FES Cycling - Q&A

Questions and Answers July 2012 - RehaMove and RehaBike - FES Cycling What does an FES Cycle do?

Functional Electrical Stimulation (FES) has long been a research technique activate paralysed muscle with low levels of pulsed electrical current. The current is applied using adhesive pads (electrodes) over the muscles in question.

The equipment we offer (RehaMove and RehaBike) builds on this research and combines a sophisticated system of delivering stimulation to muscles with a motorised ergometer (cycle). The stimulation unit (RehaStim) included as part of a RehaMove or RehaBike system is a very flexible and powerful system that can coordinate the stimulation of up to 8 muscle groups with the movement of the pedals of the cycle (or an arm crank too if the model has the arm training accessory). By adjusting the stimulation, the user can easily set exercise targets to work progressively against resistance. Individuals can gain important health benefits through regular use.

RehaMove One used

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Can I use your FES cycling equipment?

Almost certainly if you have a spinal cord injury with an intact lower motor neuron - the equipment can be used whether you are sensory complete or incomplete - best chance is between C5 and T9. Check out the benefits, features and contraindications over the page. The system is also indicated for use following a stroke or with MS and Transverse Myelitis

What if I have been advised that my leg muscles are denervated?

If the injury level is such that your leg muscles appear to be denervated, we may have other technology and approaches that can help. With clients that have partial denervation, it may, with persistence be possible to develop a strong enough response to allow an FES Cycle to be used. When muscles are completely denervated we have technology developed in Austria especially for this situation. Please ask about the “Stimulette den2x”

I use a ventilator - does this prevent me from using an FES Bike?

RehaMove One - with arm training accessory

We now have some experience working with clients who use a ventilator. First check with your spinal injuries consultant to get approval to try our system. At the first few sessions we may wish to monitor blood pressure and heart rate responses to exercise.

Why should I use this equipment - after all it won’t cure my fundamental spinal problem?

Its important to recognise that this equipment can’t help repair the spinal cord. However, there are now clear benefits for overall health that will certainly help to ensure a user enjoys a better quality of life. Research into this shows that there are benefits to cardiovascular fitness and a range of other tangible health values (see below). Our clients report other benefits that are less easy to quantify by research - sleeping better, reduced difficulty with muscle spasm and simply “feeling better” Clients with other conditions should contact us for specific guidance.

Masters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434

Questions and Answers What support is there from the medical professions for FES Cycling?

You will find that medical reports are now increasingly advocating purchase of FES equipment as standard. Many spinal cord injury consultants advocate these systems but suitability will vary from person to person. You can ask us for guidance and you should always try a system before buying so that you can visualise how this equipment can fit into your life. Some of our clients will adopt the equipment following an insurance claim and others will use their own resources.

Is the system available on prescription?

Generally, the answer has been no. Although one client recently made a successful case to fund purchase via the NHS on the grounds that the RehaMove system would be a more cost-effective RehaBike way of managing troublesome muscle spasms than having a surgically implanted pump to delivery anti-spasm medication. Certainly exercise is effective in allowing a client to gain greater control of lower limb spasm and the practical evidence for this is quite good. Wider prescription of this technology is something we can hopefully look forward to in the future.

Can you help with an accident compensation claim?

Anatomical Concepts are not experts in this area but we do have a connection to many professionals who can advise on this area. They will often find ways of securing funds for essential equipment and resources in a manner that short-circuits the normal length delays for processing claims through the legal process. It is very important to take professional advice .

Is this therapy?

In some conditions using this technology is definitely of therapeutic benefit. We don’t just look on it this way though; as we have said above there are lots of health benefits because this is about getting exercise. Everybody needs exercise and this is especially true if spinal cord injury has reduced your capacity for this.

RehaMove with the new RehaStim 2 unit

What equipment choices do I have?

We now have two main versions of RehaMove.

- One allows active exercise of the legs - One allows active exercise of both the arms and legs for persons with arm and shoulder involvement.

We now offer these two main versions with a choice of stimulator design - RehaStim 1 or RehaStim 2.

RehaStim 1 has been tried and tested over 6 years in use around the world.

RehaStim 2 is a new stimulator design that has a contemporary appearance, offers the ability to record and store the settings for multiple users and provides additional performance feedback in a more pleasing graphical design. The technical function of RehaStim 1 and 2 remain fundamentally the same though.

There is also the RehaBike which is best suited for outdoor adventure with a trained “user.” With the RehaBike there is now a motor built-in to the system which can be engaged to take over if the stimulated muscles fatigue.

Masters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434

Questions and Answers Is there a version of the RehaMove for Children?

There is a Paediatric version with all of the features and benefits of the adult one. It is based on the Reck MOTOmed Gracile. The youngest client we have worked with has been just 4 years of age. The bike is fully adjustable to accommodate the child as he or she grows.

Are there upgrade possibilities?

Our system is modular and designed to be flexible. We have some users who started with a system for active leg exercise and then upgraded their system to include active arm exercise as well. This is quite a practical and economic thing to do it takes half an hour to add the arm accessories and perform any software upgrades.

An inexpensive software upgrade to RehaStim allows it to be used independently from the ergometer with powerful “Sequence mode” software.

Some hospitals use stand-alone FES muscle training in the EARLY STAGES of rehabilitation, before FES Cycling could commence. The beauty of our system is that by using our RehaStim unit from the beginning, the user can simply move to FES Cycling at the right time without needing to adopt new equipment.

Each RehaStim also has the possibility to be used with the RehaBike. The appropriate software can be uploaded to your RehaStim and then outdoor or indoor cycling is in your reach.

How many muscles can I exercise?

The stimulator supports 8 channels. This means you can exercise all the significant groups of muscles in the legs or the arms and shoulders typically these would be used as 4 muscle groups on the left and 4 on the right at a time. The RehaMove system is very powerful and flexible.

We set up some stimulation programmes for you that will quickly have you progressively exercising your muscles. You also learn how to modify and customise your own programmes using software “templates”.

We will advise you how to exercise and can even advise you on a personal trainer.

What do the systems cost?

Our prices are extremely competitive. A RehaMove 1 system for legs typically costs around £8000. The RehaMove system with RehaStim 2 is more expensive than with RehaStim 1 - around £8768. A combined arms and legs system typically costs around £9500.

We try to keep pricing simple - everything you need is generally included. There are no expensive extras or long term commitments other than electrodes. We include support sessions in these prices so that you are trained to use the system effectively. The aim is to create independence rather than dependance. Each system is fully guaranteed for the European standard warranty of two-years. We try to keep the price stable although currency exchange variations can effect price.

Prices may vary up or down depending on the exchange rate of the British Pound to the Euro. These prices would normally include a set-up and training session at home at your convenience plus a follow-up visit at around six weeks.

The RehaBike outdoor/indoor system based on the Haas Lepus trike is around £13,000 with a built-in “power assist” motor.

A version without the motor assistance but an adaptation to allow indoor training is priced at around £10,000.

I already have a Reck MOTOmed Viva2 - Can I upgrade to a RehaMove system?

The Reck MOTOmed is deservedly a very popular motion trainer. If you already have a Viva2 model we can upgrade your system to support FES. The Control/Display unit may need to be exchanged for one that has a “serial interface” to allow communication of the bike with the stimulator. Exact pricing depends on the age and condition of the Control/Display unit. We can supply the exchange Control/Display unit, the RehaStim unit in it’s travel case with accessories plus training and support. Please contact us for a quote - specify the serial number of your Viva2. NOTE. The RehaStim upgrade to a Viva2 is only available in the UK from Anatomical Concepts (UK) Ltd.

Masters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434

Questions and Answers What am I actually buying?

We feel that first and foremost you are buying a service. The equipment is just a part of that. This means that we try to keep pricing simple and as low as we can with everything you need included.

We won’t persuade you to purchase something just to make a sale - we want to feel that you will use this equipment. We want you to use the product for years and years so we take care that you are clear about its use and have you see that you can always count on us to support you. The equipment works if you do.

Each system comes with enough electrodes to see you through six months of normal usage and of course our warranty covers you for two years against defects of manufacture.

What ongoing costs are there?

Electrodes are the only consumable cost. Electrodes we provide are good quality, reusable ones that last between 15 and 25 sessions before replacement. Budget between £70 and £100 per year for these. They come in three different sizes - the smallest are most suitable for the arm and shoulder and the two larger sizes are often a matter of personal preference.

I can use my arms and shoulders - and I workout that way - why should I bother with FES Cycling?

It is excellent that you workout! Adding the large muscles of the legs into your exercise programme aids circulation and cardiovascular fitness as well as potentially reducing the risk of pressure sores. Working out sometimes with the legs helps to reduce the shoulder and neck problems that can arise through overloading these in the longer term. If you have issues with limb circulation or leg spasms you will find RehaMove helps deal with this very effectively for most people. And - Of course, it can also add an extra dimension to activity - particularly through the RehaBike which can take you outdoors.

What about FES Rowing?

This is great if you can do it. It puts a greater demand on your body which can be both good and bad. Not everyone can row - or wants to. If you’re interested in FES Rowing it is possible to equip a RehaStim unit with a triggering system and additional software. The flexibility of the RehaMove system means that you don't have to purchase an additional stimulator - you can add our optional software provided in the kit and this means you can go rowing very cost-effectively.

Who benefits from RehaMove?

We always ask our existing RehaMove clients for information on how they use their systems. Clients who responded to our questionnaire range in age between 21 and 46 years and had their accidents causing spinal injury between 12 months and 20 years ago. We asked for their motives in using a RehaMove system. All were interested in "reduced risk of pressure sores" and in "keeping fit in case of a cure". Doctor recommendation was much lower than we expected.

When it came to how often our clients exercised it was a nice surprise to find that 80% of our clients were exercising MORE than they expected to before purchasing a system. A few clients say they exercise every couple of days for more than an hour per session, but the majority aim to train three times per week with sessions varying from 20 to 40 minutes.

Why should I buy your system?

Best value for money, knowledgeable and dependable support. We don’ t create a dependency with our products that means you have to keep paying and paying .. and paying. Make your own comparisons.

Can I get a home demonstration?

We are happy to do this. Depending on where you live we might make a charge to do this depending on where you are and what we agree. We think it is important that you try the equipment and we have always been able to achieve this.

A home demonstration will typically involve a visit of around one and a half hours - we show you how the system works, setup the system for you to use, and typically you will work through a thirty minute exercise session and we answer any questions you might have. We would like you to be pretty knowledgeable about the background and the costs before we visit you. This is why we will provide you with lots of information up front.

Masters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434

Questions and Answers What about ongoing support?

We have partnership arrangements with some of the top specialist therapy groups in the country. They use our RehaMove systems and their therapists are trained to provide ongoing support if you need it. The majority of our clients are content with the two visits we make as part of our standard product pricing. If they want more our aim has always been to try to provide local and therefore cost-effective support to clients. We believe the most effective support is face to face and we normally would have physiotherapists or sports therapists to guide you when the need is for ongoing coaching. When you need technical support we provide the means for you to get this via phone, web or email.

Our partners?

• Prime Physiotherapy Ltd, 5 Beech House Melbourn Science Park, Cambridge Road, Melbourn, SG8 6EE T: 01763 264135; E: info@primephysio.co.uk; W: http://primephysio.co.uk/ • Standing Start, 10 South Cambridge Business Park, Sawston, Cambridgeshire, CB22 3JH T: 01223839055; E: info@standingstart.org; W: http://http://www.standingstart.org • More Rehab, PO Box 4726, Sheffield, S17 3BY T: 0114 2353150; E: info@morerehab.com; W: http://morerehab.com • Physiofunction, 50 High Street, Long Buckby, Northants NN6 7RD T: 0800 043 0327; E: rehab@physiofunction.co.uk; W: http://www.physiofunction.co.uk Do you have your equipment in the Spinal Units?

We have been working with this equipment since Spring 2006 and so it is relatively new on the UK market. The Scottish National Spinal Injuries Unit in Glasgow has both the RehaMove and RehaBike available for routine and research use. You will find the system in private units such as Standing Start and Prime Physiotherapy in the Cambridge area Physiofunction in the Midlands, More Rehab in Sheffield and the North and Physability in Stroud. Our approach with all professional colleagues is to seek collaboration and close working arrangements of mutual benefit. We are open to helping Units and their staff further develop and extend their expertise in this area. All Units should know about all the available systems and any strengths and weaknesses because they have a clinical imperative to act always in the best interests of their patients.

Can I speak to an existing client?

We have clients all over the UK and we will encourage you to ask our existing clients about us and the equipment. Just ask.

Is the equipment easy to use?

The equipment evolved from research and has many powerful features. This has two consequences. First of all - We as a company need to train and encourage you to learn how to use the system properly. That’s our responsibility. Look on us as your personal trainers. Secondly - the system has features that you might never need but they are there just in case. If you really think about it, its just the same with lots of commercial software. When was the last time you used all of the features in your Microsoft Word software? It can look like a lot to learn at first. However, we trust you and show you how to use this all effectively. It really doesn’t need someone looking over your shoulders all the time.

How do I get support?

Every client has access to multiple support possibilities. You will have access to your client manager - the person that dealt with you from the beginning - setting up and installing and maybe training you. We aim to develop fescycling.com as a resource for routine guidance and support. There are web-based training materials and videos. And of course, you can call our offices at all times for support. We have other exciting plans that will ensure that you get the most out of your investment.

Does the system need maintenance?

In an institutional setting we generally expect to work with that organisation via a contract to ensure that the system is inspected regularly because of the likely high frequency of usage. For home users we suggest that the stimulator unit is returned to us after two years for routine safety testing. There are no particular maintenance requirements other than folMasters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434

Questions and Answers lowing our guidance on keeping the equipment clean. Care needs to be taken with the electrode cables to keep them clear of the cycle pedals.

About Anatomical Concepts (UK) Ltd Established in 1996, Anatomical Concepts (UK) Ltd designs, develops and distributes innovative and clinically effective healthcare solutions. Based in Clydebank Scotland, we work with distribution partners throughout Europe and directly with hospitals, other care providers and private individuals to improve the quality of life of people affected by conditions such as stroke, diabetes, spinal cord injury, arthritis and multiple sclerosis. The company works closely with clinicians such as orthotists, surgeons, therapists, podiatrists and nurse specialists to ensure that our products are effective and refined in practice. We are represented at conferences and seminars around the world and recognised for our own research and educational expertise. With respect to FES Cycling, Anatomical Concepts represents the products of Hasomed GmbH, based in Magdeburg, Germany. The Scottish Spinal Injuries Unit introduced Anatomical Concepts to Hasomed to lead the commercialisation of the products.

Our websites http://fescycling.com - FES Cycling http://anatomicalconcepts.com - Corporate and orthotics http://rehacom.co.uk - RehaCom software for cognitive rehabilitation http://armexerciser.com - For arm rehabilitation following a stroke or brain injury http://issuu.com/anatomicalconcepts - Our documents site

Masters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434

Questions and Answers Can I use FES Cycling?

Almost certainly if you have a spinal cord injury with an intact lower motor neuron.

Whether sensory complete or sensory incomplete Best chance between C5 & T9

Absolute Contraindications?

Cardiac pacemaker Unhealed fractures in the lower-extremities to be stimulated Pregnancy

Relative Contraindications?

Denervated muscles

Benefits of FES Cycling Improved cardiovascular health Increased muscle bulk in the muscles of the legs Increased bone density in the lower limbs Reduction of spasticity Lowered risk of pressure sores.

Cosmetic benefits Improved feelings of wellbeing

Severe osteoporosis or >5 years since injury Damaged skin or open wounds in the stimulation current path Metal implants underneath the areas to be stimulated

Cautions for users with..

Uncontrolled autonomic dysreflexia History of lower-limb fractures or joint injuries

Programmable for effective exercise by the user Performance feedback Software allows use by persons with sensory complete or incomplete lesions Arm training accessories & software available.

Features of RehaBike Outdoor usage Uses the same stimulator as RehaMove Currently requires a “trained” user

Severe spasticity LImited ranges of joint motion at knee or hip - preventing cycling action

Features of RehaMove 8 channel stimulation of lower extremities

How do I receive the benefits?

Commit to regular exercise Ideally build up and maintain active exercise sessions of one hour 3 times per week or 40 minutes 5 times per week.

The system works if you do!

Ongoing costs?

Electrodes need to be replaced. Each reusable electrode may last 15-20 sessions. Each system comes with enough for 6 months typical usage.

Maintenance is minimal - we recommend a safety check every 2 years.

For insurance purposes we recommend a replacement life cycle of 3 years. The equipment should function well beyond this but it is likely that advances in technology make replacement advantageous in the way you may replace a car or a computer.

Warranty?

The manufacturers warranty covers you against all defects of manufacture or assembly for a period of 2 years

Suspected or diagnosed epilepsy Cardio-vascular diseases; Tumours; suspected or diagnosed heart problems Implanted medical devices

Masters of Rehabilitation Engineering anatomicalconcepts.com - info@anatomicalconcepts.com 8-10 Dunrobin Court, Clydebank G81 2QP Scotland t: +44(0)141-952-2323 f:+44(0)141-952-3434