 2.6 Perceptual map: Price vs. Usability

There are a number of players in the smart clothing and wearable technology market, for some companies, their core business is focused on smart clothing, and for others, smart clothing is merely an extension from a broader product category (McCann & Bryson, 2009).

Today, there is increasing concern among consumers for self-awareness and personal wellbeing, so the market will continue to expand. Targeting users based on needs will provide the greatest opportunity for business growth. (Tao & Textile Institute, 2005) However, those wearable devices are focus on fitness exercises and few products for medical purpose, such as biofeedback devices, are designed for disabled patients but they are not specifically for stroke patients. The good news is that a lot of users’ demands are overlapped regardless of fitness population or physical therapy.

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RESEARCH According to an analysis, Mason's new report, smart bands will account for 90% of smart wearable device sales in developed markets in 2014, but this category will peak in 2016, driven by cannibalization from smart watches with greater functionality, and new devices that serve niche use-cases more capably.

Fig. 2.7 Smart wearable unit sales by device category, developed markets, 2012–2020 (Source: Smart wearables: worldwide market trends, forecasts and strategies 2014–2020)

In addition, Mintel research report claimed that fitness-related wearables are the largest segment within the wearable technology market as a whole. Sales for fitnessrelated wearables grew 118% in 2013, 138% in 2014, and 186% in 2015 and this pattern is predicted to continue. United State wearable technology manufacturer sales are expected to grow annually at a rate of 13% over the next four years,

Fig. 2.8 Adapted from Mintel market research report: wearables technology prediction

which would result in estimated sales of $13 billion by 2020. U.S. wearable technology retail sales should also follow a similar trend.

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RESEARCH

2.1.4 Industry Factors

Fig. 2.9 SWOT analysis

Strengths: By entering the wearables market, we can look forward to high growth potential and achieve lower prices through economies of scale. In addition, even though the target users of this market is fitness population, product diversification will enable us to meet the needs of stroke rehabilitation by offering feature variety and product versatility.

Weaknesses: One of our greatest weaknesses in entering this market will be the lack of technology recognition for stroke patients because the majority of stroke populations are older people. In addition, there are so many different conditions for stroke patients and they have the integrated treatment for their rehabilitation session, including professional therapists, recreational therapists, mental health professionals and physical therapists. It’s hard to see the great improvement by doing one kind of rehabilitation. Patients will be accepted different treatments by different steps.

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RESEARCH Opportunities: It presents a significant opportunity to bring to market what other competitors haven’t through the new technologies in physical therapy area but according to the previous research, the technological research and advancement in wearable devices are mature.

Other competitors thus far have also failed to deliver the style/fashion, durable and comfortable requirements, so this is an area that our design stands to gain from if the design can provide this value to consumers.

Threats: One major threat results from an overcrowded wearable device marketplace. Competition within this industry is fierce when they are entering the medical area. We will experience pressure from the need to continuously innovate and turn our products over quickly so that our products are not passed over by consumers. In addition, consumers may be slow to adopt our product; especially if stroke patients are not ready to adopt the technology.

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RESEARCH

2.1.5 Competitor Analysis

Fig. 2.10 The features of wearable devices (highlighting features for stroke patient needs)

Stroke rehab patients can receive biofeedback training in physical therapy clinics, medical centers and hospitals. A growing number of biofeedback devices and programs are also being marketed for home use, including interactive computer or mobile device programs and wearable devices. Most of biofeedback devices measure physiological changes in user’s body, such as heart rate activity and skin changes (temperature, respiration, stimulation, oximetry, EEG, EMG) in order to reduce anxiety, relaxation, stress and hypertension. eSense, 2Breathe, BosiMetrics and emWave are representative products.

Another type of biofeedback therapy involves wearing a headband that monitors user’s brain activity, such as MindWave, EEG Expert and GSR2. It uses sounds to let users know when the mind is calm and when it's active to help users learn how to control stress response. The price range is incredible huge from $ 13.00 to $ 2600.00. However, stroke patients require additional features, such as posture correction, steps and reps counting and range of motion measuring to improve their rehabilitation at home.

- 33 -

RESEARCH Another category in fitness tracking are smart garments. These are not as popular as the wristband with the general public, because of their high pricing. One of the major competitors is OMSignal which offers a women's sports bra, men’s exercise shirt, and has partnered with Ralph Lauren Polo to create a fashionable men’s exercise shirt. All of these products feature an accelerometer and gyroscope to monitor movement and a chest heart rate monitor embedded in the garment which uses ECG to accurately monitor heart rate.

The sensors are contained in a removable black box that snaps onto the garment at the ribcage. The pricing ranges from $169.00 for the sports bra to $295 for the Ralph Lauren Polo Tech Shirt. Another competitor is Hexoskin, which has a variety of different style smart shirts for men, women, and juniors to monitor heart rate, breathing, and can be worn at night to monitor sleep duration and position. The sensors in these garments are also contained in a packet that is zipped into a pocket for easy washing. The starting price for this shirt is $379.00 on the Hexoskin website.

Wearable fitness trackers can be divided into several categories. At the very basic level and currently most popular among the general public are wrist activity trackers these include the well-known Fitbit and Apple watch. Large sportswear companies such as Nike, Adidas, and Under Armour also have a version of the wristband activity monitor. They have, at minimum, an accelerometer to monitor movement. Some newer models such as the Fitbit Charge 2 are equipped with an altimeter to monitor elevation change and a heart rate monitor. Many models have a sleep tracking feature and some are even water proof (Fitbit Flex 2 and Apple Watch series 2). According to the Fitbit website the price ranges from $59.95 to $249.95 for different models.

- 34 -

RESEARCH The next step up from the basic activity tracker is a multisport ankle band. Moving from the wrist to the ankle allows for better monitoring of the legs in sports. Two of the main competitors in this category are FlyFit and Moov Now. Both bands have the ability to differentiate between sports such as cycling, swimming, and running. Moov Now uses a 9-axis Omni Motion sensor, consisting of an accelerometer, gyroscope, and magnetometer.

Moov Now also features an intelligent app that analyzes and coaches you as you work out, offering suggestions such as to soften your impact during running. Moov Now is listed on their website at a very competitive price of $59.95. FlyFit is fully funded on Kickstarter and will be available to purchase soon.

There is also a branch of smart garments which are capable of measuring muscle fatigue.

Mbody is a company that produces smart fitness shorts designed for cyclists, athletes, and triathletes which feature 6 EMG channels to monitor quadriceps, hamstrings, and gluteus muscle groups. These can be combined with muscle monitor software to evaluate the trainee’s muscular status and fatigue threshold. The Mbody shorts have a detachable sensor box that sits like a belt buckle at the front of the shorts. Athos is another company which offers a shorts option along with a t-shirt for full body sensing. This suit has a total of 26 EMG, 4 ECG, and 2 medical grade breath sensors embedded into the garment. Both Mbody and Athos provide muscle monitoring, and muscle imbalance information, but do not include lactate threshold levels. The Athos set is $390.00 and the Mbody shorts range from $865.00- $920.61.

It seems that there are only two products capable of monitoring lactate levels, BSX Insight and a product called Leo. BSX Insight is a calf sleeve with detachable lactate sensor. It uses led light to “look into the muscle” and determine the muscle oxygenation level and lactate threshold. The app features a training guide with zones based on the lactate threshold.

The product should be used once every 4-6 weeks to perform an endurance test. It is meant for mainly fatigue monitoring and does not offer many of the extra features such as calorie counting that other monitors promote. The starting price for this product is $299.99. Leo is an advanced band which is worn on the thigh during exercise. It promises to monitor steps taken, calories, heart rate, activity recognition, cadence, form analysis, muscle imbalance, muscle monitoring, hydration levels, lactate, and injury prevention.

- 35 -

RESEARCH

2.1.6 Positioning Strategy The perceptual maps reveal that there is a significant amount of competition in the wearables space and they also reveal that there is a significant opportunity to position a wearable technology provider offering a wide range of product features at a lower cost than competitors in this industry. In addition, as a result of our lower price/better feature and stand on the point of stroke patients positioning, a new product in this space may be able to pull some of the market share away from competitors.

Fig. 2.11 Perceptual map: Price vs. Quality

Fig. 2.12 Perceptual map: Price vs. Features - 36 -

RESEARCH

2.2 Customer Analysis 2.2.1 Preparing for Observation

Fig. 2.13 Conversation with occupational therapist at “Steps for Recovery”

Through a series of observations, designers can receive insights into consumers’ behavior, in order to gain a better understanding of how people use products in their daily life (Wasson 2000). To conduct a successful observation, Chris Milton has mentioned a few points to assure the authenticity of the collected data in his book, Research methods for product design (Milton and Rodgers 2013). There are two principles he describes. First, have a specific question or a general sense that more information is needed on a particular topic and then examine the behaviors of people in their natural surroundings over a prolonged period. Second, identify and locate the people for study in a particular environment, culture or geographical location.

Three distinct locations were identified that stroke patients might be contact with - Impact Orthopaedics (They specialize in orthopaedic care and physical therapy for active patients, from experienced athletes to weekend warriors. Their therapists have experiences to treat the stroke patients which could help me compare stroke patients with normal injuries), Postural Restoration Center: Steps for Recovery (They are stroke specific rehabilitation center) and Gentiva (They are a home healthcare center. They act as a bridge between the doctors, therapists and patients).

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RESEARCH

2.2.2 Voice of Customers

Fig. 2.14 Customer characteristics for interviews and surveys

First of all, Medicare and Blue Cross insurance covers physical, occupational, and speech therapies and therefore people with those insurances coverage are most likely to use these healthcare services. The demand for physical therapy rehabilitation center services is highly influenced by the insurance coverage. Especially for the stroke patients who need the long term treatment and there’s no way for them to pay the rehabilitation fee by themselves.

Six in-person interviews have been conducted with three physical therapists, one occupational therapist, and two stroke patients. Two online surveys were sent to professionals (PT, OT, and medical professional) and stroke patients, respectively.

According to the information gained from interviews and online surveys, the treatment includes strength/gait training, balance training, psychomotor development, and functional activity exercise(s). The most frequently affected body parts are elbow, shoulder, ankle and wrist. Particularly, almost all the stroke patients have a problem with wrist. In addition, the therapists claim that all the body parts have strong connection, so wrist relaxing will make shoulder, ankle and elbow relax as well.

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RESEARCH

Fig. 2.15 Therapist demonstrates problematic body parts

Some of the other factors that need to be considered while designing the device are external motivation, exercise role in overall rehabilitation, understanding of exercises, physical therapist’s verbal and visual explanation, physical therapist’s explanation quality, reassessment of home exercises, and satisfaction with a physical therapists.

During physical therapy sessions, stroke patients often have difficulty in keeping correct posture during their rehabilitation sessions. This usually results in not obtaining the expected results and

Fig. 2.16 Therapist guides the correct posture

thereby leading to frustration. Thus, therapists are interested in devices with posture correction functions. Other data like muscle fatigue and muscle activation level is also desired. However, muscle

fatigue doesn’t seem to be a major concern for most physical therapists. Instead, they are more interested in assuring the training is effective. This is done by ensuring correct muscle groups are activated and patients keep correct posture. Muscle activation data are desired by physical therapists but high accuracy is also required. One therapist pointed out that surface EMGs are not able to provide the desired level of accuracy. It would take at least 2-4 weeks before patients could observe their progress. Currently, “Myomo neurorobotic device” used specifically to assist in the recovery of arm movement but it is bulky and users need to carry the battery when they are wearing the device.

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RESEARCH

Fig. 2.17 “Myomo� (EMG robot) which is bulky and mechanical Some

progress monitoring technology would serve to reduce patient frustration. Patient education seems to be a common issue as well because patients are less aware of their body in space and therapists are not able to effectively track patient progress at home.

So, feedback and stimulation are very helpful for the patients at home because they can remind patients. In addition, physical therapists usually have to do some jobs in each session, including measuring the range of motion and counting reps for patients.

Currently, these jobs are being completed manually. Although they are not complex in nature, they do take valuable time from therapists. Consequently, technology to automate these jobs was generally desired by therapists interviewed and surveyed.

Fig. 2.18 Therapist measures the range of motion manually

Fig. 2.19 Multiple buckles with SAEBO stretch glove

Most of the patients have wrist weight, static splint, electrical stimulation device and SAEBO stretch glove at home. However, patients have difficulty wearing those devices because they have many buckles and patients need to be able to put the device with one hand. Also, if the glove is too tight it will cause joint deformities, pain and contractures.

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Fig. 2.20 The issue of static splint

RESEARCH

2.2.3 Findings After having a conversation with therapists and stroke patients, “appropriate form in training” as a core concern for both of them. Some logging/counting service is also desired due to its simple but tedious nature. About 95% of people surveyed showed interest in using a wearable device for monitoring exercise performance and gathering information. About 63% of people surveyed expressed interest in gaining more than one piece of information during training or activities. According to Mintel’s October 2015 report, consumers in the age group of 18-34 were highly interested in wearable technology and mobile apps for tracking activities and other necessary parameters. At the same time, the age of stroke population has decreased during these few decades. Also, customers purchase wearable technologies based on the functions desired (“Wearable Technology,” 2015).

Fig. 2.21 Pie chart for survey results

In addition, according to the above the voice of customers session, we have the following findings and conclusions.

The common treatment plans are: Strength and gait training, balance training, psychomotor development, and functional activity exercise(s).

The most affected body parts are: Elbow, shoulder, ankle and wrist.

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RESEARCH The problems in treatment are: ‣

Incorrect form of patient.

‣ ‣

Manual range of motion, reps, steps and speed measurement.

Unable to track patients’ progress at home.

Patients’ individual frustrations are: ‣ ‣

Maintaining correct posture.

Notification of effective training.

‣ ‣ ‣

Remembering a full sequence of movements.

Too many separate home rehabilitation devices It’s bored to do the whole day proprioception exercise.

Patients’ and therapists’ interests are: Patients’ Needs

Therapists’ Needs Range of motion measuring Progress recording

An integrated device which is easy to maintain, cheap, light and comfortable Posture correction guide

Muscle activation level

Prompt feedback and stimulation

Data upload to therapist synchronously

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RESEARCH

2.3 Key Product Technical Specifications 2.3.1 Patent Search The patent search was mainly based on the technologies identified which are related to the following product design and how they are applied in home rehabilitation tracking.

The keywords used are such as “range of motion”, “wearable + motion”, “wearable + heart rate”, “wearable + lactate”, etc. The search was mainly performed on uspto.com and Google Patent Search. Names and application numbers of identified patents that are closely related to product design in this paper are summarized in the following table. Until now, the technologies that can monitor the range of motion included the digital goniometer, joint/knee brace (biplane goniometer), electronic goniometer, strain sensor, and large rehabilitation equipment.

In addition, there are patents claimed to embed the multiple sensors in the wearable devices, the system to monitor and track the body motion during the rehabilitation process, and the heart rate monitor and lactate sensor are doing the human health examination.

The details on the patents can be accessed online through the application number.

Table. 2.1 Patent search for range of motion Application No. US06367578

Name Digital goniometer

Technology Digital goniometer

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RESEARCH US06453716

Stabilizing knee hinge

Biplane goniometer

US09382433

Orthoses for joint rehabilitation

Biplane goniometer

US06748230

Range of motion measuring and displaying device

Electronic goniometer

- 44 -

RESEARCH US06919880

Force sensing insole for electronic goniometer

Electronic goniometer

US06802578

Range of motion limiting device

Large equipment

Strain-sensing goniometers, systems and

Strain sensor

US07625305

recognition algorithms

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RESEARCH

Table. 2.2 Patent search for motion tracking and other related technologies Application No.

Name System or device with wearable devices

US14051093

Technology Multiple sensors

having one or more sensors with assignment of a wearable device user identifier to a wearable device user

US13866137

US20100176952A1

Cognitive function evaluation and

Body motion

rehabilitation method and system

System for detection of body motion

- 46 -

Body motion

RESEARCH

US14018262

Systems, devices and methods for continuous Heart rate monitor heart rate monitoring and interpretation

US20120095352A1

Health monitoring application

Health monitor

US 15070412

Wearable lactate threshold monitor

Lactate sensor

Real-time and continuous determination of

Lactate sensor

US2015/018303

excess post-exercise oxygen consumption and the estimation of blood lactate

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RESEARCH

2.3.2 Key Components Definition

Fig. 2.22 Technical analysis via problem finding and customer needs

In conclusion, according to the previous secondary research, primary research and technical patent search, reverse problem faced and patients & therapists needs of technical options revealed the flex sensor, potentiometer, LiPo battery, IMU unit and app design are the key components usage for the following design development.

For wearable technology, flex sensors are used to accurately measure joint angles.

Compare to traditional stretch sensors, it is much more stable, durable and it can fit under clothing.

A potentiometer is a simple sensor that provides a variable resistance, which people can read into the Arduino board as an analog value. It is essentially a voltage divider used for measuring electric potential and detecting muscle activation.

Battery is another key component of the wearable device. Its properties (i.e., size, duration, chargeability) can influence user experience. The competitors mainly use Lithium-polymer batteries, with a battery duration of about twelve hours.

IMU unit is an electronic device that measures and reports a body's specific force, angular rate, and sometimes the magnetic field surrounding the body, using a combination of accelerometers and gyroscopes. So it is used for reps and speeds counting easily.

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RESEARCH For app development, Microsoft Kinetisense has a very nice interface for both the patients and therapists. The software provides real-time video analysis with angles of the body shown on the patient. It can also provide analytical data and graphs to monitor progress.

However, patients are limited to specific area to do the exercises. The following design plans to build the mobile app prototype via Just In Mind or Axure.

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RESEARCH

2.4 Design Goal

Fig. 2.23 Expected use scenario

Physical therapy exercises are often assigned for stroke patients to complete aspects of their treatment at home. Sometimes results are ineffective due to non-compliance, lack of awareness of body postures or improper routines being performed. Physical therapists need a way to track patient activity and monitor progress. The thesis aims to develop an innovative device, based on smart sensors, which allows therapists to monitor a patient’s progress, detect range of motion, guide posture correction, record exercise data, such as muscle activation level, speeds, reps and analyze the information in order to adapt treatment plans as necessary.

In order to make sure the following design could be successful, the researchable questions and design assumptions of this research area are: Researchable questions: “How could stroke patients improve their therapy and rehabilitation at home?” ‣

How do therapists decide on a course of treatment?

‣ ‣

In what capacity would a monitor/device provide benefits to patients?

How could the monitor/device show the patients’ improvement?

Design assumptions: ‣

The technology/device are already available and can be incorporated into the design.

‣

Patients could check their data and watch the template of exercises by each device (i.e. computer, ipad, smart phone).

‣

Monitoring patients at home would be helpful for their recovery.

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3 CONCEPT 3.1 3.2 3.3 3.4

User Scenario and Narrative Functional Study Stroke Wrist Support Product Analysis Expected Use Product Workflow

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CONCEPT

CONCEPT 3.1 User Scenario and Narrative The primary usage environment for this project is home care and rehabilitation settings.

In recent decades, home care rehabilitation settings are a trend for stroke patients because most patients will need some form of long-term services and support in their lifetime. The advantages of home care and rehabilitation are: -

-

-

Cost-effective: Home care offers individualized services that are tailored to the patients’ health care needs and finances. There are no room and board costs compared to nursing homes, rehabilitation centers, and other institutional care settings.

Flexibility: Patients get to be creative in their treatment plans. They could set their own schedule around their doctors’/therapists’ appointments.

Great improvement: Home care promotes healing, as studies have shown that patients recover faster in the comfort of their home (National Institute of Neurological Disorders and Stroke, 2015).

Family support: Home care reinforces and supplements care from the patients’ family and friends.

Based on the previous research, the most affected body parts for stroke patients are elbow, shoulder, and wrist. Therefore, this project will focus on upper extremity exercise for the wearable device design.

According to the primary research (observation, survey and interview) addressed previously, there are several issues existed for both therapy treatment and home rehabilitation.

To first explore the problem, user scenario boards were created for both stroke patients and therapists in order to understand the system level to determine what kind of usage condition is the most appropriate for the various stakeholders.

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CONCEPT User scenario boards were reviewed by 5 professional therapists and 4 stroke patients.

The overall preference was “scenario 1” for stroke patients (combine mobile apps with wearable device). It is best without in-ear headset as the primary source giving patients verbal instructions. There are some patients with sensory (or global) aphasia who have difficulties understanding verbal commands. Many of them wear ear hearing aids and are unable to wear in-ear headset simultaneously. At the rehabilitation center, they communicate with therapists by body language or observations, but it’s hard for patients to understand instructions just via voice tutor. Besides, visual delivery is faster than auditory delivery, so watching rehab tutorial via mobile apps directly is a better way for patients when they are doing the home rehabilitation.

“Scenario 2” was preferred by therapists (both therapists and patients use mobile apps for progress tracking and reviewing) because it is in accordance with the trend of using apps (via tablet and mobile phone) as a tool for health care. It’s more practical, portable and convenient.

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CONCEPT

Fig. 3.1 User scenario boards for stroke patients and therapists - 54 -

CONCEPT

3.2 Functional Study In order to identify the future product details, the following survey detects stroke patients’ condition at functional stages of their therapy session.

- 55 -

CONCEPT

Fig. 3.2 Functional study survey - 56 -

CONCEPT The following are the results of functional survey: 1. Therapists state that it is not necessary to massage and relieve muscles before patients do home rehabilitation because some patients are physically unable to do self-massage and patients can potentially damage their muscle if they do it incorrectly.

However, 15 mins hot compress is recommended if patients have time and strong intention.

2. Therapists suggest patients use theraband when they do home rehabilitation because it is versatility of changing magnitude and direction of resistance. Also, dumbbell and wrist weight can be replaced by theraband. However, for the early treatment, they use cane/walking stick to assist patients’ spastic hand to do the exercise.

3. Although some people may have more flexible joints, the normal ROM for most of the population are wrist flexion 80 degrees; wrist extension 60 degrees; wrist radial deviation 20 degrees; wrist ulnar deviation 45 degrees; elbow flexion 135 degrees; elbow extension 0 degrees; shoulder flexion 180 degrees; shoulder extension 60 degrees; shoulder abduction 180 degrees; shoulder internal rotation 45 degrees; shoulder external rotation 90 degrees.

4. Patients usually are not able to reach normal ROM easily. Therapists do not push patients to do more degree than the normal standard. If patients’ ROM are sufficient to perform the daily activities with least assistance from the caregiver, it’s usually acceptable.

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CONCEPT 5. The home exercise programs are prescribed depending on patients’ needs and no any exercise is more important than others. However, therapists recommend to focus on the elbow and shoulder exercises because it’s easy to see patients’ progress. In order to make sure patients’ hand is not getting worse, the routine hand exercise is necessary, but hand and finger are hard to recover for the stroke patients.

6. With a neurological population, therapists are working on gaining movement/motor control and less on “nerve gliding” and “tendon gliding” which are typically used with orthopedic/surgical population.

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CONCEPT 7. Therapists recommend upper extremity exercises for stroke patients including forearm stretches, forearm supination/pronation, elbow pushing down, elbow flexion/extension with theraband, cane standing/sitting side push, cane arm stretch, cane standing circle and cane sitting stretch forward. In addition, patients need to be aware of keeping their torso straight when they are doing those upper extremity exercises at home because most of patients tend to put forward their body when they are performing exercises. The effective exercises can make a great improvement for stroke patients.

8. Repetition, frequency, rest periods, ROM and torso straight tracking are information that therapists want to track over time and review during their regular follow up appointment with patients.

Fig. 3.3 Upper extremity exercise for stroke patients (selected by therapists)

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CONCEPT

3.3 Stroke Wrist Support Product Analysis Most stroke patients have joint deformities, pain and contractures issues with their hand. In order to achieve a neutral position, they need to wear a static splint. There are variety of static splints on the market with different materials, and functions. A fingerboard is a

Fig. 3.4 Spastic/affected hand post stroke

common splint for stroke patients.

There are many issues for stroke patients when trying to put on fingerboard with only one hand. First, stroke patients have difficulty to open hand and separate fingers because they have spastic/affected hand. Second, Velcro straps on the fingerboard unintentionally stick Fig. 3.5 Static splint for stroke hand support together easily, making it hard to manage.

Third, straps easily become unattached from the board and it is difficult to re-thread the splint. Fourth, it’s hard to tie and adjust each finger with the strap. Fifth, the fingerboard doesn’t exactly fit patient’s hand well. Lastly, hard and flat fingerboard interfere with wrist. It’s uncomfortable to wear it for a long time. It is hard to achieve a natural, neutral posture of the hand with the limited range of sizing and lack of accommodation to the size and form of the boards.

Fig. 3.6 Fingerboard wearing process with pain points - 60 -

CONCEPT

3.4 Expected Use Product Workflow

Fig. 3.7 Wireframe for product expected use

The wireframe is split to two sections: home and rehab center. Stroke rehabilitation is a long term treatment and it is important to keep on schedule, so patients go back and forth between home and rehab center is their routine schedule.

The expected product for this project is a system which is includes mobile apps, upper arm sensor, posture sensor and wearable device. The detail of entire system is mentioning as:

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CONCEPT Usually, Therapists recommend stroke patients to do the home rehabilitation twice a day.

First of all, the sensors and device are connected to mobile apps. Stroke patients choose training program they want to complete first, which is assigned by therapists, watch program tutorial via mobile apps and start home rehabilitation at the same time. Lastly, patients can review the training progress when they finish the program.

In addition, stroke patients have a regular meeting with therapists twice a month at the rehab center. At this time, therapists open their higher authority, track patients’ progress via apps, and give them advices. Finally, therapist assign the new training programs for patients based on their improvement and status.

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4

DESIGN DEVELOPMENT 4.1 Design Criteria 4.2 Wearable Device Concepts Development 4.2.1

Sketch Ideation

4.2.2

Full-scale Prototyping

4.2.3

Users Testing and Feedback

4.3 App Platform Definition 4.3.1

Brand Development

4.3.2

Workflow of CT App

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DESIGN DEVELOPMENT

DESIGN DEVELOPMENT 4.1 Design Criteria Multiple function: ‣ ‣ ‣

Attachable wrist support Both hand wearing Various exercises (putty, wrist weight, cane, theraband……)

‣ Expand palm/fingers of hand Easy care/user-friendly: ‣ Easy to wear/tear off for one hand (minimize wearing steps) ‣ Easy to set up ‣ Waterproof and washable Smart connection/tracking: ‣ ‣

Embedded sensors (Bluetooth, IMU unit) Repetition, frequency, rest periods, ROM and torso straight tracking

- 64 -

DESIGN DEVELOPMENT

4.2 Wearable Device Concepts Development 4.2.1

Sketch Ideation

In accordance with the design criteria, the sketch ideation is categorized to three areas: multiple functions, easy care (user-friendly), and smart connection (tracking).

The idea of multiple functions is foscused on interfacing with extra assistive equipment, such as putty/ball, wrist weight, cane/walling stick and theraband, both hand wearing device and palm (fingers) expansion.

Reducing the presence of elastic bands, buckles and straps are the solutions for the easy care and user-friendly. Easy to wear, take off, and set up are very important for stroke patients when they wear this kind of device with one hand at home.

Bluetooth and IMU unit (accelerometers and gyroscopes) are embedded sensors in mobile apps and devices for connection and program/body tracking.

- 65 -

DESIGN DEVELOPMENT

Fig. 4.1 Wearable device sketch ideation - 66 -

DESIGN DEVELOPMENT After ideation synthesis, three major design directions emerged for the stroke rehab system.

Direction A: Glove type wearable device. There’s a pocket attached on the top of the device. To make fingers flexible when take-off pocket (patients can do the finger exercise).

To expand spastic/affected finger when wear pocket.

Direction B: Paddle type wearable device. To tie fingers and palm on the top of paddle (minimize to one wider strap). Patients do the wrist exercise when they detach wrist support. They do elbow/shoulder exercise when they attach wrist support (attachable wrist support).

Direction C: Paddle type wearable device. To tie fingers behind the paddle (minimize to one wider strap). Patients can touch something when they wear paddle (reserve touch feeling for patients). Patients do the wrist exercise when they detach wrist support. They do elbow/shoulder exercise when they attach wrist support (attachable wrist support).

- 67 -

DESIGN DEVELOPMENT

Fig. 4.2 Wearable device design directions

- 68 -

DESIGN DEVELOPMENT

4.2.2

Full-scale Prototyping

Fig. 4.3 Wearable device prototype testing (Paper prototypes to evaluate product size and form)

Physical models were developed for therapists and stroke patients to review and obtain a greater understanding of the product. Full-scale prototypes were created for above three design directions. Users tested various design features, verified design functionality, and reviewed initial product shapes by engaging with prototypes.

- 69 -

DESIGN DEVELOPMENT

Fig. 4.4 Wearable device full-scale prototype for three design directions

- 70 -

DESIGN DEVELOPMENT

4.2.3

Users Testing and Feedback

Fig. 4.5 Users testing and feedback for wearable device prototype

Prototype testing was conducted with four professional therapists and three stroke patients. In order to narrow the set of alternatives under consideration, a concept selection form (product preference survey) was used. The selection criteria referred to previous design criteria which is based on user needs and business objectives. Users rated each selection criteria (1 is the lowest rating, 5 is the highest rating) under each design direction. In the end, “Direction A” got a higher score because glove type design was deemed the most comfortable and users were willing to wear it for a long time at home.

“Direction A” then underwent further investigation and development of wearable device in this project.

- 71 -

DESIGN DEVELOPMENT

Fig. 4.6 Concept selection for three design directions

Within “Direction A”, three design variations were developed after seeing users interact with the prototype: double side wrist support, top wrist support and back wrist support. After more evaluation, the top wrist support got the higher rank because it’s easy to put on and off and didn’t lose wrist support function.

Fig. 4.7 Three potential designs for Direction A

- 72 -

DESIGN DEVELOPMENT

4.3 Apps Platform Definition 4.3.1 Brand Development

Fig. 4.8 Brand logo exploration (Chose “Circular Therapy” as brand name)

Stroke is a long term treatment. Both patients and therapists need to be patient and keep doing the rehabilitation programs for a long time. “Circular Therapy” is a term to remind and encourage stroke patients to do the exercises at home which are assigned by professional therapists.

This project chosen the brand icon which is including a person and a circle in order to emphasize on home is a union that family’s support has a great effort and influence with stroke patients. The green color is a symbol of health, energy and animation.

Unlike traditional paper-based therapies that rely on static and manually delivered exercises, “Circular Therapy” provides dynamically updated exercises customized for each stroke patient. It is designed to be used independently by anyone seeking to improve brain function and in conjunction with a clinician as an integral part of therapy

- 73 -

DESIGN DEVELOPMENT

4.3.2 Workflow of CT App

Fig. 4.9 CT app design (Workflow & Iteration)

There are four sections included in CT app design, connect device, exercise, progress, and notification. Initially, patients sign in with email/password. Then, the CT app system will remind patients to turn on Bluetooth. Technically, the system searches and links with “CT DEVICES” automatically. If system can’t find the devices, it will remind patients of turning on “CT DEVICE” power and reconnecting with system until entering the main menu.

- 74 -

DESIGN DEVELOPMENT

Fig. 4.10 CT app design (“connect device” session)

Second, when patients enter the exercise page, all the exercises are assigned by therapists (it is based on patients’ status and treatment plan, so each patient has different assignments). In addition, the system shortly shows daily finished target on each assigned exercise on this page. Then, patients are able to review today’s assigned tasks and history record in detail after click the selected exercise. When patients decide to start doing the exercise, the exercise video are playing with real-time counter to enhance exercise experience and improve exercise accuracy. If patients pause their action for a while during their exercise session, the system will remind them to “keep going” or stop and save the record of this session automatically. On the other hand, if patients do more than ten repetitions during the exercise session, the system will remind them to “stop” and finish this session.

- 75 -

DESIGN DEVELOPMENT

Fig. 4.11 CT app design (“exercise� session)

Third, the system shows the current percentage of elbow/shoulder ROM achieved for each exercise on progress page. When patients/therapists click the exercise, they can review and track the overall detail results of this exercise, including reps completed, the percentage of accurate reps, frequency, rest period and the percentage of ROM achieved.

The progress reports are divided by today, week, month and year. Also, patients/therapists can manually chose the date range of report that they want to track back. Finally, therapists will be able to access progress information to optimize and plan the suitable treatment program for the patients

- 76 -

DESIGN DEVELOPMENT

Fig. 4.12 CT app design (“progress” session)

Lastly, patients can access notification page to contact with therapists anytime and anywhere when they have questions at home. Also, therapists could leave advices for each exercise by this page after they review patients exercise record. The setting page allows patients setting up the frequency of “CT DEVICE” alert for exercise reminder. The profile page is decided by patients’ intention. They can determine whether they want to fill out personal information for system database used or not.

- 77 -

DESIGN DEVELOPMENT

Fig. 4.13 CT app design (“notification” session)

- 78 -

5 FINAL DESIGN 5.1 CT Device 5.1.1

CMF and Detail Definition

5.1.2

Working Prototyping

5.2 Applications 5.2.1

CT Device/App Simulation

5.2.2

Users Testing and Feedback

5.3 Further Development

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FINAL DESIGN

FINAL DESIGN 5.1 CT Device 5.1.1 CMF and Detail Definition The “CT Device� is a package which includes the wearable device, posture sensor and upper arm sensor. The primary function of wearable device is wrist support and spastic/affected finger expansion. The upper arm sensor is work co-operatively with wearable device sensor for elbow/shoulder ROM measurement. The posture sensor is a reminder in order to ask patients to keep torso straight when they are doing exercises.

Fig. 5.1 CT Device (Including wearable device, posture sensor and upper arm sensor)

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FINAL DESIGN

Fig. 5.2 Wearable Device: Functional Details

One strap design for wearable device which fits in thumb and wrist circumference is simple wear and set up. Pull and tight pocket strap to expand patients’ finger easily. The hidden static splint on finger, wrist and thumb is a great support for patients’ spastic/affected hand.

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FINAL DESIGN A soft, micro-fleece lining was selected for the wearable device which is a high-tech fabric and has good breathability for body heat and moisture vapor pass through.

The three layers of material are radial stretch nylon lycra, smart skin membrane and fast-wicking soft micro-fleece.

Fig. 5.3 Wearable Device: Materials

Fig. 5.4 Posture Sensor and Upper Arm Sensor: Functional Details

The snap bracelet spring design for upper arm sensor is easy for patients wearing it for one hand. Weighted strap design for posture sensor without any buckle and attachment, patients can hang it up on shoulder directly. Badge reel design for storage mode which assists upper arm sensor to attach with posture sensor automatically and prevents components from being misplaced.

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FINAL DESIGN

5.1.2 Working Prototyping

Fig. 5.5 Wearable device working prototype testing

Fig. 5.6 CT sensor working prototype testing (Upper arm sensor and posture sensor)

Four participants, two males and two females, test working prototype and figure out the best size for general users. The user suggestions are the length of pocket strap with wearable device is not long enough for male users, it’s easier for users to hang posture sensor up on their shoulder if the design adds more weight in the end of strap, and it’s easy to wear upper arm sensor upside down if there’s no any indictor. After refining the working prototype, the next step will bring it to end users testing (stroke patients and therapists).

Fig. 5.7 CT sensor wearing process - 83 -

FINAL DESIGN

Fig. 5.8 Wearable device in use

Compared to the current stroke static splint, the wearable device design reduces the number of steps needed to put the device on and saves more than half time. In addition, the breathable material is comfortable and users are willing to wear it for a long time even if they are not doing exercises. And this is good because the longer time they wear device, the greater improvement for their spastic hand.

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FINAL DESIGN

5.2 Applications 5.2.1 CT Device/App Simulation The overall CT device is including CT App, wearable device, upper arm sensor and posture sensor. A functional pocket attaches with wearable device to make fingers flexible.

Patients grasp cane and do exercises when they take off pocket. Patients wear pocket to expand their spastic/affected fingers.

Fig. 5.9 Removable pocket for cane exercises

The power buttons on “CT Device” are turned on when the indicators show green light.

The flash green light per one second means “CT Device” is connecting with “CT App”. The red light means the failure connection between “CT Device” and “CT App”. If the sensors are vibrating, the system reminds users there’s an incorrect posture happened.

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FINAL DESIGN

Fig. 5.10 CT Device indicators

Fig. 5.11 Mobile Platform: CT App

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FINAL DESIGN The cornerstone of this project is creating a reliable at-home exercise assistance for stroke patients. “CT app� will work with both stroke patients and therapists, provide detailed exercise tutorials, calendar, real-time data and feedback. Finally, it assists stroke patients to improve their health under the guidance and supervision of their physical therapists in the convenience and comfort of their home.

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FINAL DESIGN

5.2.2 Users Testing and Feedback

Fig. 5.12 User testing and feedback for working prototype

Three professional therapists and two stroke patients were included for working prototype testing. Using “CT Device� in the real treatment program to replace current static splint. Users are actively involved in the development. Since in this methodology a working model of the system is provided, the users get a better understanding of the system being developed, including physical model and mobile app simulation. As a result, all participants have a high positive feedback to this innovative design. They are interested in seeing it in real action in the future.

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FINAL DESIGN

Fig. 5.13 Treatment program with CT Device

The suggestions for CT device are: 1. Replace pocket strap to inflexible material in order to expand finger tightly.

2. Thin and breathable fabric is useful for patients to wear it for a long time.

3. Consider the size and both hand wearing.

4. It’s easier to hang up on the shoulder if add more weight on posture sensor The suggestions for CT app are:

1. Set up the rest period, duration and repetitions for specific exercise.

2. Customized use in progress report. For example, therapists have an authority to decide what information will be shared with patients and their family, or patients can decide what kind of information they want to review.

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FINAL DESIGN

5.3 Further Development Future improvement can be made into three direction: 1. Increasing comfort, 2.

Improving efficiency and 3. Creating personalization Regarding comfort, using a composite and high-tech material that combines micro-fleece lining with static splint on the wearable device can enhance breathable, the body heat and moisture vapor can pass through by this material.

In addition, adding an extra buckle on wearable device could help the users better distribute the overall force to the whole hand while they pull pocket strap to expand their strong spastic finger. In consideration of multiple users, different sizes and both hand wearing should also be added on the future prototypes.

Fig. 5.14 Further development

There is also the potential for posture sensor to further improve the efficiency. By adding more weight on the end of strap, it is easier to hang and set up on the shoulder without any attachment. Using touch button and embedding LED ring around the strap, including posture sensor and upper arm sensor, can also add extra visibility and intuition because acting as visual indicator to guide users to wear those sensor on the right direction.

A method to improve efficiency of this product include a customized progress report which allow users setting up the information for reviewing and tracking. Depending on users personal treatment plan and physical status, assign the rest period, duration and repetitions for specific exercise.

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FINAL DESIGN Future development can be achieved by using production-level material and ergonomic testing in an interdisciplinary team with designers, engineers, programmers and fabricators because “Circular Therapy� is a holistic system. It might take a while for a system to be built that allows ease of use and needs minimal training for the end user.

Product implementation and application by using ethnography method to ensure that the end users constantly work with the system and provide a feedback which is incorporated in the prototype to result in a useable system also plays an essential section in the future works.

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6 CONCLUSION 6.1 Final Thoughts

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CONCLUSION

CONCLUSION 6.1 Final Thoughts

Fig. 6.1 CT Device and CT App

Using a static splint (finger board) has been a long-standing solution for many stroke patients. However, this solution is not optimal due to uncomfortable wear and no motivation or feedback. This latter is a noticeable and difficult issue for stroke patients and creates a barrier between them and their therapists.

Though this problem can possibly be solved by increasing the rehab appointments with therapists, it is unlikely difficult and expensive, which means wasting medical resources and therapists still can’t track patients progress at home. The integrated device designed and developed within this project can influence the users’ behavior and lead to a better experience.

“Circular Therapy” differs from the many attempts to create a static splint with multiple functions. Beginning with understanding the users’ perspective, including stroke patients and therapists, developing the design by extracting the strengths of conventional product and current rehab center system, and combining them to fit into the specific context. The goal of the design is to give the stroke patients the confidence to do exercise at home, keep tracking their improvement, have a good recovery of their spastic hand and have a direct communication with therapists.

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CONCLUSION In conclusion, many of us have a simple goal: to be our best. This require commitment, discipline and focus and requires precise tracking. “Circular Therapy� provides a different solution to the long-standing problem of stroke rehabilitation and has the potential to have a positive impact on many users.

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