Romi

ROMI

(Range Of Motion Indicator)

Lizzie Greenwood lizziegreenwood@hotmail.co.uk

PROBLEM SPACE AND RATIONALE FRAMING THE PROBLEM 1. Demand for physiotherapy vs staffing 30% of primary care consultation is accounted for by repeat consultations with GP’s for musculoskeletal disorders (CSP, 2012) 41% of Physiotherapy managers in the UK agree that there are “inadequate physiotherapy staffing levels” (CSP, 2012)

“Putting the ownership back on the patient is key” Physiotherapist, Leeds Lizzie Greenwood

2. Scheduling prescribed treatment with existing commitments 31% of people experience pain at work at least once a week (CSP, 2012).

A key part of prescribing treatment for patients involves a home exercise plan containing exercises for mobilising and strengthening joints. These plans contain repetitive exercises specific to the patient’s complaint and involve patients investing time into completing them regularly (up to hourly frequencies) and for the prescribed duration (up to a year) to enable full rehabilitation. = Low adherence rates to prescribed exercise plans (Ludwig & Adams: 44%, Slujis et al: 70%) WHY? SELF VARIABLES

SITUATIONAL VARIABLES

KEY

“I didn’t know how much pressure to apply”

“I had no way of measuring my progress”

Lack of fun

“If patients do their exercises wrong it can aggrevate the condition”

Despondancy: over long rehabilitation periods patients lose motivation

Finding time: pressures of working life take time priority

MONITORING ACCURACY

PHYSICAL PROGRESS TRACKING

GAMIFICATION/ SOCIAL INPUT

UNIVERSITY OF LEEDS 25 PRODUCT DESIGN

PROBLEM SPACE AND RATIONALE

RESEARCH SUMMARY

DISCOVERY PHASE

USER INSIGHT

USER INSIGHT STAGE ONE: (UNDERSTANDING THE PROBLEM)

Lizzie Greenwood

3 participants who had previously had Actions: physiotherapy treatment of varying length - Development of 3 directions based on most were used. This was deliberate so that any common needs discussed. behavioural patterns could be cross-assessed to determine if severity had any impact.

3 local physiotherapists also agreed to take part in the project. In stage one they were asked for their expert opinion on the most common unmet patient needs.

STAGE TWO: (TESTING OF 3 DESIGN DIRECTIONS) Aim: To gain feedback on the following 3 product directions at a very early stage from experts: - Monitoring accuracy - Tracking progress over time - Increasing “fun” (Gamification/social input) These were discussed with two experts.

Insights: - Both practitioners questioned chose the “Progress Tracking” direction as the most promising.

- Concerns were expressed around any product that would try to objectify personal goal setting.

- Long term rehabilitation post joint replacement suggested as potential area of product need.

- Product that is adaptable to several joints desirable

Actions: - “Progress tracking” chosen as final product direction (after evaluation against specification and stage 2 research) - Research into joint replacement/longer term rehabilitation carried out: flexion/extension motion rehabitation

STAGE THREE: (TESTING OF CHOSEN DIRECTION EMBODIMENTS) Aim To gain feedback on current embodiment forms from patient with experience of long term knee range of motion rehabilitation.

Insights: - Patient liked the prototype where the main bulk of the product was away from the joint.

- Patient felt weary of the prototype that sat Actions: away from skin as she thought it could be - Prototyping focused on moving the bulk of knocked easily. the system (the electronics hub) away from the - Patient weary of weight on vulnerable joint. joint.

- A product which could be worn all day with - Mechanical requirement to make the device the electrical section added to record data as lightweight as possible prioritised. desired.

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STAGE FOUR: (TESTING OF ATTACHMENTS) Aim To understand how intuitive different styles of attachment are to naive consumers in order to select the option which gives the patient the easiest experience of using the product as possible.

Two naive consumers were encouraged to play with the 4 different mechanisms unprompted and to voice opinions of them. They were then asked which option they found easiest to use.

Insights: - Users found the luggage clip option difficult to use as it was stiff to open and close.

- Users liked the idea of an “SD Card” style click-in mechanism.

- All options required movement back into the body of the object- which when on the joint would not be possible: a redesign of attachments that secure from above is necessary.

Actions: - Design of attachment mechanism from above rather than linearly begun.

- Preference for sensory feedback (click) taken on board for development of final attachment mechanism.

Lizzie Greenwood

STAGE FIVE: FINAL USER TESTING RESULTS: The user found putting on the knee support intuitive as they were very used to this process.

On inspection of the prototype, they understood that the ends needed to be attached onto the clips but needed to be prompted as to how.

Once attached, they found using the product very intuitive as it did not change their exercise at all.

PATIENT EXPERT “Could be a real benefit for postop knees” “Practical to sell at a patient level” “Where patients get lost with self-management is the feedback you need, which that App would tell them”

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USER INSIGHT

“The attachments might have an annoying wobble factor during exercises. Needs to be more secure.”

DESIGN PHASE Lizzie Greenwood

DESIGN PHASE Initial concepts centred around any product which could help the patient to improve their adherence to exercises. Unprompted, these mainly consisted of ideas in the themes of: - Devices which could remind the patient to carry out their exercise (e.g. alarm-style) - Devices which made doing exercises more fun (games etc) - Devices which gave the patient a reward for completing their exercises (e.g. biofeedback such as vibrations) or rewards such as chocolate.

- Devices which helped the patient to understand how accurately they were carrying out their prescribed plan.

- Devices which monitored motion.

Design direction one: Monitoring accuracy One patient interviewed voiced the concern that he wasn’t sure how accurately he was repeating his exercises. He used a prompt sheet to remind himself but found the diagrams confusing.

Through sketch development and after User research stage one had been carried out, the following three Design directions were concluded:

Product idea: Wearable accuracy tracker (Right) Design direction two: Tracking progress The patient with the highest severity of injury interviewed voiced her greatest concern which was that she found it very difficult to know if she had made any progress over her long term rehabilitation in getting back to full range of motion. This made her frequently despondant and reduced her motivation to complete her exercises.

Product idea: Wearable motion range tracker Design direction three: Gamification The lower severity patients both mentioned that they found their exercises dull and repetitive.

Product idea: Interactive game with timed prompts.

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RESEARCH: Through prototype experimentation it had been found that three main ways of achieving the desired product outcome could be developed.

PROTOTYPES: All prototypes were deliberately low fidelity and made using a selection of foam, hard-bake clay and acrylic:

Over joint, flat to skin

Over joint, away from skin

Offset from joint, flat to skin

EVALUATE: This evaluation was carried out in User research stage 2, with one focus participant.

The patient chose the offset embodiment as her favourite, as it was away from where she felt most vulnerable.The patient chose the direct/away from skin embodiment as her second choice but had concerns that it may knock into things. These two products (with emphasis on offset embodiment) were therefore taken forward for development.

Lizzie Greenwood

INITIAL ELECTRONICS PROTOTYPING: Component selection carried out involving constraints of ability to measure relative position from a reversible oscillatory input and providing an initial feedback read aswell as data storage for an App graphical representation.

Initially, a rotary potentiometer was used for prototyping for ease of understanding, with the intent to use a rotary encoder system.

A protoboard and MYDAQ were used to prototype a feedback system where the output voltage of a rotary potentiometer controlled the lighting of 3 LEDs.

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DESIGN PHASE

A wearable prototype embodiment (right) was created to test the sensitivity of the electrical signals involed in response to the human movement anticipated in the final product use, and to use as a working prototype to develop a LabView programme with. This prototype involved the design of a potentiometer housing Further development involved programming which could be bolted to the board to provide using LabView and signal creation through the adequate stability to withstand the forces gear motion output. exerted.

DESIGN PHASE

EMBODIMENT DEVELOPMENT: PROTOTYPE: After the evaluation carried out in User research stage 2 and after assessing the input needs of the electronic system, the following embodiments were prototyped:

Lizzie Greenwood

OFFSET DEVELOPMENT The development of offset weight embodiments was prioritised due to patient preference. It was decided to develop the Spur Gear embodiment due to the following factors: - The output of the mechanical system (rotary in either orientation) can be used as the input to the electronic system.

- The sprung rack and pinion system requires the user to work against the spring force, this is undesirable as it adds resistance for the vulnerable joint to work against.

SPRUNG RACK & PINION:

SPUR GEAR:

An idler gear was introduced in the embodiment design in order to allow for full 160 degree motion from horizontal (in previous two-gear design, the moving arm collided with the product body towards the upper limit.

FINAL DESIGN: Instant sensory read ROMI SMART out of performance £27.99 Electro-mechanically enabled Tracks performance over time to App Instant dial read out of performance Mechanically enabled

ROMI SIMPLE £15.99

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SOLUTION SPACE ROMI: A product for long term rehabilitation of the knee, wrist or elbow to enable progress tracking.

Worn during exercises, ROMI automatically tracks your range of motion. In ROMI Smart, this data is stored to an APP.

FUNCTION:

MATERIAL Polypropylene

Lizzie Greenwood

With everyday use, ROMI can be attached simply by pressing the ends into the clips from above, and released by pulling out. The clips allow the whole product to follow the natural radial deviation expressed by dynamic joint movement while keeping the product stiff to mechanically translate flexion and extension.

PROCESS USED Injection Moulding

1

Various

Standard components

2

POM (Delrin)

Standard components (Injection Moulded)

3

Steel (Low alloys)

Sheet metal forming

4

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SOLUTION SPACE

Smart/ Simple RRP: £27.99/£15.99 COST: £19.60/£13.87 PROFIT: £8.39/£2.12 SALES: 2600/1300

SOLUTIONS SPACE Lizzie Greenwood

EVALUATION REQUIREMENT SCORE

TEST METHOD

EVIDENCE

FINAL

Allows individual use

5

Product trial evaluation of ease of use

Romi is designed for solo use.

Considerations of feedback visibility, size and portability have accounted well for this.

45/50

Aids tracking of injury over time

5

Product trial evaluation of ease of use

Dependant on variant, Romi can either track to an APP or facilitate manual record taking by providing a readable value

50/50

Price suitable to individual purchase

5

Pricing of components using CES Edupack/ RS Components estimations

Both variants are below ÂŁ30, a reasonable estimation for a medical related product.

40/50

Suitable for home & clinic use

5

Focus group use (3 male 3 female) & physiotherapist feedback

Rechargeable through a USB connection, either home or clinic acceptable.

Polypropylene surfaces are suitable for medical standard cleaning.

40/50

Gives instant user feedback

5

Prototype test.

Feedback log and resulting actions

Both variants give instant on-board feedback as a result of motion.

40/50

Adaptable to different joint sites

3

Trial on all hinge joints, evaluation of accuracy of read vs manual recording by other person with standard Goniometer

Can be used on knee, elbow or wrist joint

24/30

Allows goal setting (Individual)

3

Product trial evaluation of user information input.

EVALUATION

Currently not accounted for but with development of APP this functionality can be achieved.

18/30

The device meets many of the criteria set by the users (both by practitioners and patients) and has succeeded in being adaptable, useful and fit for purpose.

It has a modular foundation and can be purchased in two product forms (smart or simple) dependent on user preference. To develop the project further, I would focus development on improving the attachment system.

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