FES Newsletter

Winter 2000 / 2001

Editorial

Electrical stimulation and epilepsy

Equipment News

News from Birmingham

New Clinic at Queen Mary's Hospital, Roehampton

An investigation of the effect of functional electrical stimulation to assist the gait of children with cerebral palsy

A pilot study to inform sample –size calculations for an investigation into the effects of Electrical Stimulation on recover of hand sensation and function in stroke patients.

FES based training orthosis for hand function following stroke

Using FES in Shoulder Subluxation

IMPULSE Update

IMPULSE Questionnaire

Potential cost of falls with Stroke patients

Forthcoming Courses

Read all about it!

Functional Electrical Stimulation (FES) in Equinovarus Spasticity


Editorial

The FES (Functional Electrical Stimulation) Newsletter is a biannual publication with the purpose of promoting the clinical use of FES. It is distributed chiefly to clinicians who have attended the Salisbury introductory FES course but also those who have an interest in the field or those we hope may be interested.

Interest in FES and particularly for the FES course has continued to grow over the last six months. Last September we did our first overseas course, in Hornbeak, near Copenhagen and we are about to do our first course in the Irish Republic. September also saw the FES User day, which, despite the petrol blockades, was an enjoyable event with presentations on a variety of topics. Some abstracts from the meeting are included here. Also in this edition we have articles on the possible risk of using FES with patients who have epilepsy, the cost of falls to the NHS, a report on the questionnaire sent out with the last edition, up dates on R&D and the usual equipment news and lists of forthcoming courses. There is also news of a major multi centre trial looking at the cost benefit of the use of botulinum toxin and / or FES for correction of dropped foot. Please fill in the questionnaire to let the investigators know what you think of their plans and to register possible interest in being involved.

As always we welcome feed back and if you would like to use this newsletter to publicise your service, research or meeting please let us know. The next edition will be put together in July.

Paul Taylor

Department of Medical Physics and Biomedical Engineering,

Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ, UK

Tel: O1722 429 065, Fax: 01722 425 263

Email: p.taylor@salisburyfes.com

Web page: www.salisburyfes.com


Electrical stimulation and epilepsy

We have received some anecdotal reports of cases where the symptoms of epilepsy have been exacerbated by use of electrical stimulation. In all cases so far this has been related to upper limb exercise using FES and in most cases this has occurred in patients who are under treatment for epilepsy, which may not have been well controlled by drugs.

Only in one case did a fit occur in an individual who had no history of epilepsy. This occurred during a lecture when a student was asked to be a guinea pig to demonstrate electrical stimulation of wrist extension. After a few minutes of stimulation, the student had an apparent petit mal although this was not confirmed as the diagnosis. In two cases, patients have described the onset of a pre fit aura while performing upper limb exercises. When stimulation was stopped, the symptoms immediately subsided. One of the patients persisted with the use of electrical stimulation and became habituated to the effect and no longer experienced symptoms. There has been one other report of a patient who experienced an increased frequency of fitting after starting FES treatment. However it is not clear that this was directly related to the treatment.

It is not known what mechanism may be responsible for this apparent effect or even if it is directly due to the use of electrical stimulation or associated with other factors such as the stress associated with performing a new activity. Nevertheless, now that several incidents have been reported (4 from over 1000 subjects who have used FES in Salisbury) the possibility of affecting epilepsy should be taken into account when starting treatment with a new patient. As all patients who have suffered a stroke or traumatic brain injury are at greater risk of epilepsy, it is clear that this effect is experienced by only a small minority. We therefore recommend that epilepsy only be considered a contraindication to FES in non controlled epilepsy, and it is used with caution in cases where there is any doubt over the effectiveness of drug control. In all cases so far, the effect has occurred when treatment has begun or soon after. It is therefore likely that if problems do not occur at the first or second treatment session, then it would seem unlikely that they will occur at all.

The instruction manuals will be amended to include this warning in the section on precautions and contraindications.

If you have experienced any unusual effects following electrical stimulation treatments, please let us know. We will keep a record of these effects and if necessary pass the information on via this newsletter.

Paul Taylor


Equipment News

New leads

Recent directives from the Medical Devices Agency require that it should not be possible for the plug of an electrode lead to come into contact with any other device that may result in electricity passing to the wearer of the electrodes the lead is connected to. Apparently, there was a case some time ago, not in the UK, where a lead with a standard jack plug was accidentally put into a mains socket, causing the patient to receive a shock. While this would be impossible with UK electrical sockets, it is now necessary for the conducting parts of the connector to be shrouded in an insulator. From the spring of this year all new ODFS will be supplied with this form of connector. The other stimulators will be changed later in the year. It is still OK to continue to use the old equipment as the new rules only apply to new equipment purchased. The new leads are not compatible with the old ones. We will continue to supply spares of the old style.

Foot switch lead couplers

Users of the new foot switches, which were introduced last winter, have noticed that the connection between the foot switch and the foot switch lead can become loose after several months of use. We have recently obtained lead couplers from the manufacture. These are small plastic cuffs that fit around the plug and socket, making it harder to pull the connectors apart. If you would like try some of these devices please contact Stacey Finn 01722 429118.

Electrodes

Due to fierce competition in the electrode market, prices have fallen. We are pleased to pass these savings on to you. It is still a good idea to shop around so check other suppliers for better deals. Here is our new price list.

Order Code

Electrode Size/Type

1-9

£

10-29

£

30+

£

J10R00

 

25mm (1") Round. PALS Plus

 

5.08

 

4.83

 

4.59

879100

 

32mm (1 ¼") Round. PALS Plus

 

6.61

 

6.28

 

5.96

881150

 

38mm (1.5") Round. PALS Plus

 

6.70

 

6.70

 

6.70

879200

 

50mm (2") Round. PALS Plus

 

7.00

 

6.65

 

6.31

879300

 

70mm (3") Round. PALS Plus

 

8.81

 

8.36

 

7.95

891200

 

30X50mm (1¼"X2") Rectangular. Pals Plus

 

6.76

 

6.42

 

6.10

895220

 

50X50mm (2X2") Square. Pals Plus

 

6.61

 

5.28

 

5.96

901220

 

50X50mm (2X2") Square-Blue. PALS Plus Hypoallergenic

 

6.98

 

6.63

 

6.30

650/2578

 

46X46mm Square. Versa-Stim Electrodes

 

9.28

 

8.75

 

8.23

Our other prices remain the same. The new version of the ODFS will be supplied at the same price as the old version.

Stimulators

ODFS – Odstock Dropped Foot Stimulator £272.25

O2CHS – Odstock Two Channel Stimulator £379.00

O4CHS – Odstock 4 Channel exercise Stimulator £295.40

MS2 – Microstim 2 exercise stimulator £267.75

All stimulators are supplied with all accessories necessary for their use. They are guaranteed for one year. There is a 10% discount on orders of 5 or more stimulators.

Accessories

Electrode leads (1.0 or 1.5m) £8.90

Foot switch leads (60, 75, 100, 120 or 150 cm) £11.20

Double Foot Switch Leads £22.40

Other lead lengths are available on request

Foot switch £22.40

Double foot switch £34.70

Sounder £10

Wow pedal (for O4CHS) £75

Duracell Batteries (pack of 10) £15

2 NiMH Rechargeable Batteries with charger £25

When ordering please put you name on the order so we can check against our list of accredited users. Orders to Stacey Finn, Department of Medical Physics and biomedical Engineering, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ. Tel: 01722 429 118 Fax: 01722 425 263

 


News from Birmingham.

The FES Clinic at City Hospital, Birmingham has reached its 4th birthday and continues to go from strength to strength. With an average of 112 referrals per year from far and wide and 128 current users of FES equipment we are kept very busy. Funding remains a constant battle. However, with an eye to expansion I am in the process of setting up a FES Clinic at Oak Tree Lane Centre, Birmingham. This is a Regional Specialists Centre for Rehabilitation (Neurological & Amputee) and provides an opportunity to co-ordinate services such as FES, orthotists, botulinum toxin clinics and gait analysis. This represents a truly patient centred service and one that provides many opportunities for development. Watch this space!

I am also involved in setting up a pragmatic randomised clinical trial together with 3 neuro consultants and others (Salisbury included) looking at ODFS and botulinum toxin injection effectiveness on equinovarus spasticity with quality of life and health economic outcome measures. The trial will have 4 arms; placebo, placebo and FES, botulinum toxin alone and botulinum toxin with FES. It is hoped that MRC funding can be secured. The grant application has made it through the initial stages and has just one hurdle to pass, later this year. This is a large trial with 1000 patients and therefore needs to go nationally. A questionnaire is attached with this newsletter concerning the trial and it will be interesting to see what response we get. Any queries please contact christine.singleton@btinternet.com

Regards to all.

Christine Singleton

Clinical Specialist (FES)

Sheldon Centre, City Hospital, Dudley Road, Birmingham

 


New Clinic at Queen Mary's Hospital, Roehampton

Plans are well under way to start a new FES clinic at Queen Mary's Hospital Roehampton (South London) by Clinical Engineer Dr David Ewins and Physiotherapist Sally Durham. The team has extensive experience using FES with cerebral palsy children and will now take referrals for stroke, MS and SCI from the South East. It is hoped that the new service will begin in the next financial year. For more information contact David Ewins d.ewins@surrey.ac.uk

 


 

FES User Day Abstracts

An investigation of the effect of functional electrical stimulation to assist the gait of children with cerebral palsy

Sally Durham 1, Linda Eve 2, David Ewins 3

1 Paediatric Physiotherapy, Queen Mary’s Hospital, Roehampton, London

2 One Small Step Gait Laboratory, Guy’s Hospital, London

3 University of Surrey, Guildford, Surrey and Roehampton Rehabilitation Centre, Queen Mary’s Hospital, Roehampton, London

Functional Electrical Stimulation (used successfully for gait assistance in neurologically impaired adults) may be helpful for children with cerebral palsy who walk with a toe gait. However, there is conflict in the literature regarding the use of electrical stimulation in children with cerebral palsy. Some evidence supports the use of stimulation to the anterior tibial muscles, others support stimulation of the calf muscles.

Following a positive initial trial on four children, the investigators are extending the work to a pilot study. It is proposed to establish baseline data of the child’s usual walking and range of movement, using video and computer analysis in the gait laboratory. After repeating this at three months, this will be followed by electrical stimulation to the anterior tibial muscle group. Stimulation will be applied using the Odstock ODFS MKIII single channel stimulator. Data collection will be repeated once stimulation is set up and after three months. During this time the child will continue to receive their normal therapy as before. Three months after starting stimulation, use of the equipment will be suspended for a further three months, before repeating the data collection. The effectiveness of the stimulation will also be assessed by the use of a questionnaire to be completed by the child and their parent or guardian.

All of the twelve recruits have begun the first phase of data collection, and eleven have moved on to the second phase and have had their stimulators set up. Analysis will begin once we have complete sets of data. Subjective observations of the orthotic effect and acceptability so far are improvements in heel strike in gait, standing with flat feet, improved toe clearance during swing phase and increased stability (fewer falls). Patients have reported the equipment to be reliable, but large, heavy and lacking cosmesis, particularly with summer clothes.

The investigators are grateful to Remedi and the Special Trustees of the South West London Community Trust for funding this project.

 


A pilot study to inform sample –size calculations for an investigation into the effects of Electrical Stimulation on recover of hand sensation and function in stroke patients.

Geraldine Mann,1 Jane Burridge,2 Lisa Malone1

1Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury

2School of Health Professions and Rehabilitation, University of Southampton

At the Department of Medical Physics in Salisbury we are frequently asked by patients who have suffered a stroke to apply FES to the upper limb to improve function. We attempt to address individual problems such as increased spasticity, loss of range of movement, muscle weakness and loss of function with exercise stimulation, using anything from one to four channels of stimulation in varying combinations. Very little of this work has so far been documented or the effects of the treatment assessed. This has implications for the funding of patients for upper limb stimulation.

There are over 100,000 new strokes a year in the United Kingdom about half of whom have impaired function of the upper limb, and of these only 14% will regain any useful function. There is some published evidence of the efficacy of electrical stimulation in recovery of sensation and motor control of the hemiplegic upper limb, but little concerning its effect on return of useful, measurable function affecting activities of daily living. This study is being carried out in an attempt to add to the body of evidence concerning the efficacy of stimulation for the hemiplegic upper limb and to inform sample –size calculations for a larger trial.

Thirty patients are randomised into two groups, 15 receiving simultaneous stimulation to elbow, wrist and finger extensors and 15 in the control group, carrying out passive stretches to these muscle groups, incorporating active movement where possible. Participants are recruited for the study within a year following a first stroke resulting in hemiplegia. They have to be medically stable, have evidence of sensory impairment and be able to carry the hemiplegic hand towards the mouth. The same amount of time is spent on treatment by each group and subjects continue with their usual physiotherapy or occupational therapy.

Subjects are assessed using the Jebsen Hand Function Test, The Action Research Arm Test and two point discrimination for the hand, at weeks 0, 6, 12 and 24. Treatment is set up at week 0 and carried out twice a day for the first 12 weeks. Treatment is then stopped and the final assessment carried out at week 24. This is so that any carry over effect can be assessed.

Thirteen subjects have so far been recruited from Salisbury District Hospital and the stroke unit at Christchurch Hospital, Bournemouth, six in the stimulation group and seven controls. Although no – one has yet completed the full twenty four weeks programme, initial results show an encouraging greater improvement in function so far in those using stimulation compared to the control group. However, similar levels of change in sensation have not been not yet been evident in either group.

The investigators are grateful to the Physiotherapy Research Foundation for part funding this study.


FES based training orthosis for hand function following stroke

Paul Taylor, Paul Chappell*.

Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, * Department of Electrical Engineering, University of Southampton,

Introduction

Electrical stimulation exercises have been demonstrated to be beneficial in re-educating the ability to open the hand. However it has been suggested that if a functional aspect can be added to these exercises, the retraining effect could be improved. This paper describes a FES device designed to stimulate the radial nerve, producing a general extension pattern of the fingers, thumb and wrist, controlled by the weak EMG signal detected from the same wrist extensors. In this way, residual activity can be boosted, enabling the flexor spasticity to be overcome.

Method

The main problem in recording voluntary EMG from a stimulated is the stimulation artifact, which is of the order of 10,000 the level of the desired signal. This artifact will saturate any standard EMG amplifier. Secondly, following the stimulation pulse is the compound action potential or M wave due to the synchronous firing of motor units which is an order of magnitude greater than the voluntary EMG. Difficult problems are often best ignored, so in this case the artifact and M wave can be prevented from entering the system by disconnecting the front end amplifier for 15 - 20 ms following the stimulation pulse. In this period a sample and hold circuit is used to maintain the level of the signal to minimise variation due to the DC off set of the system. However, the instantaneous level of the signal from the front end amplifier is not the same at the end of the blanking period as at the beginning resulting in a step response followed by a decay curve due to the RC time constant of the sample and hold. This new artifact can again be removed by a second stage of blanking following the band pass and rectifier stages of the circuit. However, to effectively reduce the time period of the artifact the lower end of the pass band has the relatively high frequency of 200Hz. This leaves sufficient signal to produce an EMG envelope, which is used to control a modified Odstock Dropped Foot Stimulator. The stimulator's output can be either driven directly by the envelope producing an output proportional to the EMG envelope or used to trigger a fixed amplitude output for a fixed or adaptive (started and stopped by EMG) time.

Results

The system has been tried by three individuals who have had a stroke. It was found possible to detect EMG in the wrist extensors of all three subjects. However the effort of producing wrist extension had the effect of increasing the spastic tone in the flexor muscles of the hand, sometimes resulting in clawing of the fingers when the extensors were stimulated. This effect was greatest when proportional control was used, as it required the greatest effort by the user. All three subjects were able to use the system to open their hand to acquire objects such as a door handle or large objects such as food cans. Two of the three subjects used the device daily at home. Both reported that their hand felt more relaxed and that they felt more aware of their affected arm than before. However, no significant changes in hand function were recorded using the Jebsen Test.

There was some evidence that users of the EMG systems could learn to relax their muscles after some practice suggesting that using the device may help train self control of spasticity. Additionally, stretch reflexes induced in flexor muscles, being velocity dependent, could be reduced by using a slow rise in the stimulation amplitude to the extensor muscle. This was difficult to achieve using proportional control and slows down the response of the system. It was also observed that the stimulation it's self had an inhibiting effect on the voluntary EMG in normal subjects, effectively reducing the gain of the system as the contraction strength rose. This may be due to unloading of the Golgi tendon organs or shortening of the muscle spindles leading to an inhibition or reduction of drive to the a motor neurone. This affect has not yet been observed in stroke subjects but if present, it is not known what the implication of this effect would be for the re-education of movement.

Conclusion

This study has demonstrated that it is possible to control hand opening by EMG from the same muscles that are stimulated. However, the rise in spasticity that this some times caused may be detrimental, reinforcing undesired patterns of movement. Further work is required to better understand the neurological effects of this technique.


Using FES in Shoulder Subluxation

Salisbury District Hospital - Stacey Finn (Clinical Engineer)

Subluxation is a partial dislocation of the shoulder joint. In the early stages of stroke, there is often a period of initial flaccid paralysis. With the aid of gravity this flaccidity can lead to the downward displacement of the humeral head away from the scapular. As the only structures left to support the joint are the joint capsule and ligaments, pain often sets in. Of the 100,000+ stroke victims admitted to hospital each year in the U.K., as many as 80% of patients have been reported to show shoulder subluxation1, and up to 72% of patient have experienced shoulder pain at some stage2. Most studies conclude that shoulder pain is directly related to subluxation.

The traditional treatment for shoulder subluxation is some type of arm support or sling, leaving the arm, for large parts of the day, in a flexed and adducted position. Although slings can help reduce pain in the subluxed shoulder, this positioning can interfere with functional activities and may prevent the rehabilitation process. A review of literature on the subject showed how by using FES, a significant decrease in shoulder subluxation and pain can be achieved1,3,4,. Studies using FES also showed a significant increase in arm function and range of motion, shorter hospital stays and helps activities of daily living. Although these results look promising, no known device was available at the onset of my MSc project, dedicated to tackling the above problem.

A two-channel portable neuromuscular electrical stimulator was developed. The device is controlled by microprocessor controlled and includes a LCD (Liquid Crystal Display). All parameters such as frequency, pulse-width, on time and ramp rates are controlled by software and the output is pulse width modulated, providing comfortable and smooth muscle contractions. A program has also been written that counts and displays the number of hours and minutes the stimulator has been on. This information could be used to verify compliance in a clinical trial.

The stimulator was fitted to a patient diagnosed with subluxation of the shoulder. X-rays taken with and without stimulation showed a reduction in subluxation of 14mm using the device while the device was stimulating. A radiographer could see no anatomical difference between the results found using the device and that of a normal subject. After some further development we hope to conduct a clinical trial to demonstrate the long term benefit from using the device.

References

  1. Faghri P.D., Rodgers M.M., Glaser R.M., Bors J.G., Ho C., Akuthota P. (1994) The effects of functional electrical stimulation on shoulder subluxation, arm recovery, and shoulder pain in hemiplegic stroke patients, Archives of Physical Medicine and Rehabilitation, 75, 73-79.
  2. Roy C.W., Sands M.R., Hill L.D., et al. (1995) The effect of shoulder pain on the outcome of acute hemiplegia, Clinical Rehabilitation, 9, 21-27.
  3. Chantraine A., Baribeault A., Uebelhart D., Gremion G. (1999) Shoulder Pain and Dysfunction in Hemiplegia: Effects of Functional Electrical Stimulation, Archives of Physical Medicine and Rehabilitation, 80, 328-331.
  4. Linn S.L., Granat M.H., Lees K.R. (1999) Prevention of Shoulder Subluxation After Stroke With Electrical Stimulation, Stroke, 30, 963-968.

 


IMPULSE Update

(Improved Mobility through imPlanted fUnctional eLectrical Stimulation of nErves)

In last summers newsletter we told you about a new project starting in Salisbury to investigate the use of an implanted dropped foot stimulator, designed by the University of Twente in The Netherlands and the UK firm Finetech Medical. In brief the device has two channels of stimulation, one for each branch of the common peroneal nerve. In this way it is possible to control the amount of dorsiflexion and eversion separately. As with the ODFS timing is controlled using a foot switch in the shoe. A small box, held in place by a strap, placed over the implant transmits power and control signals to the implant using radio telemetry. The main advantage of the system is that electrodes do not need to be placed accurately each time it is used and there is no risk of skin reaction from electrodes.

The first two patients received the device in Holland last summer and were followed by two patients in Salisbury, December last year. The surgery in Salisbury was performed by Plastic Surgeon, John Hobby. The Dutch patients are using the devices daily and have improved their mobility considerably. Both Salisbury patients are now being trained to use the device and initial results are very promising. The device performs as predicted, correcting the dropped foot allowing a safer, faster and more energy efficient gait.

The project requires a further three candidates. If you know of any suitable candidates who live within commuting distance of Salisbury and are able to attend at least 15 times over 6 months we would be pleased to hear from you. We will send you an information pack that you can forward to your patient. If they are interested in taking part they can then contact us directly. Potential candidates must fit the following selection criteria:

  1. First hemiplegia as a result of a CVA of at least 12 months duration with a stable neurology.
  2. Dropped foot identified by an inability to achieve a normal heel strike during walking.
  3. Subject can walk with or without support (self selected gait speed using walking aid or orthosis in the range 0.1-0.6 m/s for at least 100m)
  4. Must be able to understand the use of the equipment and purpose of the trial.
  5. Able to give informed consent
  6. Subjects must be aged between 18 and 65 years

Exclusion criteria

  1. Evidence of inversion contractures;
  2. Serious medical conditions that would affect response to stimulation or implant procedure (cardio-vascular, respiratory or arthritic conditions, diabetes, pacemaker user)
  3. Serious psychological conditions, affecting ability to understand or fully comply with the conditions of the trial.
  4. Regular usage of a surface peroneal stimulator;

 


IMPULSE Questionnaire

In the last edition of the FES newsletter we sent out a questionnaire asking for your opinions of what you thought the problems with the ODFS were and whether you would consider using an implanted dropped foot stimulator.

Two hundred clinician questionnaires were sent out from which 39 replies were received. 33 were received from physiotherapists, 5 from biomedical engineers and one from a GP. Electrode positioning was thought to be a significant problem with 18% reporting this as a severe problem, 56% a moderate problem and 26% a slight problem. Problems with wires and foot switches and donning and doffing were considered of similar difficulty in both cases, 56% and 44% respectively considered them of moderate difficulty while 5% considered them severe problems in both cases. Skin problems and the sensation of electrical stimulation were not thought to be severe problems but recognised as moderate or slight. Only 1 clinician would consider the implant for all patients while 72% would consider it for long term users of the ODFS. 1 clinician would only consider an implant if use of the ODFS were prevented by the above problems and 2 only if an AFO did not give a viable alternative. One clinician would not consider an implant under any circumstance.

A similar questionnaire was sent out to 140 long term ODFS users of whom 98 replied. The average time the ODFS had been used for was 3.0 years with the maximum time used of 10 years. Overall satisfaction of ODFS use was high scoring a mean of 7.5 on the visual analogue scale (10 = very satisfied, 0 = very unsatisfied). 52% had good satisfaction with the ODFS while 41% were moderately satisfied. However problems were widely reported and only 13% reported they experienced no problems. The most commonly experienced problem was with finding electrode positions (72%) with 17% reporting these problems to be severe and 37% a moderate problem. The second most commonly reported problem was problems with wearing wires and foot switches (58%). While fewer severe problems were reported (9%), 31% reported moderate problems. The next most reported problem was related to the previous one, that of donning and doffing the equipment (47%). 15% thought this problem was severe and 20% felt it to be a moderate problem. 36% reported the sensation from the electrical stimulation to be a problem although only 3% felt it to be a severe problem and 15% a moderate problem. Finally, skin problems were reported by 28%, of which 6% felt they were severe, 12% moderate and 9% slight. In total 67% thought they would prefer to have an implant. This includes 7% who experienced no problems but presumably felt an implant would be more convenient to use.

It is interesting that problems have been more commonly reported in this study than the previous questionnaire, administered two years ago1. In that study incidence of problems was similar to only those reported as moderate or severe in this study. It is unlikely that problems are recurring more frequently now although the time experienced using the ODFS is greater than the previous study and therefore they had had more time to experience problems in. A more likely explanation is that while in the first study the users were just reporting on experience, in this study they are being asked to make a comparison with a possibly better system which might relieve some of the daily difficulty of using the ODFS. Either way it highlights the need for good patient education and continuing follow up.

Perhaps the most important statistic in this study is that the average period of ODFS use was 3.0 years with many users having used it for much longer. (The average drop out after 1 year of treatment is 14% including a few who give up because they no longer need the ODFS). This indicates that the ODFS addresses a significant problem that is significantly alleviated by its use. However the incidence of problems indicate that for many, some dedication is required to obtain this benefit. If these problems can be removed then life may be made easier for this patient group and improved mobility extended to wider population. Potential acceptance of an implant appears to be high with 67% of users saying they would prefer it and most clinicians considering it at least for some patients.

Reference

1. Taylor PN, Burridge JH, Dunkerley AL , Lamb A, Wood DE, Norton JA, Swain ID. Patient's Perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin. Rehab. 1999; 13: 333-340

Paul Taylor and Geraldine Mann

 


Potential cost of falls with Stroke patients

Patients who have had a stroke are at high risk of falling. In a study by Tutarrima(1) et al. the incidence of falls stroke patients while in rehabilitation was 8.9 / 1000 per day. They found that 25% of falls lead to injury which ranged from slight to severe while 2% of falls resulted in hip fractures. These injuries obviously have a significant impact on the health service. In a separate study, Rizzo(2) et al. showed that the impact of an average fall in the USA was $11,042 to the hospital while home nursing costs were $5,325 leading to a total cost of $19,440 (1996 prices). This does not include the impact on employment or on family members who have extra burden placed on them. While there is no objective direct evidence that use of a dropped foot stimulator reduces falls, Taylor(3) et al found in a questionnaire survey of users of the Odstock Dropped Foot Stimulator that 70% of users claimed that they used the device because they were less likely to trip. This is backed up by the observation by Granat(4) et al. that foot to floor contact was more reliable, correcting lateral border of the foot weight bearing in the early stance phase. This will lead to more stable gait, resulting in a reduced incidence of falls and a significant impact on costs to the NHS.

Potential cost saving to the NHS by reducing the number of falls

In order to calculate the cost benefit for the ODFS, values quoted in references 1-4 have been used:

Without any aid, 8.9/ 1000 patients have a fall each day, hence each patient falls 3.2 times per year. However, only 25% of these result in injury, which means that each patient injures themselves 0.8 times per year. An average cost to the NHS per fall is £13,000 (assuming the same cost as in the USA). Hence the total cost per patient per year is £10,368.

However, as the original fall data was from patients who were receiving inpatient rehabilitation following their stroke it is reasonable to assume that after that period falls would occur less frequently. Also not all patients would benefit from the device. Therefore the fall rate may be assumed to be one quarter of that stated leading to on average, one fall in which an injury occurs being experience once every five years. The cost per year would therefore be £2,592. This includes home care costs, which are not covered by the NHS. Excluding these the costs to the NHS will be approximately £1,472, or £1766 allowing for 20% inflation since 1996, which is 1.76 times the first year costs of the ODFS.

Therefore, it can be concluded on this analysis that the cost to the NHS in supplying stroke patients with the ODFS may be recovered in less than 8 months. After that there may be a significant financial benefit to the NHS of around £1,566 per year.

1. Tutuarima JA, van der Meulen JHP, de HaanRJ, Limburg M. (1997) Risk factors for falls of hospitalized stroke patients. Stroke 28(2):297-301, 1997 FEB

2. Rizzo JA, Friedkin R, Williams CS Nabors J, Acampora D Tinetti ME. Health care utilization and cost in a Medicare population by fall status. Medical Care 36(8):1174-88, 1998 Aug.

3. Taylor PN, Burridge JH, Dunkerley AL , Lamb A, Wood DE, Norton JA, Swain ID. Patient's Perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin. Rehab. 1999; 13: 333-340

4. Granat MH, Maxwell DJ, Fergusen ACB, Lees KR, Barbanel JC. Evaluation of common peroneal stimulation for the correction of dropped foot in hemiplegia. Archives of Physical Medicine and Rehabilitation. 1996;77:19-24

Paul Taylor

 


Forthcoming Courses

Before clinicians can prescribe the ODFS or O2CHS for their patients, they must attend a course. This is mandatory. Two courses are offered. The introductory course gives an introduction to FES and its application in neurorehabilitation. The course, which has a large practical content, is intended to enable clinicians to select candidates for the ODFS and to set the device up. An introduction to upper limb FES treatments is also given. The second course, intended for clinicians that have some experience of the ODFS, introduces the O2CHS. This device is allows the activation of a second muscle group in addition to common peroneal stimulation for correction of dropped foot. Common uses for the device includes bilateral dropped foot, dropped foot with hamstrings for improved knee flexion, dropped foot and glutes for hip extension in the stance phase and dropped foot and quads for weight bearing.


Introductory Courses

23rd-24th February 2001, Dublin. Contact Sonia Summers, Physiotherapy, Beaumont Hospital, Beaumont Road, Dublin, Republic of Ireland. . tel 00353 1 809 2535

23rd - 24th March 2001. Edinbough. Contact Caroline McGuire, Physiotherapy, Astley Ainlie Hospital, 133 Grange Loan, Edinburgh, EH9 2HL Tel. 0131 537 9000 or 0131 537 9161 Fax 0131 537 9151

6th-7th April 2001 Stanmore- London. Contact Sue Paddison, Spinal Unit Physiotherapy, Royal National Orthopedic Unit, Stanmore, Midlesex. tel 0208 954 2300

10th - 11th May 2001 Leeds. Contact Moira Keith, Chapel Allerton Hospital, Chapeltown Road, Leeds, LS7 4SA Contact Moira Keith 0113 392 4520/3

18th - 19th May 2001 Salisbury. Contact Alison Leighfield, Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ Tel. 01722 429045 Fax. 01722 425263

19th -20th July, Norwich. Contact Kath Vick Physiotherapy, Caroline House, Coleman Hospital, Unthank Road, Norwich, Norfolk, NR2 2TJ, Tel 01603 288 985

 

2 Channel Courses

29th - 30th March 2001, Salisbury. Contact Alison Leighfield, Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ. Tel. 01722 429045 Fax. 01722 425263

If you would like a course to be held at your own hospital, please contact Alison Leighfield 01722 429045


Read all about it!

Did you know that this edition of the Salisbury FES Newsletter and all back issues can be viewed on our website: www.salisburyfes.com When the next newsletter is published it will also be available by email. We hope this will have several advantages: guaranteed delivery (even if your postal address changes), reduced paper use, and easy ‘forwarding’ to other interested people. It will also allow a wider audience to read the newsletter.

If you would like to receive the next newsletter by email then please email to let me know.

Philip Wright

(P.Wright@Salisburyfes.com)


 

 

 

 

FUNCTIONAL ELECTRICAL STIMULATION (FES) IN EQUINOVARUS SPASTICITY

Confidential survey of current practice

Name: ……………………………………………………………….……………………………

Hospital: ……………………………………………………………….……………………………

Address: ……………………………………………………………….……………………………

……………………………………………………………….……………………………

……………………………………………………………….……………………………

Speciality (Please circle) Physiotherapist Other (specify ……………..…………)

Subspecialty (Please circle) Neurosciences Orthopaedics Paediatrics Other (specify ……..…………………)

Grade (Please circle) Senior I Senior II Rotational

Functional Electrical Stimulation Section

Have you ever trained to use FES for equinovarus spasticity (spastic footdrop)? (Please circle) YES or NO

Do you have funding to treat patients with FES for equinovarus spasticity? (Please circle) YES or NO

How many patients with equinovarus spasticity on average

do you treat with FES each year? …………………. per annum

Where did you or your team learn this technique? ……………………………….

Do you use the Odstock (Salisbury) Dropped Foot Stimulator? (Please circle) YES or NO

How long do you provide FES treatment before attempting withdrawal? ………………….. months

Prospective Trial

We are designing a large pragmatic trial of Botulinum toxin (BTX) and functional electrical stimulation (FES) in acquired unilateral equinovarus spasticity. This will be a UK-wide multicentre trial in which patients will be randomised to placebo, BTX, FES, or BTX and FES in a 2 x 2 factorial design. BTX will be administered at baseline, 3 and 6 months and patients followed to 12 months. FES will continue throughout. The primary outcome measures will be quality of life and health economics.

Do you consider a study of BTX for this indication is required? (Please circle) YES or NO

Do you consider a study of FES for this indication is required? (Please circle) YES or NO

Do you consider a study of combined BTX and FES for this indication is required? (Please circle) YES or NO

Would you be interested in participating in such a trial? YES or NO

Please feel free to comment on your response:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

 

Thank you for sparing the time to complete this survey.

Please return to: University of Birmingham Clinical Trials Unit

Park Grange

1 Somerset Road

Edgbaston

Birmingham B15 2RR


home frame