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Guide for Prospective Clients support balance fitness health freedom

ERGOMETER TRAINING FOR LEGS AND ARMS COMBINED WITH FUNCTIONAL ELECTRICAL STIMULATION (FES) This document is a guide to FES Cycling and exercise using the Hasomed range of products. See also the following documents • Training Guide • Facts about RehaMove • FES Questions and Answers • Why exercise in paraplegia • New approach to tailored exercise - Multiple Sclerosis Version 6.1 January 2009

What’s New • RehaMove available for active upper extremity exercise as well as leg cycling. • An extended data analysis accessory is available. • Sequence Mode Software option allows new muscle training options PLUS the ability to use the stimulator unit independent of the ergometer Innovative, clinically effective, healthcare solutions www.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


Guide for Prospective Clients Introduction When I completed my PhD back in 1976, functional electrical stimulation (FES ) was an active area of research that never quite seemed to transfer into the world outside of the clinic. We aim to change all of that. Anatomical Concepts (UK), is a Scottish-based company with an eleven-year track record of working with innovative health care products. In particular we have always tried to be close to the real clinical issues and offer high quality products that make a difference. The health service needs products and services to be effective and good value for money and we treat this seriously. We are very pleased to be working with Hasomed GmbH, developers of this new technology and to be helping them to bring their very special products to the UK. Hasomed have collaborated with researchers at the Universities of Glasgow and Magdeburg to produce these systems and have created high quality products at extremely competitive prices. Although the products featured only illustrate leg training, we do have clients who would like to exercise arms and shoulders too. Please contact us if you would like more information about upper-extremity training. These products include systems that allow practical exercise for spinal cord injured people using FES. This technology employs sophisticated control ideas to allow each user to develop and sustain cardiovascular fitness. We are increasingly finding that many of our referrals are coming from Spinal Injury Consultants - perhaps one day everyone who could benefit from our systems would receive one via a prescription. We hope and expect that people will benefit from these products at home and in leisure centres around the world. We are approaching this area knowing that there are still things to learn - and there will never be a perfect product. Our hope is that we can play a significant role in generating progress that will benefit many people. Our aim is to provide the training and support that will ensure that people can use these systems with confidence. We hope that this note will lead you into a clearer understanding of FES Cycling and the RehaMove, RehaStim and RehaBike products in particular – when you are ready give us a call and take the next steps. Yours sincerely

Derek Jones Ph.D., M.B.A. Director Anatomical Concepts (UK) Ltd 8-10 Dunrobin Court Clydebank Business Park Clydebank Scotland G81 2QP T: 0141-952-2323 W: www.fescycling.com W: www.anatomicalconcepts.com

Innovative, clinically effective, healthcare solutions www.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


Guide for Prospective Clients 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

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Guide for Prospective Clients RehaMove - Leg training version

RehaMove - Arm and Leg training version

RehaStim - the heart of RehaMove

RehaStim - Extended Application

RehaBike

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Guide for Prospective Clients Quick Summary The benefits of cycling exercise therapy with Functional Electrical Stimulation are as follows: • • • • • • • •

Training the cardio-pulmonary system for improved fitness Rebuilding leg muscle strength and bulk Improvement of bone density in the legs Improvement of blood circulation and therefore reduced risk of bedsores (Decubitus ulcer) Improvement of intestinal and bladder function Improvement of responsiveness to insulin (for those with diabetes) Decreases in limb spasticity Improved feelings of well-being

Remember that if you have an opportunity to use this equipment early in the rehabilitation process please do so. These benefits are important.

Functional Electrical Stimulation (FES) is a useful therapy in many cerebral motor lesions of the lower limbs including Paraplegia/ Spinal Cord Injury and Stroke. It is a precondition for effective usage that the user has an intact lower motor neuron and can tolerate the stimulation without discomfort. It should not be used with individuals • • • • •

Who use a cardiac pacemaker With allergies against surface electrodes (irritation caused by exposure to the gel) Who are pregnant Diagnosed with epilepsy Potential clients with past episodes of autonomic dysreflexia in their medical history must consult their spinal injuries consultant before using an system.

Our product RehaStim can be used: - in combination with a stationary motion trainer, which is called RehaMove (see www.rehamove.de) - in combination with a recumbent tricycle, which is called RehaBike (see www.rehabike.de) - or as a standalone stimulator for general applications

Only a knowledgeable doctor or other clinician with specialised knowledge, can give medical advice on whether FES can be helpful for an individual. A separate guide is available for Clinical Advisors on request In Appendix A we have drafted a letter that could be used to assist insurance reimbursement claims. Technical Features of RehaStim

• • • •

Duration of the stimulation impulses (pulse width) 20μs to 500μs Maximum current - 135 mA Number of channels - 2 banks of 4 channels - 8 independent channels Stimulation frequency - 20Hz to 50Hz

How long does the treatment take?

Please Remember - this is not a treatment but rather a part of daily life. This technology assists a client to exercise and receive fitness benefits that are otherwise not available. Experience suggests that an exercise pattern of three to five times per week of up to one hour per session can be used to obtain greatest benefit. A frequency of three times per week will maintain benefits. Innovative, clinically effective, healthcare solutions www.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


Guide for Prospective Clients Table of Contents General Introduction.......................................................................................................... 1 Indications for Usage......................................................................................................... 1 BeneďŹ ts.................................................................................................................................... 2 User Assessment Considerations................................................................................... 2 Contra-indications---------------------------------------------------------- 2 What Muscles Can the Client Exercise?-------------------------------- 4 Suggested Pattern of Usage---------------------------------------------- 4 The User Manual------------------------------------------------------------- 4 Maintenance------------------------------------------------------------------ 4

Why do I need it?................................................................................................................. 5 Home Trial............................................................................................................................... 5 RehaMove Systems............................................................................................................. 6 Rehamove system - legs only-------------------------------------------- 6 Rehamove system - ARMS and legs------------------------------------ 7 Accessories-------------------------------------------------------------------- 8 Adding a RehaMove Controller to an existing ergometer-------- 9 RehaBike----------------------------------------------------------------------- 10

Demonstration Centre....................................................................................................... 11 Code of Practice................................................................................................................... 11 Contact Information........................................................................................................... 11 APPENDIX A........................................................................................................................... 12 DRAFT LETTER OF MEDICAL NECESSITY-------------------------------12 References-------------------------------------------------------------------- 13

Related Research Bibliography....................................................................................... 14

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Guide for Prospective Clients General Introduction We know that for good health we all need adequate exercise and this is normally difficult if not impossible for individuals following a spinal cord injury. However, if exercise could become possible, those with spinal cord injury potentially have a lot to gain. The function of the RehaMove system is to allow such individuals to operate a stationary cycle (a motorised ergometer) with their own muscle power. There are now two fundamental versions of RehaMove Version 1 - Allowing active exercise of the legs Version 2 - Allowing active exercise of the arms and legs (not simultaneously) Version 2 is most suited for those with a higher level of spinal cord injury where the muscles of the arm and shoulder are affected.

With a low-cost software addition, the RehaStim component can now be used free from the stimulator. This is useful for starting training before someone is ready for FES Cycling and also for stimulating muscles such as the abdominals. We know that in order to have a beneficial effect on the bones, muscles and cardiovascular system, exercise should involve working the larger muscles of the body against some form of resistance. The RehaMove system is an easy, effective and safe way of activating these leg or arm muscles and achieving exercise related health benefits.

Who may use FES? In general, persons who fulfill all the following requirements: • Only upper motor neuron lesions. • Joints that can move throughout the range needed for cycling • Skin sensation that can tolerate surface electrodes. • No abnormalities in x-ray of legs. • Good general health. • Emotionally stable and realistic

Sticky pads (electrodes) are placed over specific muscles. A sophisticated control system delivers stimulation to the muscles of the leg in the right sequence to develop muscle power over time. At the push of a button the ergometer starts to rotate, the system detects the position of the crank arms, calculates the time at which each muscle needs to be stimulated and sends the correct stimulation impulses to the electrodes. Thus it creates a fluent cycling or arm cranking movement.

Many spinal injuries consultants are now knowledgeable about FES Cycling and are recommending its use with their clients when indicated

Over time, as the condition of the muscles improves, they take a greater share of the effort required to work against resistance - producing a training effect. The system senses the contribution that a users muscles can make from moment to moment and adjusts how hard the user is working – making up the difference with motor power.

Indications for Usage The RehaMove System is applicable to spinal cord injured persons with complete or incomplete lesions where the lower motor neurons are still intact. Spasticity in the limbs is generally managed by the system, which automatically senses and adapts to the onset of muscle spasm in the lower limbs during use. Some contraindications and cautions are pointed out below.

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Guide for Prospective Clients To use the system effectively it is necessary that the user, perhaps if necessary with the support of a helper, can place electrodes correctly, position a wheelchair or appropriate seating system close to the motion trainer and secure the feet within the motion trainer pedals. Note: Other conditions such as stroke and multiple sclerosis may also be indications for use of the RehaMove. Although the principles still apply these indications are covered in separate documents.

Benefits Research suggests that the benefits that can come from using the RehaMove system are • • • • • • •

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 well-being

See bibliography in Appendix B and in particular the work of Hunt and colleagues at the University of Glasgow Hunt and Donaldson (2006) – “Regular clinical measurements during the 1- year cycle-training programme showed important improvements in cardiopulmonary fitness, bone density, and muscle bulk and strength”

User Assessment Considerations In choosing to work with the RehaMove system there are potential risks as well as benefits for a user. A detailed document exploring of this topic is available for consultation by your medical advisors if necessary. Functional Electrical Stimulation (FES) is a treatment modality that has been available in a research environment for many years and is at last benefiting individuals in their home environments. Improvements in the reliability and inherent safety of stimulation systems such as the RehaMove have meant that most people can safely use these systems. However, I guess that you and I would believe it to be a good idea to consult a doctor prior to commencing to exercise if we been inactive for a while. This is also appropriate for spinal cord injured people. You may find that your GP will not be knowledgeable about FES for spinal cord injury because, after all, it is a specialised area. We recommend you discuss your individual situation with your spinal injuries consultant or perhaps the physiotherapist who worked with you during your rehabilitation. If they too need further information about our technology we are happy to provide this. We are finding that many spinal injuries consultants are now knowledgeable about FES Cycling and are recommending its use with their clients when indicated. If consultation suggests that exercise with FES would be beneficial, it is nevertheless important to proceed carefully and increase the intensity of exercise gradually. In some situations there are clear contraindications to using RehaMove and these are highlighted below. In other situations the level of risk is less clear-cut and competent individuals, in consultation with the prospective user, should determine whether or how, it is safe to proceed.

CONTRA-INDICATIONS As with any exercise programming, certain precautions must be adhered to. Those most specific to individuals with spinal cord injury are described below. FES and the RehaMove should not be used by people • Who use cardiac pacemakers Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients • With epilepsy • With known allergies to electrode gel • With metal implants underneath or near the muscle groups which are to be stimulated. Pregnant women should desist from using stimulation because the possible adverse effects are unknown and have not yet been rigorously investigated. Individuals who have experienced autonomic dysreflexia should consult their usual doctor or ideally their spinal injuries consultant before commencing to use the system. If the prospective client can recognise the signs of this condition in themselves, and understand how to manage it, then this need not be a barrier to using a system. Autonomic Dysreflexia is a complication that occurs in people having sustained injuries at the 6th thoracic level and above. Generally, it is brought on by a stimulus that prior to the injury would have been recognized as uncomfortable. Due to limited communication between the injured spinal cord and brain, many individuals are unable to identify and respond to “uncomfortable” stimuli. As a result, blood pressure, heart rate and an overall sense of well-being becomes disrupted. The changes in blood pressure and heart rate may be life threatening if not responded to appropriately. It is imperative that the signs and symptoms of autonomic dysreflexia are understood by all involved prior to beginning an exercise program.

People injured more than 5 years ago may need special assessment before starting an exercise program. They can have a large loss of muscle mass, contractures, and brittle bones. People over 40 years of age may need additional evaluation for possible heart problems. People with the following conditions are disqualified: • History of leg fractures. • Severe spasticity. (as we will discuss below, moderate spasticity is often helped by this exercise) • Contractures that are severe enough to prevent cycling motion of the legs. • Severe osteoporosis (thin, weakened bones). One major effect spinal cord injury has on circulation is that of lowered blood pressure (hypotension). This may be of great concern during exercise participation as individuals may feel faint or dizzy. Low blood pressure, which occurs as a result of positional changes, is called orthostatic hypotension. Proper hydration, changing positions slowly and wearing compression stockings can be effective in avoiding orthostatic hypotension. You and I know there are many facets to wellness. Staying well involves a commitment to a healthy lifestyle. Exercise is one vital component, which if properly carried out can enhance the functional capacity of an individual who has sustained a spinal cord injury. It also can promote self-esteem and well being. Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients In conjunction with an exercise program, dietary habits involving good nutrition and proper hydration are essential. It is best to consult with qualified personnel regarding dietary concerns.

WHAT MUSCLES CAN THE CLIENT EXERCISE? A typical RehaMove user will wish to exercise the

• Quadriceps (on top of the thighs to extend the knee) • Hamstrings (below the thighs to flex the knee) And probably the

• Gluteal muscles (hip extensor muscles) • Calves (back of the leg) –or the Pre-tibial muscles (front of the leg) For arm training we typically use • Biceps - that bend the arm • Triceps - that extend the arm The flexibility of the system is such that other muscles can be activated when required. Note – It takes time to affix the electrodes. It may take 10 minutes at first but becomes less with practice. Ensure that clothing used during an exercise session is appropriate and allows ready access to the electrode sites.

SUGGESTED PATTERN OF USAGE Experience suggests that an exercise pattern of three to five times per week of up to one hour per session can be used to obtain greatest benefit. A frequency of two to three times per week will maintain benefits. Shorter sessions of 15 to 20 minutes are better than marathons. Please remember that it is necessary to have rest as well as exercise to progressively develop fitness.

You want to exercise arms and shoulders? This is now possible with an adaptation to the motion trainer. You would be able to actively train arms and shoulders on some days and legs on others. Contact us for more information.

We produce a detailed Guide to Training. This gives some background information and explains in detail how to set the system parameters so the user can optimise the benefits and customise the system for their use.

THE USER MANUAL The document provided with each system contains detailed instructions for usage and includes other information on user safety and precautions. This should be consulted to ensure that the user is familiar with the safety features built into the system and the methods of obtaining the best training results.

MAINTENANCE Maintenance requirements are normally minimal. To clean the stimulator only use agents intended for cold disinfection. Smooth plastic parts of the housing can be cleaned with a cloth rinsed with a normal detergent and a minimal amount of water. The manufacturer recommends the stimulation component of the system is returned for a safety check every two years.

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Guide for Prospective Clients Why do I need it? Well this document has already given you food for thought. It’s important to grasp that this is not a cure for the paralysis or sensory loss that results from spinal cord injury. What research is showing is that FES Cycling will benefit your health in a number of ways. Cardiovascular health is very important and using this technology gives you the means to get the same physical benefit that regular jogging brings to those who indulge in it.

Timing? - Research has shown that benefits are easiest to achieve when FES Cycling starts soon after an injury. If you are being advised on a long term rehabilitation strategy we suggest that you make FES Cycling a step you take as soon as possible.

Many of our clients want to keep fit because they believe that one day a practical cure for their condition will exist and they want to be fit enough to take advantage of this. No one can advise you with confidence on the timescale for this happening. Motivation? - In society all too many of us buy books and never finish them, buy consumer goods and never use them - please remember that committing to purchase this technology is not enough - you have to use it regularly and then you receive the benefit. To assist you to keep motivated and exercise we will continue to develop a specialised web site at

www.fescycling.com You can contact other users and support each other as well as receive support from our company. Overtime, this will become a source of information and a valuable source of knowledge to prospective users. If you would like a password for this system, prospective users can have access for one-month just contact us If on-line is not for you - Please contact us if you would like to speak to an existing user and get their views and experiences with the system

Home Demonstration A home demonstration is advised. There are some conditions. We would also expect you to have asked for medical advice on the risks and benefits that apply to you. We would quote you an amount to conduct the home trial. The amount will be based on the costs to us that would be involved in travel to your location. We would normally expect a physiotherapist or a similar health care professional to be present for this trial if you normally require such support. A home demonstration will explore in detail how the system works and how to use it safely and effectively. The user will learn how to apply electrodes, set up the system and conduct an exercise session. The whole session may take 1 to 2 hours. On purchasing a system a further visit may be required to ensure that each user’s system is set-up correctly and the user and/or carer comfortable with its operation. Let’s examine the specific systems now in more detail.

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Guide for Prospective Clients RehaMove Systems There are a few possibilities. 1. A complete RehaMove system for legs only 2. A complete RehaMove system for both legs and arms 3. Adding a RehaMove Controller to an existing motorised ergometer 4. A RehaBike system for outdoor use Additional accessories are available.

REHAMOVE SYSTEM - LEGS ONLY The system consists of the following components • Motorised ergometer/motion trainer • RehaStim Unit for Functional Electrical Stimulation of up to 8 muscle groups • Integrated software – RehaMove cycling software • Optional - Sequence mode software • Inputs for RehaMove and RehaBike • USB port for connection to PC • Power supply unit for RehaStim • Four pieces electrode cables – each cable for two muscle channels • 16 pieces electrodes • 1 data cable for software updates • 1 emergency off button • 1 connection cable between motion trainer and stimulator • 1 rack with bolt to fix the stimulator to the motion trainer • 1 transport case for RehaStim unit, power supply, cables and electrodes • User Manual • Commissioning visit at client location – training in system usage normally 1 – 2 hours. • Access to private RehaMove User Community website to connect with company and other users • Telephone support • Two year – return to manufacturer - warranty We normally recommend and supply a Reck MOTOmed Viva 2 leg training unit as part of the RehaMove system Note: we cannot supply an Ergometer alone

Order Code System A Configuration - FES 00050 - RehaMove System (Reck MOTOmed)

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Guide for Prospective Clients REHAMOVE SYSTEM - ARMS AND LEGS The system consists of the following components • Motorised ergometer/motion trainer • Additional “arm cranking” accessory allows active/passive exercise of the arms • “Standard” handles for arm exercise - See Accessories. • RehaStim Unit for Functional Electrical Stimulation of up to 8 muscle groups • Integrated software – RehaMove cycling software • Integrated software - RehaMove arm exercise software • Optional - Sequence Mode Software • Symmetry display for arm training (shows power generated by left and right arms) • Inputs for RehaMove and RehaBike • USB port for connection to PC • Power supply unit for RehaStim • Four pieces electrode cables – each cable for two muscle channels • 16 pieces electrodes • 1 data cable for software updates • 1 emergency off button • 1 connection cable between motion trainer and stimulator • 1 rack with bolt to fix the stimulator to the motion trainer • 1 transport case for RehaStim unit, power supply, cables and electrodes • User Manual • Commissioning visit at client location – training in system usage normally 1 – 2 hours. • Access to private RehaMove User Community website to connect with company and other users • Telephone support • Two year – return to manufacturer - warranty We normally recommend and supply a Reck MOTOmed Viva 2 leg training unit as part of the RehaMove system Note: we cannot supply an Ergometer alone Order Code

System C Configuration - RehaMove System (Reck MOTOmed) Arms & legs training

Arm Accessory rotates out of the way for leg training

One of the arm positioning choices

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Guide for Prospective Clients ACCESSORIES We have a number of accessories that may be desirable in some situations. In general we offer systems that consist of everything you need - these keeps pricing clear. You don’t want to be forced to by costly accessories that you will never need - we don’t wish to offer them. These are the most frequently desired accessories.

Height Adjustment System When a user is quite tall and/or they use a sports wheelchair or chair with a fixed footboard, it is important to check that the ergometer pedals are well clear of the wheelchair frame during normal cycling motion. We verify whether it is needed at an assessment visit. The height adjustment frame lifts and tilts the ergometer allowing easy access. The ability to easily wheel the system around is retained. Order Code FES00365 - Height Adjustment frame

Training Analysis System This new option allows your exercise performance to be recorded to a “Smart Card” and then analysed using easy to use software. This system can be specified as part of a new arm or leg training system, or added later to an existing RehaMove system. The Smart Card is placed in a slot on the ergometers controller and can record around 100 exercise sessions. The system is ideal for the motivated user - OR for institutions that wish to have multiple users of one RehaMove system. Order Code FES00356 - SAM1 training analysis programme - Can also as an upgrade to an existing system

be supplied

Forearm Shells/Hand Grips A variety of options are available to assist a client who wishes to exercise the arms but cannot use the “standard” handles. Please Ask for Details

RehaStim - Sequence Mode Software This is a new, recommended option for the RehaStim component of your FES Cycling system. This low-cost software addition allows the stimulator unit to be used independently from the rest of the Cycling system. Our users, may for example, choose to stimulate abdominal or other leg muscles whilst they relax. Order Code FES00605 - Sequence mode software upgrade

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Guide for Prospective Clients ADDING A REHAMOVE CONTROLLER TO AN EXISTING ERGOMETER Some individuals are already using a passive ergometer to maintain range of motion in the knees and hips. If you already have a Reck MOTOmed or a Medica TheraVital motion trainer it may be possible to add FES to your existing unit. (If you have another motion trainer type please contact us). Please tell us the exact model name and identifying details together with the unit serial number. The RehaStim system we would provide is connected by a single cable to your motion trainer. With some models of the Reck MOTOmed it will be necessary to replace part of the system with the RehaMove Cockpit (see below) to allow communication between the units. The software provided with the RehaStim unit must be compatible with your motion trainer. The RehaMove Controller (RehaStim) system consists of the following components • RehaStim Unit for Functional Electrical Stimulation of up to 8 muscle groups • Integrated software – RehaMove cycling software • Inputs for RehaMove and RehaBike • USB port for connection to PC • Power supply unit for RehaStim • 4 pieces electrode cables – each cable for two muscle channels • 16 pieces electrodes • 1 data cable for software updates • 1 emergency off button • 1 connection cable between motion trainer and stimulator • 1 rack with bolt to fix the stimulator to the motion trainer • 1 transport case for RehaStim unit, power supply, cables and electrodes • User Manual • Commissioning visit at client location – training in system usage normally 1 – 2 hours. • Access to private RehaMove User Community website to connect with company and other users • Two year – return to manufacturer – warranty (Motion Trainer warranty not included) Order • • •

Codes FES 00042- RehaMove Controller for TheraVital Motion Trainer FES 00052- RehaMove Controller for Reck MOTOMed Motion Trainer FES 00060- RehaMove Cockpit – required for some versions of the MOTOMed Motion trainer - Note this is an exchange component and price varies – please ask for an individual quote.

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Guide for Prospective Clients REHABIKE RehaBike offers people affected by paralysis a higher quality of life through physical exercise during an activity which is fun! See a Video (German soundtrack) in the Video Gallery on our web- site at www.anatomicalconcepts.com or www.fescycling.com The idea - and a great deal of research - has been undertaken by Professor K. Hunt and his team at the University of Glasgow. This idea has been developed and refined by Hasomed into the product we can offer you today. The RehaBike consists of a specially equipped, high-quality recumbent tricycle together with the RehaStim stimulator. The user sitting on the tricycle is protected by seatbelts and purpose-built orthoses support the user’s legs. Self-adhesive electrodes are fixed to the skin of the thighs and connected to the stimulator just as with the RehaMove. The stimulator has a special software program for cycling. The necessary parameters such as stimulation frequency and strength are easily adjusted. The individual parameters for each user can be saved. Cycling starts at the push of a button. The cyclist uses a “throttle” to control the stimulation intensity and thus the speed of the RehaBike. Sensors in each crank continuously tell the stimulator about the position of the cyclist’s legs. Microcomputers calculate at what time each muscle needs to be stimulated and send exactly the stimulation impulses necessary to the electrodes on the legs. Thus they create a fluent pedaling movement. Regular exercise of this kind improves the cyclist’s strength and endurance.

RehaBike - Want to use your own trike? We may be able to add FES to your trike - Ask for further information.

RehaStim contains rechargeable batteries that allow independent cycling for several hours. This system is more demanding to use and is recommended for people who have experience with the RehaMove system and have developed strength in the legs as a result. For those wet or winter days when outside use is not possible an adaption is available so that the RehaBike can be used indoors. Note: that the space requirement is higher than the RehaMove for indoor use. Order • • •

Code FES 00020 - Complete RehaBike sytem based on Model “Lepus” by Hase Bike FES 00305 – Tracx Ergotrainer allows indoor training with RehaBike FES 00306 – Custom leg positioning orthoses (pair) Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients Demonstration Centre Our UK demonstration centre is: The Queen Elizabeth National Spinal Injuries Centre (QENSIU) Southern General Hospital 1345 Govan Road Glasgow G51 4TF Tel: +44(0)141-201-2555 At the Centre are both RehaMove and RehaBike systems. These systems are available for trial by those with spinal cord injury. Write to the Clinical Director, or to our office in the first instance. PLEASE don’t turn up without asking in advance. In August 2008 a new research facility was established within QENSIU. The new research mezzanine, supported by the activities of the Scottish Centre for Innovation in Spinal Cord Injury, represents a unique research environment embedded within the clinical service. This opens a new chapter in human spinal cord injury research, and will add an important dimension to the comprehensive care package available to people in Scotland living with spinal cord injury. Professor Kenneth J Hunt FRSE, Director of Research Mr David Allan FRCS, Director QENSIU

Code of Practice Please Note: As members of the BHTA (British Healthcare Trades Association) we follow their strict “Code of Practice.” This is intended to ensure that we provide a fair and robust service to our clients. If you would like to view this Code of Practice you can download it from the BHTA website at the following link http://www.bhta.net/mainnav/code_of_practice/index.html

Contact Information Anatomical Concepts (UK) Ltd 8-10 Dunrobin Court Clydebank Business Park Clydebank G81 2QP Scotland T: +44(0)141-952-2323 F: +44(0)141-952-3434 Web: www.anatomicalconcepts.com Email: info@anatomicalconcepts.com FES USER COMMUNITY www.fescycling.com Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients APPENDIX A DRAFT LETTER OF MEDICAL NECESSITY <DATE> Re:

<NAME>

DOB:

<BIRTH DATE>

To Whom It May Concern: <NAME> is a <AGE> year old <male/female> under my care with <LEVEL> paraplegia ASIA <GRADE>. Prior to <his/her> injury, <NAME> was an active and healthy individual. Due to <his/her> spinal cord injury-induced mobility limitation, <NAME> needs to undertake an alternative form of movement to maintain physical integrity and to minimize concomitant medical complications which have serious health consequences and can be costly to resolve. Based on the level and nature of the injury, our experience indicates that <NAME> would benefit from a continued program of lower extremity <and OR > upper extremity exercise and movement utilizing a functional electrical stimulation (FES) leg-cycle ergometry system. Once a patient has sustained a spinal cord injury and is stabilized, lower extremity mobilization can be achieved by use of a leg-cycle ergometer powered by their own muscle strength, albeit not under voluntary control, but powered by FES. Benefits have been researched and reported on the effects of leg-cycle ergometry with FES for individuals with a spinal cord injury. A summary of these is provided below. Muscle atrophy effects Increases in the muscle cross sectional area 1,2 Increases in lean body mass with a decrease in the whole body fat content 1,2 Increases in voluntary and electrically induced muscle contraction 1,2 Increases in muscle endurance 3,4 Cardiovascular effects Improvements in the body’s utilization of oxygen (energy expenditure) 7-13 Improvements in heart rate, stroke volume, and cardiac output during exercise and at rest indicating a pronounced effect on cardiovascular health.14 Spasticity effects FES cycling with a large number of repetitions (greater than 1500 per week) lead to significant positive changes in spasticity. 15,16 Range of Motion Increases in knee joint range of motion17 The goal for <NAME> is to be able to achieve and maintain these benefits. As a result, based on <NAME>’s needs, I am recommending a daily home therapy program utilizing <FES-induced> leg-cycle ergometry. Thank you for your attention to this matter. __________________________ <PHYSICIAN>, <TITLE>, <CLINIC>, <ADDRESS>

Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients REFERENCES 1. Scremin AM, Kurta L, Gentili A, Wiseman B, Perell K, Kunkel C et al. Increasing muscle mass in spinal cord injured persons with a functional electrical stimulation exercise program. Arch Phys Med Rehabil 1999; 80(12):1531-1536. 2. Hjeltnes N, Aksnes AK, Birkeland KI, Johansen J, Lannem A, Wallberg-Henriksson H. Improved body composition after 8 wk of electrically stimulated leg cycling in tetraplegic patients. Am J Physiol 1997; 273(3 Pt 2):R1072-R1079. 3. Chilibeck PD, Jeon J, Weiss C, Bell G, Burnham R. Histochemical changes in muscle of individuals with spinal cord injury following functional electrical stimulated exercise training. Spinal Cord 1999; 37(4):264-268. 4. Mohr T, Andersen JL, Biering-Sorensen F, Galbo H, Bangsbo J, Wagner A et al. Long-term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord 1997; 35(1):1-16. 5. Belanger M, Stein RB, Wheeler GD, Gordon T, Leduc B. Electrical stimulation: can it increase muscle strength and reverse osteopenia in spinal cord injured individuals? Arch Phys Med Rehabil 2000; 81(8):1090-1098. 6. McDonald JW, Becker D, Sadowsky CL, Jane JA, Sr., Conturo TE, Schultz LM. Late recovery following spinal cord injury. Case report and review of the literature. J Neurosurg 2002; 97(2 Suppl):252-265. 7. Bhambhani Y, Tuchak C, Burnham R, Jeon J, Maikala R. Quadriceps muscle deoxygenation during functional electrical stimulation in adults with spinal cord injury. Spinal Cord 2000; 38(10):630-638. 8. Raymond J, Davis GM, Climstein M, Sutton JR. Cardiorespiratory responses to arm cranking and electrical stimulation leg cycling in people with paraplegia. Med Sci Sports Exerc 1999; 31(6):822-828. 9. Hooker SP, Scremin AM, Mutton DL, Kunkel CF, Cagle G. Peak and submaximal physiologic responses following electrical stimulation leg cycle ergometer training. J Rehabil Res Dev 1995; 32(4):361-366. 10. Hooker SP, Figoni SF, Rodgers MM, Glaser RM, Mathews T, Suryaprasad AG et al. Physiologic effects of electrical stimulation leg cycle exercise training in spinal cord injured persons. Arch Phys Med Rehabil 1992; 73(5):470-476. 11. Hooker SP, Figoni SF, Glaser RM, Rodgers MM, Ezenwa BN, Faghri PD. Physiologic responses to prolonged electrically stimulated leg-cycle exercise in the spinal cord injured. Arch Phys Med Rehabil 1990; 71(11):863-869. 12. Mutton DL, Scremin AM, Barstow TJ, Scott MD, Kunkel CF, Cagle TG. Physiologic responses during functional electrical stimulation leg cycling and hybrid exercise in spinal cord injured subjects. Arch Phys Med Rehabil 1997; 78(7):712-718. 13. Ragnarsson KT. Physiologic effects of functional electrical stimulation-induced exercises in spinal cordinjured individuals. Clin Orthop 1988;(233):53-63. 14. Faghri PD, Glaser RM, Figoni SF. Functional electrical stimulation leg cycle ergometer exercise: training effects on cardiorespiratory responses of spinal cord injured subjects at rest and during submaximal exercise. Arch Phys Med Rehabil 1992; 73(11):1085-1093. 15. Skold C, Lonn L, Harms-Ringdahl K, Hultling C, Levi R, Nash M et al. Effects of functional electrical stimulation training for six months on body composition and spasticity in motor complete tetraplegic spinal cordinjured individuals. J Rehabil Med 2002; 34(1):25-32. 16. Jacob PL, Nash MS. Modes, benefits and risks of voluntary and electrically induced exercise in persons with spinal cord injury. J Spinal Cord Medicine 2001; 24(1):10-18. 17. Bremner LA, Sloane KE, Day RE, Scull ER, Auckland T. A clinical exercise system for paraplegic using functional electrical stimulation. Paraplegia,30:647-655. Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients Related Research Bibliography Hunt, K.J; Donaldson, N (2006) Final Report, EPSRC Grants GR/R92462 (Glasgow) and GR/R93520 (UCL) “The Development of Systems for Paraplegic Cycling: improving health after spinal cord injury” Prof. K. J. Hunt, Centre for Rehabilitation Engineering, Mechanical Engineering, University of Glasgow and Prof. N. Donaldson, Implanted Devices Group, Medical Physics and Bioengineering, University College London November 2006 Baldi, J.C.; Jackson, R.D.; Moraille, R. & Mysiw, W.J. (1998), 'Muscle atrophy is prevented in patients with acute spinal cord injury using functional electrical stimulation.', Spinal Cord 36(7), 463--469. Barstow, T.J.; Scremin, A.M.; Mutton, D.L.; Kunkel, C.F.; Cagle, T.G. & Whipp, B.J. (1996), 'Changes in gas exchange kinetics with training in patients with spinal cord injury.', Med Sci Sports Exerc 28(10), 1221--1228. Bhambhani, Y.; Tuchak, C.; Burnham, R.; Jeon, J. & Maikala, R. (2000), 'Quadriceps muscle deoxygenation during functional electrical stimulation in adults with spinal cord injury.', Spinal Cord 38(10), 630--638. Chilibeck, P.D.; Jeon, J.; Weiss, C.; Bell, G. & Burnham, R. (1999), 'Histochemical changes in muscle of individuals with spinal cord injury following functional electrical stimulated exercise training.', Spinal Cord 37(4), 264--268. * Demchak, T.J.; Linderman, J.K.; Mysiw, W.J.; Jackson, R.; Suun, J. & Devon, S.T. (2005), 'Effects of Functional Electric Stimulation Cycle Ergometry Training on Lower Limb Musculature in Acute SCI Individuals', Journal of Sports Science and Medicine 4, 263--271. Eser, P.; de Bruin, E.D.; Telley, I.; Lechner, H.E.; Knecht, H. & St|ssi, E. (2003), 'Effect of electrical stimulation-induced cycling on bone mineral density in spinal cord-injured patients.', Eur J Clin Invest 33(5), 412--419. Eser, P.C.; de N Donaldson, N.; Knecht, H. & St|ssi, E. (2003), 'Influence of different stimulation frequencies on power output and fatigue during FES-cycling in recently injured

SCI people.', IEEE Trans Neural Syst Rehabil Eng 11(3), 236-240. Faghri, P.D.; Glaser, R.M. & Figoni, S.F. (1992), 'Functional electrical stimulation leg cycle ergometer exercise: training effects on cardiorespiratory responses of spinal cord injured subjects at rest and during submaximal exercise.', Arch Phys Med Rehabil 73(11), 1085--1093. Figoni, S.F. (1990), 'Perspectives on cardiovascular fitness and SCI.', J Am Paraplegia Soc 13(4), 63--71. Figoni, S.F.; Rodgers, M.M.; Glaser, R.M.; Hooker, S.P.; Feghri, P.D.; Ezenwa, B.N.; Mathews, T.; Suryaprasad, A.G. & Gupta, S.C. (1990), 'Physiologic responses of paraplegics and quadriplegics to passive and active leg cycle ergometry.', J Am Paraplegia Soc 13(3), 33--39. Fitzwater, R. (2002), 'A personal user's view of functional electrical stimulation cycling.', Artif Organs 26(3), 284--286. Fornusek, C. & Davis, G.M. (2004), 'Maximizing muscle force via low-cadence functional electrical stimulation cycling.', J Rehabil Med 36(5), 232--237. Gerrits, H.L.; de Haan, A.; Sargeant, A.J.; Dallmeijer, A. & Hopman, M.T. (2000), 'Altered contractile properties of the quadriceps muscle in people with spinal cord injury following functional electrical stimulated cycle training.', Spinal Cord 38(4), 214--223. Gerrits, H.L.; de Haan, A.; Sargeant, A.J.; van Langen, H. & Hopman, M.T. (2001), 'Peripheral vascular changes after electrically stimulated cycle training in people with spinal cord injury.', Arch Phys Med Rehabil 82(6), 832--839. Hooker, S.P.; Figoni, S.F.; Rodgers, M.M.; Glaser, R.M.; Mathews, T.; Suryaprasad, A.G. & Gupta, S.C. (1992), 'Physiologic effects of electrical stimulation leg cycle exercise training in spinal cord injured persons.', Arch Phys Med Rehabil 73(5), 470--476. Hooker, S.P.; Scremin, A.M.; Mutton, D.L.; Kunkel, C.F. & Cagle, G. (1995), 'Peak and submaximal physiologic responses following electrical stimulation leg cycle ergometer training.', J Rehabil Res Dev 32(4), 361--366.

Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients * Janssen, T.; Glaser, R. & Shuster, D. (1998), 'Clinical efficacy of electrical stimulation exercise training: effects on health, fitness, and function', Topics in Spinal Cord Injury Rehabilitation 3(3), 33-49. Kjaer, M.; Perko, G.; Secher, N.H.; Boushel, R.; Beyer, N.; Pollack, S.; Horn, A.; Fernandes, A.; Mohr, T. & Lewis, S.F. (1994), 'Cardiovascular and ventilatory responses to electrically induced cycling with complete epidural anaesthesia in humans.', Acta Physiol Scand 151(2), 199--207. Kjaer, M.; Pollack, S.F.; Mohr, T.; Weiss, H.; Gleim, G.W.; Bach, F.W.; Nicolaisen, T.; Galbo, H. & Ragnarsson, K.T. (1996), 'Regulation of glucose turnover and hormonal responses during electrical cycling in tetraplegic humans.', Am J Physiol 271(1 Pt 2), R191--R199. Leeds, E.M.; Klose, K.J.; Ganz, W.; Serafini, A. & Green, B.A. (1990), 'Bone mineral density after bicycle ergometry training.', Arch Phys Med Rehabil 71(3), 207--209. Mohr, T. (2000), '[Electric stimulation in muscle training of the lower extremities in persons with spinal cord injuries]', Ugeskr Laeger 162(15), 2190--2194. Mohr, T.; Dela, F.; Handberg, A.; Biering-Sxrensen, F.; Galbo, H. & Kjaer, M. (2001), 'Insulin action and long-term electrically induced training in individuals with spinal cord injuries.', Med Sci Sports Exerc 33(8), 1247--1252. Mohr, T.; Podenphant, J.; Biering-Sorensen, F.; Galbo, H.; Thamsborg, G. & Kjaer, M. (1997), 'Increased bone mineral density after prolonged electrically induced cycle training of paralyzed limbs in spinal cord injured man.', Calcif Tissue Int 61(1), 22--25. Mutton, D.L.; Scremin, A.M.; Barstow, T.J.; Scott, M.D.; Kunkel, C.F. & Cagle, T.G. (1997), 'Physiologic responses during functional electrical stimulation leg cycling and hybrid exercise in spinal cord injured subjects.', Arch Phys Med Rehabil 78(7), 712--718. Perkins, T.A.; de N Donaldson, N.; Hatcher, N.A.C.; Swain, I.D. & Wood, D.E. (2002), 'Control of leg-powered paraplegic cycling using stimulation of the lumbo-sacral anterior spinal nerve roots.', IEEE Trans Neural Syst Rehabil Eng 10(3), 158--164.

Petrofsky, J.S. (2003), 'New algorithm to control a cycle ergometer using electrical stimulation.', Med Biol Eng Comput 41(1), 18--27. Petrofsky, J.S. & Laymon, M. (2004), 'The effect of previous weight training and concurrent weight training on endurance for functional electrical stimulation cycle ergometry.', Eur J Appl Physiol 91(4), 392--398. Petrofsky, J.S. & Stacy, R. (1992), 'The effect of training on endurance and the cardiovascular responses of individuals with paraplegia during dynamic exercise induced by functional electrical stimulation.', Eur J Appl Physiol Occup Physiol 64(6), 487--492. * Phillips, C. (1991), Functional Electrical Rehabilitation , Springer-Verlag , New-York . Raymond, J.; Davis, G.M. & van der Plas, M. (2002), 'Cardiovascular responses during submaximal electrical stimulation-induced leg cycling in individuals with paraplegia.', Clin Physiol Funct Imaging 22(2), 92--98. Raymond, J.; Schoneveld, K.; Kemenade, C.H.V. & Davis, G.M. (2002), 'Onset of electrical stimulation leg cycling in individuals with paraplegia.', Med Sci Sports Exerc 34(10), 1557--1562. Scremin, A.M.; Kurta, L.; Gentili, A.; Wiseman, B.; Perell, K.; Kunkel, C. & Scremin, O.U. (1999), 'Increasing muscle mass in spinal cord injured persons with a functional electrical stimulation exercise program.', Arch Phys Med Rehabil 80(12), 1531--1536. Skvld, C.; Lvnn, L.; Harms-Ringdahl, K.; Hultling, C.; Levi, R.; Nash, M. & Seiger, A. (2002), 'Effects of functional electrical stimulation training for six months on body composition and spasticity in motor complete tetraplegic spinal cordinjured individuals.', J Rehabil Med 34(1), 25--32. Theisen, D.; Fornusek, C.; Raymond, J. & Davis, G.M. (2002), 'External power output changes during prolonged cycling with electrical stimulation.', J Rehabil Med 34(4), 171--175. Thijssen, D.H.; Ellenkamp, R.; Smits, P. & Hopman, M.T. (2006), 'Rapid vascular adaptations to training and detraining in persons with spinal cord injury.', Arch Phys Med Rehabil 87(4), 474--481.

Innovative, clinically effective, healthcare solutions www.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

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Guide for Prospective Clients Thijssen, D.H.J.; Heesterbeek, P.; van Kuppevelt, D.J.M.; Duysens, J. & Hopman, M.T.E. (2005), 'Local vascular adaptations after hybrid training in spinal cord-injured subjects.', Med Sci Sports Exerc 37(7), 1112--1118.

* Wilder, R.P.; Jones, E.V.; Wind, T.C. & Edlich, R.F. (2002), 'Functional electrical stimulation cycle ergometer exercise for spinal cord injured patients.', J Long Term Eff Med Implants 12(3), 161--174.

Trumbower, R.D.; Karan, S.R. & Faghri, P.D. (2006), 'Identifying offline muscle strength profiles sufficient for shortduration fes-lce exercise: a pac learning model approach.', J Clin Monit Comput 20(3), 209--220.

Innovative, clinically effective, healthcare solutions www.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

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FES Cycling Guide  

A comprehensive guide document to the RehaMove FES Cycling product. Covering clinical and practical benefits and features