FES Newsletter

Summer 2000

Editorial

Royal College of Physicians - The National Clinical Guidelines for Stroke

Meeting Review – IFESS 2000 Aalborg University, Denmark.

The efficacy of Functional Electrical Stimulation in improving walking ability for people with Multiple Sclerosis

Initial experience in the use of Functional Electrical Stimulation in a variety of neurological conditions resulting in facial palsy

Electrical stimulation of abdominal muscles for control of blood pressure and assisted cough in a C4 level tetraplegic.

Equipment News

Forthcoming Courses, lectures and Meetings

O.D.F.S and 2-Channel Nominated for Nye Bevan Award

IMPULSE

Meeting Review - Introduction to the Neuro Control StIM System

Book Review Neuro Muscular Electrical Stimulation. A Practical Guide. 4th Edition

Current price list

IMPULSE QUESTIONNAIRE


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.

In this issue we have reviews of the IFESS (International FES Society) Conference and we have included three extended abstracts which were presented by the Salisbury team at the meeting. There is a review of Neuro Control’s meeting introducing the StIM System, a percutaneous stimulator for the correction of shoulder subluxation. There is a questionnaire which we ask all our readers to complete which seeks to find out the clinical acceptability of an implanted dropped foot stimulator.

Back additions of the FES Newsletter can be found on our web page: www.mpbe-sdh.demon.co.uk

Paul Taylor


Royal College of Physicians

The National Clinical Guidelines for Stroke

The RCP have brought out guidelines for the treatment of stroke which they describe as follows:

"The National Clinical Guidelines for Stroke sets out clearly and unequivocally the minimum basic standards for care based on graded evidence. The Guidelines have been compiled by the multidisciplinary Intercollegiate Stroke Working Party and have been extensively peer reviewed. Each aspect of stroke care covered includes main guidelines, extensive evidence on which they are based and suggestions for the development of local guidelines. Patients' and carers' observations, based on their first hand experiences of stroke care, have been incorporated throughout the text."

Included in the section on rehabilitation is a section on FES, recommending its use for correction of dropped foot and reduction of the pain associated with subluxed shoulder. The use of electrical stimulation to improve hand function is also reviewed but no recommendations made.

An extensive reference section provides a valuable source for evidence based practice that would be a valuable resource for any researcher in the field of stroke.

Copies of the report can be obtained from: Publications Department, Royal College of Physicians of London, 11 St Andrews Place, Regent’s Park, London, NW1 4LE price £22 including P&P. Alternately the document can be viewed on the RCP web page www.rcplondon.ac.uk (linked from our web page)

Paul Taylor


Meeting Review – IFESS 2000

Aalborg University, Denmark.

This was the 5th annual conference of the International FES society and was attended by 300 delegates from more than 25 countries. This record attendance reflects the growing interest in the field of FES. With over 150 presentations and posters it is impossible in this review to cover the whole conference. I will therefore restrict this report to clinical or near clinical applications. The conference was dominated by developments in implanted systems and techniques for their control. There was also a bias towards systems aimed at spinal cord injury.

After a welcome by the conference host Thomas Sinkjaer of the Centre for Sensory-Motor Interaction, Aalborg University, the first session was on clinical and therapeutic FES. This included a presentation of the CREST project from Malcolm Granat of Strathclyde University. This system uses skin surface electrode stimulation to improve the gait of incomplete spinal cord injured marginal walkers, set up with the aid of basic gait analysis system. A novel aspect of the system is that it allows communication between centres so gait information and stimulator settings can be shared and expert advice sought from more experienced centres. Assessments included walking speed, ankle, knee and hip angle while walking, foot fall data using foot switches, observational gait analysis and video. About half used single channel stimulators for correction of dropped foot (ODFS), the others using mostly two channels of stimulation adding quads, gluteus maximus or bilateral dropped foot (O2CHS or their own three channel CREST Stimulator). Timing of the stimulation was by foot switch or hand switch. The system was used in centres in Denmark, Holland, Spain and the UK and was successful in improving the gait of 34 subjects.

Also presented in this session and later demonstrated in the University lab tour was an implanted dropped foot stimulator from the Aalborg group. M. Haugland presented the system which uses a multi pole cuff electrode surgically placed around the common peroneal nerve above the knee. From anatomical dissection it has been shown that the parts of the nerve that are responsible for dorsiflexion and eversion lie on opposite sides of the nerve. It is therefore possible by selecting electrodes on the cuff to selectively control these movements. Initially the electrode cuff is implanted and connected via percutaneous leads to an external stimulator. The best combination of electrodes is then selected by trial and error and when found a second operation is used to implant a 2 channel implanted stimulator. Power and control signals are passed to the implant by radio telemetry and the stimulation timed using a foot switch. Three stroke subjects have received the device, two of whom demonstrated the device in the lab tour. In effect the correction was similar to that obtained by skin surface electrodes. However, both users of the system said they preferred it to the surface systems as there was no sensation and there was no difficulty finding the electrode positions. The second subject had a variation of the system, where the signal from the sural nerve which caries sensory information from lateral side of the sole of the foot was detected. This indicated when the foot was on the ground. Using fuzzy logic the stimulator was controlled enabling the subject to walk bare foot. While the latter system works well the external parts of the system have not yet been miniaturised to enable home use.

The concept of using natural sensors was also demonstrated in a second application from the Aalborg group. In a modification of the Neuro Control Freehand System (an implanted FES system for tetraplegic hand function) a C5 SCI subject had a sensory electrode placed on the cutaneous nerve that comes from the radial aspect of the index finger. The signal is used to feed back to the stimulator detecting when an object begins to slip from the users grasp. The amplitude to the stimulation is then increased to maintain the grasp. The practical implication of this is that the user dose not need to grip with maximal strength at all times to ensure grip is maintained which is beneficial in minimising muscle fatigue. The system has performed well in the lab and home trials are planed soon.

From Queen’s University in Kingston, Ontario came a presentation on the use of BIONs for the correction of shoulder subluxation. BIONs are injectable micro stimulators. They are encapsulated in glass tubes 16mm long and 2mm in diameter. The active and indifferent electrodes are at either end of the device. Power and control signals are passed through the skin using radio telemetry and digital encoding allows several BIONs to be individually activated. Under local anaesthetic, the stimulation site is first found using a needle with a stimulating electrode at its tip inside a 12 gauge lumen. When the correct movement is observed, the needle is withdrawn and the BION inserted using a plunger. Tests have shown that the devices do not migrate in the body. In this application BIONs are placed in the middle deltoid and supraspinatus. Exercises are performed at home for 6 weeks. Initial results show that the system is well accepted and there is little sensation from the device. There was a significant reduction in subluxation and some improvement in voluntary activity. Alfred E. Mann Foundation, the company distributing the BIONs, is looking for UK centres wishing to participate in trials of the device. For more information contact Yitzhak Zilberman. PO Box 905, Santa Clarita, CA 91380 USA e-mail - yitzhakz@aemf.org

Three Implanted systems for standing and other functions in paraplegia were presented. The first, the Praxis24-FES system is an adaptation of a cochlea implant from Australia. Eight electrodes are placed epimysially on muscles while ten nerves are stimulated using nerve cuff electrodes to produce standing. Three additional channels are used for sacral anterior root stimulation to control the bladder. Closed loop control is used to maintain knee extension using the Andrews ground reaction orthosis. By maintaining the ankles with some plantarflexion, the body’s centre of gravity is placed in front of the knee enabling knee extension to be maintained without stimulation of the quadriceps. If the knees do begin to buckle, this is detected by knee goniometers, which turns the stimulation on to restore knee extension. Standing times of up to 70 minutes have been recorded. Recent work has replaced the goniometers with accelerometers, which gives a faster response. Two subjects have received the system.

The second implant system presented was from Cleveland Ohio and is an adaptation of the Neuro Control Freehand System (for tetraplegic hand function) and is known as the Free Stand System. As this system has passed all the regulatory process for its use in tetraplegia, it is attractive to use it for this secondary purpose. The intention of the system is that it will allow standing and be used to assist standing transfers. Six epimysial electrodes are placed bilaterally on gluteus maximus, semimembranous and vastus lateralis. The remaining two electrodes were intramuscular electrodes and were placed next to the nerve roots of L1/2 in order to excite the lumbar erector spinae. 7 subjects with lesions from T9 to C6 have received the system. Maximum standing times of between 2 and 20 minutes have been reported with all but one subject able to stand with one hand removed from the support for a short time. Six subjects have also performed standing transfers. Improvements in the ischial skin blood flow were also recorded indicating improved resistance to pressure sores. Initial indications are that the users are satisfied with the system and use it regularly at home.

The third implant was reported by the SUAW (Stand Up And Walk) European project. This purpose built implant from France also uses a mixture of nerve cuff and epimysial electrodes for twelve muscles. The presentation was restricted to a technical description of their implant. However, the device has been implemented in one individual who has achieved standing and taken a few steps.

Some interesting work was presented which investigated the mechanism behind the short term carry over effect commonly seen after using a peroneal nerve stimulator. Using motor evoked potentials elicited using magnetic cortical stimulation, the Aalborg group demonstrated that threshold for evoking a motor response in anterior tibialis was reduced after thirty minutes of common peroneal stimulation, indicating that the motor cortex became more excitable. This effect was maintained for upto thirty minutes in normal subjects. Experiments are yet to be done in subjects with neurological conditions.

Over all the conference, while exhausting due to the sheer pace and volume of activity, was extremely encouraging. While it would have been good to hear about more clinical outcomes, the evident progress in technology and understanding of its effect on the human body will undoubtedly lead to useful clinical applications.

For more information about IFESS check their Web page which is linked from our page: www.mpbe-sdh.demon.co.uk

Paul Taylor


The efficacy of Functional Electrical Stimulation in improving walking ability for people with Multiple Sclerosis

Swain,I.D., Burridge, J.H., Johnson,C.A.., Mann, G.E., Taylor P.N., Wright, P.A.,

5th IFESS meeting, Aalborg University June 2000

Introduction

Multiple Sclerosis, MS, is a chronic disease of unknown cause which affects the central nervous system and is characterised by demyelination of nerve fibres in the brain and spinal cord. It effects over 85,000 people in the UK and between 250-350,000 people in the United States. It is five times more common in temperate climates than in tropical regions (1). It is an unpredictable disease making prognosis difficult and symptoms can range from relatively benign to devastating, as communication between the brain and the peripheral nervous system is disrupted. As MS affects the central nervous system it can cause muscular weakness, reduced sensation, spasticity, fatigue and ataxia in addition to pain, balance problems, bladder, bowel and sexual dysfunction, speech and visual disturbances and altered mental state.

The disease progression is variable and usually follows one of several patterns. Most common is relapsing -remitting (RR) which is a series of attacks followed by complete or partial remission only to reoccur after a period of stability. Primary -progressive (PP) is characterised by a steady decline with no distinct remissions. Secondary-progressive (SP) begins with a relapsing-remitting course followed by a later primary progressive course. Rarely patients may have a progressive-relapsing (PR) course in which the disease takes a progressive path followed by acute episodes. In addition 20% of the MS population have a benign form of the disease which shows little or no progression after the initial attack. As a result of this variability of symptoms and progression any clinical trials in MS are notoriously difficult.

Most people with MS experience muscle weakness in their extremities and difficulty with coordination at some time during the course of their disease which may be severe enough to affect walking (1). Foot drop is one of these effects and may occur either unilaterally or bilaterally. It may be characterised by an isolated weakness of the foot dorsiflexors but it is more usual for other movements to be affected as well, commonly reduced knee flexion. Spasticity may also be a factor which contributes to difficulty in mobility.

The ODFS III is a single channel, foot switch triggered stimulator designed to elicit dorsiflexion of the foot by stimulation of the common peroneal nerve, (max. amplitude 100mA, 350m s pulse, 40 pps). Skin-surface electrodes are placed, typically, over the common peroneal nerve as it passes over the head of the fibula bone and the motor point of tibialis anterior. The rise and fall of the stimulation envelope and extension after heel strike can be adjusted to prevent a stretch reflex in the calf muscles and to prevent "foot flap" due to the premature ending of dorsiflexion.

The ODFS was the subject of a randomised controlled trial in which 32 stroke patients who had had a stroke for in excess of 6 months were allocated to a treatment group who used the device and received 12 sessions of physiotherapy and a control group who only received physiotherapy (2,3,4). After three months of use the treatment group showed a statistically significant increase in walking speed of 16% and reduction in the Physiological Cost Index (PCI) of 29% when the stimulator was used while no changes were seen in the control group (3). No significant 'carry-over' effect was seen although a trend was present. Users of the ODFS showed a continuing reduction in quadriceps spasticity which was only seen in the control group while physiotherapy continued (4). The treatment group also showed a reduction in depression score on the Hospital Anxiety and Depression index suggesting an improvement in quality of life. The trial results were presented to the South and West Regional Health Authority Development and Evaluation Committee who subsequently recommended the ODFS for use in the National Health Service.

Methods

After the ODFS is fitted the patient is seen the following day, after six weeks, after a further three months and then every six months as long as they continue to use it. Walking speed and PCI, which is an indication of the amount of effort expended, are measured at every appointment. The patients are asked to "walk briskly" over a 10m course with 1m at either end for acceleration and deceleration. Patients normally walk this course three times with stimulation and three times without, the order of stimulation / nonstimulation being varied to compensate for any fatigue. The mean speed and PCI for stimulated and non-stimulated walking is calculated. PCI being the change in heart rate (bt/min) / walking speed (m/min). The heart rate was measured using a Polar Heart Rate Monitor. The data in this study were obtained retrospectively from the records of these routine measurements kept in the patients notes.

In addition a questionnaire was sent to all current and former users of the ODFS, 168 and 123 respectively. A stamped addressed envelope was included to facilitate their return. The questionnaire consisted of 16 questions which sought to determine what advantages the ODFS gave; when, how and where it was used, if it made any difference to the patients use of other aids, whether the instructions, both verbal and written were satisfactory and whether the repair/advice service we were providing was responsive. Those who had stopped using the stimulator were asked why they had stopped.

Results

We have assessed 139 people with MS who have been found to be suitable for treatment, 24 of whom were bilateral. Their average age is 53.4 years SD 11.1. Of these 139 there is speed/PCI data on 112, as some patients have been assessed but have not started treatment. The reason that complete data is not available on all subjects is primarily due to the fact that some patients fatigue so rapidly that they are unable to complete all the tests. The figures presented below are only on those patient on whom complete data is available.

The longest any MS patient has been using the ODFS is over six years since commencing treatment on 29/3/94. Nine patients have used it, or a bilateral system for over three years.

Of the 139 patients only 16 have stopped treatment giving a compliance of 88%.

Initial orthotic effect (IOE) is defined as the mean % change in speed/PCI with and without stimulation at the start of treatment.

Final orthotic effect (FOE) is defined as the mean % change in speed/PCI with and without stimulation after a period of treatment. e.g. 4 1/2 months or 3 years

Total orthotic effect (TOE) is defined as the mean % change in speed/PCI with stimulation after a period of treatment compared to that without stimulation at the start of treatment.

‘Carry over’ effect (COE) is defined as the mean % change in speed/PCI without stimulation after a period of treatment compared to that without stimulation at the start of treatment.

Positive values of percentage change in walking speed indicate faster walking. Positive values of percentage change in PCI indicate an increase in effort, negative values a reduction in effort

Table 1 Changes in Walking Speed and Energy Expenditure after four and a half months usage, ODFS (52 patients)

N.B. Patients who can not walk 10m without stimulation are not included.

Pre use

 

 

 

 

Mean PCI No stim.

 

Mean PCI Stim

 

Mean Speed No Stim

 

Mean Speed Stim

 

1.09

 

1.03

 

0.49ms-1

 

0.53ms-1

 

After4.5 months use

 

 

 

 

1.03

 

0.84

 

0.51ms-

 

0.59ms-1

 

 

Speed

 

PCI

 

IOE

 

10%***

 

-11%***

 

FOE

 

5%***

 

-6%

 

TOE

 

16%

 

-20%

 

COE

 

-1%

 

-4%

* p<0.05, **p<0.01, **p<0.001 paired t-test

Table 2 Changes in Walking Speed and Energy Expenditure after three years usage (6 patients, includes patients using both the ODFS and two channel stimulator).

N.B. five of the subjects walked faster with the stimulator at the start of treatment but one subject walked considerably slower. Their walking improved after using the stimulator for some time.

Pre use

 

 

 

 

Mean PCI No stim.

 

Mean PCI Stim

 

Mean Speed No Stim

 

Mean Speed Stim

 

1.03

 

1.05

 

0.44ms-1

 

0.47ms-1

 

After4.5 months use

 

 

 

 

1.25

 

0.85

 

0.35ms-1

 

0.47ms-1

 

 

Speed

 

PCI

 

IOE

 

6%

 

- 1%

 

FOE

 

36%

 

-29%

 

TOE

 

8%

 

-17%

 

COE

 

-10%

 

21%

Table 3 Changes in walking speed and PCI due to two channel stimulator for bilateral footdrop (10 patients)

Pre use

 

 

 

 

Mean PCI No stim.

 

Mean PCI Stim

 

Mean Speed No Stim

 

Mean Speed Stim

 

1.57

 

1.13

 

0.27ms-1

 

0.32ms-1

 

After 4.5 months use

 

 

 

 

1.65

 

1.25

 

0.30ms-1

 

0.35ms-1

 

 

Speed

 

PCI

 

IOE

 

37%**

 

-25%**

 

FOE

 

40%*

 

-18%*

 

TOE

 

56%

 

-12%

 

COE

 

18%

 

11%

Questionnaire

Of the current ODFS users107 replies were received from the 160 questionnaires that were sent out of which 15 had MS. Of the former users 53 replies were received from the 123 questionnaires that were sent out, only 3 of who had MS, two stopped using the stimulator because of a deterioration in their general condition and the other had an increase in their spasticity. The replies received the current users were different from the rest of the respondents, the majority of whom had a dropped foot as a result of a CVA. Amongst those with MS by far the most common reason for using the ODFS was the reduction of effort, 100% (5)

Discussion

The results on the main group of patients, i.e. those who have used a stimulator for four and a half months show that electrical stimulation significantly improves both walking speed and walking efficiency. Unlike the initial work (6) it was also encouraging that some patients exhibit a ‘carry over’ effect over the four and a half month treatment period. Walking speed of >10% was seen to increase in 16 out of the 52 patients and PCI reduce by > 10% in 21 patients.

In the 3 year follow up group the numbers were small but showed that there was a marked final orthotic effect and even after three years the majority of patients were walking faster and more efficiently with the stimulator than they were without the stimulator at the time they were referred for treatment. As the numbers are so small, statistical evaluation was not undertaken. Three patients were walking faster without stimulation after three years than they were initially and two were walking more efficiently.

The results obtained with the two channel bilateral foot drop stimulator (7) showed an improvement in both walking speed and PCI when using the stimulator which was statistically significant compared to the results obtained without stimulation. The readings taken after four and a half months showed no statistically significant difference compared to the initial readings, although the sample size was small.

The questionnaire showed that MS patients gave slightly different reasons for using the stimulator compared to the majority of patients who had had a CVA, in that reduction in effort was the main reason they used it. This can be seen in the final orthotic effect after three years use when it can be seen that it did make a considerable difference to their walking. It is also noticeable that the bilateral stimulator also makes a considerable difference. Therefore it might be inferred that as people with MS become more disabled by the progressive nature of the disease that the stimulator becomes more important in preserving their mobility and hence independence. It is probably not surprising therefore that we have had such a small drop out rate from MS patients with only 16 out of 139 stopping treatment.

It was disappointing that we were not able to report on more subjects when 139 had been assessed, although we will be able to over the next few years as the recent influx of patients progress through the system.

It is always difficult with any severely disabled group to record objective data taken at set times as the variable nature if the disease often means that clinic appointment are difficult for the patients to attend especially as we see patients from all over the United Kingdom.

References

1) National Institute of Neurological Disorders and Stroke - Multiple Sclerosis www.ninds.nih.gov

1 Liberson W, Holmquest H, Scott M. Functional electrotherapy: Stimulation of the common peroneal nerve synchronised with the swing phase of gait of hemiplegic subjects. Archives of Physical Medicine and Rehabilitation. 1961. 42. 202-205.

2 Burridge J, Taylor P, Hagan S, Swain I. Experience of clinical use of the Odstock Dropped Foot Stimulator. Artificial Organs. 1997. 21(3). 254-260.

3) Burridge J, Taylor P, Hagan S, Wood D, Swain I. The effects of common peroneal nerve stimulation on the effort and speed of walking: A randomised controlled clinical trial with chronic hemiplegic patients. Clinical Rehabilitation. 1997. 11. 201-210.

4) Burridge J, Taylor P, Hagan SA, Wood DE, Swain ID. The effect on the spasticity of the quadriceps muscles of stimulation of the Common Peroneal nerve of chronic hemiplegic subjects during walking. Physiotherapy vol. 83, no 2 1997

5) Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton, C, Swain ID. Patient perceptions of the Odstock Drop Foot Stimulator. Clinical Rehabilitation,13: 333-340, 1999.

6) Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton, C, Swain ID. Clinical use of the Odstock Drop Foot Stimulator - its effect on the speed and effort of walking. Archives of Physical Medicine and Rehabilitation, 80: 1577-1583, 1999.

7)Taylor PN, Wright PA, Burridge JH, Mann GE, Swain ID. Correction of bilateral dropped foot using the Odstock 2 Channel Stimulator (O2CHS). Ibid., pp. 257-260, August 1999

 


Initial experience in the use of Functional Electrical Stimulation in a variety of neurological conditions resulting in facial palsy

Mann, G.E., Swain, I.D. , Cole, R.

5th IFESS meeting, Aalborg University June 2000

Introduction

There are a number of different causes for facial paralysis the mostly common of which is Bell's Palsy, however it can also be caused by otitis media, trauma, CVA, surgery, tumour or of congenital origin (1). Bell's Palsy alone affects between 0.16 and 0.25 per 1000 in Britain each year. The majority of these, 80%, recover spontaneously over a period of 6-12 weeks, nevertheless some remain affected. Whatever the cause there are a significant number of patients who manifest with the devastating stigmata of the condition. (2) There are a variety of treatments for this condition, which include; surgical decompression, steroids etc. Once conditions have become chronic a variety of plastic surgery procedures are available to improve symmetry. Surgery can consist of static or dynamic procedures. Static procedures, which are designed to improve the symmetry of the face at rest include canthoplasties to restore position of the lower eyelid and static facial slings to support the corner of the mouth. Dynamic procedures offer the chance for movement of the paralysed face and these can be divided into muscle transfers using the masseter and temporalis muscle to provide movement. More complicated procedures comprise of free microvascular transfers of muscles from elsewhere in the body into the face using microsurgical anastomosis of its blood vessels, motorised by a facial nerve graft from the non-paralysed side.

The use of electrical stimulation to treat facial paralysis has not been widely used, however a few papers using a variety of stimulation regimes have been published over the past few years (3,4,5). The greatest interest occurred in the mid 1980's with the advent of eutrophic stimulation which used a pattern of stimulation based on that of EMG activity of the facial muscles. The stimulation intensity is not sufficient to cause muscular contraction, being up to 18v, 80 mS rectangular monophasic pulses. In their trial (2), which was only in chronic cases, they found a significant improvement in the treatment group compared to the conventional therapy group. Despite these findings then authors know of no other groups who are using eutrophic stimulation today. No definitive explanation has been given as to how eutrophic stimulation works.

One of the problems in evaluating any treatment in Bells Palsy in particular, is that the majority of people do get symptomatic improvement with time (6). Although this report was written in 1984 there is still considerable scepticism within the medical profession as to whether electrical stimulation has a role to play in t he treatment of facial paralysis.

Methods

For this reason the only people we have are those with chronic conditions, referred to the Plastic Surgery Department in Salisbury for whom other treatments have failed. Sometimes these patients have already had surgery, whereas for other electrical stimulation is undertaken initially. All of the patients referred have had flaccid paralysis.

Stimulation is provided by a two channel microprocessor controlled stimulator producing 300mS balanced monophasic pulses at 10-40 pps, with an output of up to 120mA. Pals Plus 2 electrodes are used and are individually cut to suit each individual. The most commonly stimulated muscles are zygomaticus major, levator labii, levator labii superioris alequae nasi, levator anguli oris and frontalis.

Most people find the sensation of stimulating facial muscles to be painful and therefore care needs to be taken when adjusting the stimulation intensity. Prior to stimulation it is necessary to thoroughly clean the skin to remove any traces of cosmetics. It is often best to initially stimulate the unaffected side of the face as it enables the motor points to be determined and enables the clinician to determine the likely level of stimulation necessary to cause a contraction. Electrodes need to be small and are best placed close together so that the current path is superficial. If the current path is deeper nerves of the teeth may be activated which causes pain.

As the stimulation intensity is increased the patient’s face is carefully observed and the threshold levels needed to initial movement noted. Once it has been determined which muscles can be stimulated a training regime is determined for each patient. The patient is then shown how to use the stimulator and apply the electrodes and seen at regular intervals so that their progress can be monitored. Digital photographs are taken both with and without stimulation at each assessment as well as with the patient trying to actively move their face. To facilitate record keeping a standard set of photographs are always taken.

Results

Patient 1 Age 60 facial paralysis due to polio at age 9 years. Period of stimulation 18 months. Regained some voluntary control without stimulation but can not sustain facial expressions.

Patient 2 Age 56, facial paralysis following removal of brain tumour in 1995. Period of stimulation one year. Some movement now possible.

Patient 3 Age 23, congenital facial palsy. Period of stimulation 20 months. Good response with stimulation, some improvement in voluntary movement.

Patient 4 Age 7, congential facial palsy. Just commenced treatment. Some movement with stimulation.

Patient 5 Age 44, Facial paralysis following RTA two years ago. Using stimulation for one year. Able to achieve movement with FES. Some improvement in voluntary function.

Patient 6 Age 41 years, facial paralysis due to acoustic neuroma three years ago, also has severe facial pain. Using stimulation for three months. Some increased facial movement with stimulation. Pain reduced when stimulation on.

Patient 7 Age 57, facial paralysis following surgery as a child. Using stimulation for 18 months. Some voluntary control, now symmetrical around eye and cheek, feels much more confident in social situations, skin condition improved.

Patient 8 Age 21, congenital facial palsy. Using stimulation for 6 months. Some improvement in voluntary control.

Patient 9 Age 65, Bells Palsy two years ago. Using stimulation for 14 months. Some improved symmetry around the mouth. Improved response with stimulation but little improvement in voluntary control.

Patient 10 Age 54, CVA twelve months ago. Using stimulation for three months. Improved ability to open her eye. Improved control of mouth and nasal muscles.

Discussion

Despite this limited success we realise that the treatment regime is not optimised. And more information is needed on the possible mechanism by which improvement occurs. It is apparent that all of these cases must be incomplete by the very fact that we were able to elicit a response using electrical stimulation with parameters such as those used here. To do this detailed neurophysiological assessment should be undertaken prior to commencing treatment and at regular intervals for as long as treatment is continued.

We realise that our experience in these techniques is limited, however we have been surprised by the results we have observed in some patients, especially subject 1 who had had a facial paralysis for 50 years after having polio as a child and subject 7 who had had facila paralysis for 35 years. Both of these subjects were pleased with the difference stimulation had made and both stated that they felt more confident in social situations.

It was also apparent that none of the patients who were able to perform voluntary movement were able to make sustained contractions. It was felt that this might be expected due to the length of time that the patients had suffered from facial paralysis meant that any muscles that did remain would be very easily fatigued. As the daily time spent stimulating the muscles was comparatively short it would not be expected that their would be any change in muscle fibre type and hence improvement in fatiguability. (7) To overcome this problem stimulation would need to be applied for considerably longer periods each day, possibly overnight. It is not felt to be practical to undertake this using surface electrodes and that percutaneous electrodes would appear to offer the beast chance of success.

In conclusion we were surprised that some of these patients with symptoms lasting many years responded so well to electrical stimulation. We realise the limitations of the work to date but feel that this is an area worthy of further study, incorporating more detailed neurophysiologcal assessment and monitoring. It is hoped that by combining electrical stimulation with new techniques in plastic surgery that the physical and psychological symptoms that this group of patients suffer can be considerably reduced.

References

1. Rothstein,J and Berlinger, NT, Electronic reanimation of facial paralysis - a feasibility study. Otolaryngology - Head and Neck Surgery Vol 94 No 1 pp82-85 1986

2. Farragher, D., Kidd GL., Tallis R., Eutrophic electrical stimulation for Bells Palsy Clin Rehab 1987;1;265-271

3. Gittins J., Martin K., Sheldrick J., Reddy A., Thean L., Electrical stimulation as a therapeutic option to improve eyelid function in chronic facial nerve disorders Invest Ophthalmol Vis Sci 1999 Mar;40(3) :547-54

4.Targan RS., Alon G., Kay SL., Effect of log term electrical stimulation on motor recovery and improvement of clinical residuals in patients with unresolved facial nerve palsy. Otolaryngol Head Neck Surg 2000 Feb;122(2):246:52

5.Williams HB., A clinical pilot study to assess functional return following muscle stimulation after nerve injury and repair in the upper extremity using a completely implantable electrical system Microsurgery 1996;17(11):597-605

6. Electrotherapy for treatment of facial nerve paralysis Health Technology Assessment Reports No 3 1984. National Centre for Health Services Research. US Dept of Health.

7. Swain ID 'Conditioning of Skeletal Muscle by Long Term Functional Stimulation - Implication for the Development of Practical Systems in Spinal Cord Dysfunction Vol. 3 Ed. Illis L., Oxford Medical Publication -1992.


Electrical stimulation of abdominal muscles for control of blood pressure and assisted cough in a C4 level tetraplegic.

PN Taylor, A Tromans, ID Swain.

5th IFESS meeting, Aalborg University June 2000

Introduction

Autonomic dysreflexia is a common complication of spinal cord injury above the spinal level of T61. It manifests as a sudden rise in blood pressure in response to a noxious stimulus below the level of the lesion and, if the stimulus is not removed can lead to headache, cutis, anserina (goose flesh), paresthesias, shivering, flushing and other symptoms. The rise in blood pressure is a consequence of reflex arterial spasm in response to the stimulation of the sympathetic nervous system. In the intact nervous system baroreceptors in the cerebral vessels, carotid sinuses and aorta detect the hypertension and stimulate a parasympathetic response resulting in vasodilatation, and a fall in heart rate. However, in this group, the signals are blocked by the lesion, the resulting vasodilatation only occurring above the lesion. This is insufficient to return the blood pressure to normal levels. In a similar manner, lowering of blood pressure due to change of posture from lying to a more upright posture can be poorly controlled resulting in postural or orthostatic hypotension.

Autonomic dysreflexia in response to electrical stimulation has been reported by several authors. Ashley2 et al. reported rises in blood pressure in response to resistance training using electrical stimulation of the quadriceps muscles. The rise would occur immediately on starting the electrical stimulation but blood pressure returned to normal levels very quickly after stimulation had stopped. More recently, Sampson3 et al. Reported an investigation into the effect of electrical stimulation on blood pressure in C5 – T4 SCI subjects with induced orthostatic hypotension. In this study, repeatable falls in blood pressure was induced using a tilt table. At two separate sessions, the quadriceps and pretibial muscles or the patellae and malleoli were stimulated using a 50 Hz, 250 m s wave form with currents up to 160 mA. Consistent rises in blood pressure were recorded, overcoming the fall due to induced orthostatic hypotension, whichever stimulation site was used, suggesting that the increase in the muscle pump action on venous return was not a significant factor in the effect. The rise in blood pressure increased with increasing stimulation amplitude but plateaued after 96 mA.

This paper describes a single case study of the use of FES to increase the blood pressure of a C4 ventilator dependent tetraplegic (male, 40 years of age) who was subject to chronic postural hypotension. This was fairly well controlled by the drug Midon (midodrine hydrochloride) but low blood pressure remained a problem, particularly after meal times. Additional the subject controlled his own blood pressure by adjusting his posture by tilting the back and leg rests of his electric wheel chair, controlled by a chin joystick. The subject was unable to produce a voluntary cough and was dependent on manual assistance and suction to maintain his airways.

It was found that a rise in blood pressure could be induced by stimulation of the common peroneal nerve, quadriceps muscles or the abdominal muscles. By closing his epiglottis, the subject was able to stack up to three breaths. When stimulation of the abdominal muscles was timed to occur just before the end of the third inhalation period, a cough of some force was produced 4.

Method

As the subject was very aware of the status of his blood pressure, it was decided to use a self-administrated system. Two pairs of electrodes were used to stimulate the upper and lower abdomen. An Odstock 2 Channel stimulator (O2CHS)5 was used. This device is a foot switch controlled stimulator intended for gait assistance in SCI MS and stroke. In this application its foot switch input was controlled by a spare channel of the wheelchair joystick controller. When the joystick was pushed forward, the stimulator gave a 1 second burst of 300m s 40Hz stimulation at amplitudes adjustable between 0 and 80 mA. With a little practice, the subject was able to synchronise the stimulation with epiglottis control and the ventilator’s cycle.

The system was used in this form for some months but it soon became apparent that blood pressure was best controlled by fairly frequent but low level bursts of stimulation, lower than that required to produce a cough. The cough function was required less frequently and so the user required assistance to increase the levels of the device when he wanted to cough. It was therefore decided to design a system which allowed user selection of two pre-set levels of stimulation by use of the chin joystick. The new system delivers a low level stimuli if the joystick is flicked for a short time but a larger output is selected if the joystick is pushed forward for three seconds and then releases. An audio warning is given when the cough setting is selected.

Assessments

Blood pressure was measured using a calibrated AND digital blood pressure monitor (UA-767). It was measured prior to electrical stimulation, immediately after stimulation and then at two minute intervals until it returned to its previous level. Peak expiratory flow was measured using a spirometer.

Results

Following eating a blood pressure of 60 / 45 mmHg was recorded. After five 1 second bursts of stimulation at an amplitude of approximately 40mA in quick repetition, this was increased to 133 / 92 mmHg. After 2 minutes blood pressure had fallen to 124 / 86 mmHg and to 93 / 66 after a further 4 minutes. The electrical stimulation was then repeated, returning the blood pressure to the previous higher level.

Measurement of peak expiratory flow showed an increase from 275 l/min for an unassisted cough to 425 l/min when using the device. This in the normal range.

The system has been in daily use for 1 year. Typically it is used for regulation of blood pressure after eating. Bursts of stimulation are self-administered every 3-5min immediately after a meal and the period between bursts gradually increased over 90 minuets. At this point the device would typically be used hourly.

The user is now independent in coughing function and no longer requires suction or manual assistance.

Discussion

This paper describes a device designed to respond to the specific problems of one individual and it is not clear if it would have application in a wider group. Further work is required to obtain a better understanding of the mechanism of its action. That said, the device has been well accepted by its user and it would appear that by better maintenance of homeostasis, it has contributed to an improved quality of life.

References

[1] Karlsson AK. (1999) Autonomic dysreflexia, Scientific review. Spinal Cord: 37 383-391

[2] Asley EA, Laskin JJ, Olenik LM, Burnham R, Steadward RD, Cumming DC, Wheeler MD (1993) Evidence of autonomic dysreflexia during functional electrical stimulation in individuals with spinal cord injuries. Paraplegia 31 593-605

[3] Sampson EE, Roberts MD, Burnham RS, Andrews BJ. (2000) Functional Electrical Stimulation Effect on Orthostatic Hypotension After Spinal Cord Injury. Arch Phys Med Rehabil Vol 81 139-143

[4] Linder SH (1993) Functional Electrical Stimulation to enhance cough in spinal cord injury. Chest. Vol103 166-169

[5] Taylor PN, Wright PA, Burridge JH, Mann GE, Swain ID. (1999) Correction of Dropped Foot using the Odstock 2 Channel Stimulator (O2CHS). 4th annual IFESS

conference pp.257-260 ISBN4-9980783-0-5


Equipment News

A new version of the ODFS has been made produced in which the old plastic amplitude control has been replaced with a metal version. This will be more robust than the previous version.

We now have all stimulator manuals available in French. ODFS user manuals are also available in Dutch, Danish, Spanish and Italian and soon also in German. If you require other translations, please let us know and we will see if it is possible.

As always, we welcome any feed back on the design and function of the Salisbury FES equipment. Please send any comments you have to Paul Taylor or Stacey Finn at Salisbury.


Forthcoming Courses, lectures and Meetings

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. The second course, intended for clinicians that have some experience of the ODFS, introduces the O2CHS.


Introductory Courses

School of Health Professionals and Rehabilitation Sciences, University of Southampton, Hightailed, Southampton. SO17 1BJ. 8yh and 9th of September 2000 Contact Jane Burridge 0238 0595 908

If you would like a course to be held at your own hospital, please contact Paul Taylor.


O.D.F.S and 2-Channel Nominated for Nye Bevan Award

On 5th July 2000, the 52nd anniversary of the founding of the NHS, Professor Ian Swain (Head of Department), Deon Buhrs (research physiotherapist), Fiona Moody (work placement student) and myself (technician) attended The Learning Exchange and the Nye Bevan awards at the London Arena. The Odstock Dropped Foot Stimulator (O.D.F.S) and the 2-channel walking stimulator (O2CHS) were nominated for the new category ‘Best Innovation in Health’ award. This award was for groundbreaking scientific or technological development, which would have an impact on the quality of care for patients. We were one of the 6 short listed for the award! Voting was carried out by visitors to the Future Health Stand at the Tomorrow’s World Live event.

The award ceremony was like the Oscar’s and we found ourselves sitting on the front table talking to the presenters of GMTV, the host’s for the event! With all the TV cameras whizzing around it was quite a shock! "And the winner of the Best Innovation in Health award goes to Professor............................David James Kerr of University Hospital Birmingham NHS trust for work involving genetically modifying the common cold virus to carry a suicide gene, which will selectively infect and kill cancer cells". Oh well, maybe next year! However, it wasn’t a wasted journey as just by being nominated helped bring more awareness of the ODFS and the FES work carried out by ourselves at Salisbury and you in your clinics (a free trip to the Millennium Dome was included for all nominees, but that’s not why we went - honest).

The Learning Exchange

In addition to the awards ceremony itself, the National Learning Exchange also took place. This was in the format of presentations, posters and stands. The aim was to spread information, ideas and techniques for modernising the NHS, with National Improvement Teams and the Learning Network helping to build the capability for such modernisation.

A couple of interesting websites came up whilst wandering around: For those carrying out research, or thinking of doing so should definitely visit http://www.doh.gov.uk/research/nrr.htm (National Research Register). Another interesting site was the popular ‘NHS Direct’ website that could be useful for general information and has many links to other medical related sites: http://www.nhsdirect.nhs.uk/

Stacey Finn


IMPULSE

(Improved Mobility through imPlanted fUnctional eLectrical Stimulation of nErves)

The purpose of this project is to investigate the safety and efficacy of the Finetech Implanted Dropped Foot Stimulator. This device is a 2 channel implanted neuromuscular stimulator intended for the correction of dropped foot following stroke. The device has been developed by the University of Twente and Roessingh Research and Development in Holland in collaboration with the UK based company, Finetech-Medical Ltd who have organised this trial with funding from Medlink.

While the ODFS has proved to be a successful orthotic and training aid for improving gait, many users have difficulty reliably finding the positions for the skin surface electrodes. Additionally, some users experience problems with skin reactions to the electrodes. By implanting the stimulator, it is envisaged that these problems will be avoided as well as providing a device that is more convenient to use.

The nerve that controls the lifting of the foot in walking is called the common peroneal nerve. At a point, just below the knee, this nerve splits into two branches, the deep branch and the superficial branch. The deep branch goes to the muscles that dorsiflex and invert the foot while the superficial branch supplies the muscles that cause eversion. In normal walking, a combination of these movements is required. Therefore an electrode is surgically inserted in both nerves enabling the movements to be controlled separately. The nerves are stimulated at a frequency of 30Hz, a pulse width of 300¼s and at current amplitudes of up to 1mA. This causes nerve impulses to travel down the nerve to the muscle in the same way as naturally occurring nerve impulses. Power to run the stimulator is passed through the skin using radio waves from a small control box strapped to the outside of the leg. To stimulate the muscles at the correct time a foot switch is use to detect when the foot is lifted from the ground. Stimulation begins when the foot is lifted and ends when the heel is returned to the ground. Sensation from the electrical stimulation should be very slight and it is expected that users will quickly become accustomed to it. Use of the system will be automatic; the user only has to set the stimulation intensity using two control knobs. Once healing has occurred the operation site scars should be negligible. It may be possible to palpate the implant under the skin but it is not expected to be noticeable to the eye.

Initially the devices will be implanted under general anaesthetic and will require at least one overnight stay in hospital. However, once experience has been gained it is hoped that the operation can be carried out in day surgery under an epidural. Initial assessments of the system will concentrate on verifying the safety and function of the device. If the device proves to be successful, a multi-centre, randomised controlled trial will follow.

The first of two devices has been implanted in The Netherlands in July 2000 and will be followed by 5 in Salisbury in the autumn. Initial trials will be with stroke subjects but it is expected the device will also be applicable to people with other neurological conditions.

As part of the project we have been asked to find out the opinions of clinicians regarding the clinical need for and acceptability of an implanted dropped foot stimulator. At the end of the newsletter there is a questionnaire. We would be most grateful if you could complete and return the questionnaire in the stamped addressed envelope provided. Thanks.

 

Paul Taylor


Meeting Review – Introduction to the Neuro Control StIM System

The meeting took the form of a four way teleconference between Cleveland Ohio, Frankfurt, Paris and London. In the chair was Geoff Thrope of the Neuro Control Corporation in Cleveland who introduced the device. The StIM system is an 8 channel percutaneous muscle stimulator housed in a pager style case approximately 5 x 7 x 2 cm in size. Stimulation is delivered via barbed electrodes on the ends of leads that are passed through the skin using a hypodermic needle. The exposed leads are then terminated together at a single connector, which is linked to the StIM unit by a single cable. The connector and electrode entry site is covered by a dressing. The user need only press a button to start the stimulator. Percutaneous electrodes have the advantage that they allow very precise stimulation of specific muscles with reduced current levels and sensation compared with skin surface stimulation. Their obvious drawback is that there is an increased risk of infection. However, NCC claim that the risk is negligible if the application time is limited to 6 weeks. There has been of the order of 25 years research experience with this type of electrode.

Dr David Yu then described initial clinical experience of the StIM system. Its first application has been in the treatment of subluxed shoulder. In a recent survey it was claimed that up to 84% of hemiplegics had experienced shoulder pain due to subluxation. Surface stimulation had been shown to be effective at reducing the pain but it was thought to be difficult to administer at home. In a pilot study, 11 subjects who had had a stroke of average duration 13 months received electrical stimulation exercises for 6 hours a day for 6 weeks. Four electrodes were stimulated in two pairs. The first pair was posterior deltoid and supraspinatus, the second pair middle deltoid with the upper fibres of trapezius. The pairs are alternated, overlapping to maintain the humerus in the capsule.

Subluxation was measured using x-ray and before the trial was an average of 10mm. After 6 weeks this had reduced to 6mm and after three months follow up in which time the StIM system was not used, had reduced further to 4mm. Pain, measured using visual analogue scales was also significantly reduced at 6 weeks but slightly increased at three months compared to 6 weeks. Improvements were also shown using the Fugal Myers score and the FIM (Functional Independence Measure). No discomfort was experienced from the electrical stimulation.

Encouraged by these results the company is presently undertaking a Randomised Controlled Trial to enable it to obtain FDA (Food and Drug Administration) approval for the USA market. As the safety of the device has been shown, it has been awarded the CE mark for use in Europe and so is available for clinical use. It is hoped that the device will find many other applications where an accurate and repeatable stimulation is required.

 

If you would like more information about the StIM system, contact Frank Salussolia of Mercury Medical who is Neuro Controls Representative in the UK. Tel. 0831 105501

 

Paul Taylor


Book Review

Neuro Muscular Electrical Stimulation. A Practical Guide. 4th Edition

Lucinda L. Baker, Cynthia Wederich, Donald R McNeal, Craig Newsam, Robert L. Waters

ISBN 3-79985-06221-1

A new edition of what is probably the best guide to the therapeutic use of electrical stimulation exercises has just be released by the Rancho Los Amigos Research & Education Institute. The new edition has improved sections on indications, contraindications and suggested treatment programs. Extensive evidence is given for the efficacy of each treatment by reviewing the published literature. New to this edition are case studies to illustrate the suggested therapies and also exercises for students to follow. As before, there is an excellent introduction to the theory and physiology behind electrical stimulation of muscle. Also given is a guide to electrode placements in the upper and lower limbs. This book is a useful reference for anyone involved in the practical application of electrical stimulation based therapies.

The "Rancho Book" as it is almost always referred, is available from Nidd Valley Medical, tel. 01423 799 115

Paul Taylor


Current price list

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 items.

Sounder £10

Wow pedal (for O4CHS) £75

Electrode leads (1.0 or 1.5m) £8.90

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

Double Foot Switch Leads £22.40

Foot switch £22.40

Double foot switch £34.70

The above prices do not include VAT. VAT is not chargeable to purchases in the NHS or if a VAT exemption certificate is supplied with order.

Other lead lengths are available on request

Electrodes

Number Electrode 1-9 10-29 30+

879100 Pals 1 ¼" (32mm) £8.77 £7.89 £7.46

881150 Pals 1 ½ " (38mm) £6.70 £6.70 £6.70

879200 Pals 2" (50mm) £9.68 £8.70 £8.23

879300 Pals 3" (70mm) £13.61 £12.26 £11.57

891200 Pals 1 ¼ (30x50mm) £9.23 £8.30 £7.85

901220 Blue Pals 2"x2" (50x50mm) £9.68 £8.72 £8.23

Electrode prices include VAT. VAT can not be claimed back on these items.


If you would like to contribute to the next issue of the FES Newsletter or advertise a course or meeting please send copy to us by December 15th 2000 for the winter edition.

Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ.

Tel. 01722 429 065 Fax. 01722 425 263 E-mail enquiries@mpbe-sdh.demon.co.uk Web page mpbe-sdh.demon.co.uk


IMPULSE QUESTIONNAIRE

Dear Clinician,

We are writing to you to ask your opinion regarding the future direction of our R&D and clinical service. As you may know, we currently provide a clinical service to improve the mobility of people who have neurological problems such as stroke, multiple sclerosis and spinal cord injury using the Odstock Dropped Foot Stimulator (ODFS). This system applies stimulation to the common peroneal nerve using surface electrodes and leads.

While the ODFS has proved to be an effective orthosis and gait re-education aid, we wish to investigate the possibility of improving our service by using an implanted stimulator. At this stage, the benefits and costs associated with the implant are not yet clearly defined. We are therefore asking you to comment on more general issues – how you view the problems with the surface stimulator and some idea on how much additional cost (money and additional treatment for the patient) would be justified in a new system that could provide a solution to these problems.

The questionnaire should not take more than 10 minutes to fill in. We thank you in advance for your co-operation.

Background information

Patient selection criteria for dropped foot stimulation are currently:

Following a number of years experience, it has been found that some problems can arise from use of skin surface stimulation. These are:

IMPULSE

The purpose of the ‘Impulse’ (Improved Mobility through imPlanted fUnctional eLectrical Stimulation of nErves) project is to investigate the safety and efficacy of an implanted stimulator system for dropped foot. The device has been developed by the University of Twente and Roessingh Research & Development in Holland in collaboration with the UK based company, Finetech- Medical Ltd. By implanting the electrodes and providing more specific control over the muscles activated, it is envisaged that most of the problems described above will be overcome. The system will function as follows: Power and control signals will be passed to the implanted electrodes by radio waves from a small control box that will be strapped to the lower leg. Using two control knobs the user will adjust the strength of the stimulation applied to the two nerves. As with the ODFS, the timing of the stimulation will be controlled by a footswitch. It is expected that implantation will take about 1 hour and will require at least one overnight stay in hospital. Initially, it is planned to use a general anaesthetic, but it may be possible to implant the device under an epidural. As with any operation where an anaesthetic is used, there is some risk involved.

Financial Implications of treatment:

Odstock Dropped foot Stimulator

Treatment costs in the first year are approximately £1,000 (including equipment (£272.25), consumables and clinical time) and £200 in subsequent years for as long as the stimulator is used.

IMPULSE

Treatment costs in the first year are estimated to be approximately £3-4000 (including equipment, theatre time, consumables and clinical time) and £160 in subsequent years for as long as the stimulator is used. It is possible that the implanted device will require less follow up than the ODFS.

This questionnaire is being administered as part of the IMPULSE project, which is financed by joint funding from a DTI MEDLINK grant and Finetech Medical Ltd.

The Questions:

1. In your clinical experience of the ODFS, how seriously (frequency of occurrence and significance of difficulty) do you rate the following problems?

Persistent skin allergy from use of surface electrodes

0 = not a problem

10 = very serious problem

0---------1---------2---------3---------4---------5---------6---------7---------8---------9----------10

Constant difficulty positioning electrodes effectively

0---------1---------2---------3---------4---------5---------6---------7---------8---------9----------10

Difficulties donning and doffing equipment

0---------1---------2---------3---------4---------5---------6---------7---------8---------9----------10

Difficulties in managing the wires and footswitch

0---------1---------2---------3---------4---------5---------6---------7---------8---------9----------10

Continuing discomfort from sensation of stimulation

0---------1---------2---------3---------4---------5---------6---------7---------8---------9----------10

 

  1. Patient selection

Considering the above problems, would you consider that the advantages of an implanted dropped foot stimulator outweigh the potential clinical costs (risk due to anaesthetic, invasive procedure) in the following cases?

All patients with dropped foot. Yes / No

Those who, after using a surface system for some time, demonstrate a long term need for dropped foot correction.Yes / No

Those who experience the above problems. Yes / No

Those who are prevented using a surface stimulator by the above problems. Yes / No

Those who are prevented using a surface stimulator by the above problems and do not benefit from an AFO. Yes / N

Please specify which patient groups you would consider the implanted dropped foot stimulator appropriate for: (please place two ticks in the appropriate box if you think an implant would be justified. Put only one tick if you think it would be justified in limited circumstances only.)

 

CVA

Multiple Sclerosis

Spinal cord injury

Cerebral palsy

Traumatic head injury

Over 70 yrs.

 

 

 

 

 

50 – 70 yrs.

 

 

 

 

 

18 – 50 yrs.

 

 

 

 

 

 

  1. About you:

Name: __________________________________

Occupation: __________________________________

Have you attended the Salisbury Introductory FES course? Yes / No

Do you regularly prescribe or refer patients for the ODFS? Yes / No

Please add any further comments below.

 

Thank you for taking the time to complete this questionnaire. Please return it in the stamped addressed envelope provided.


Disclosure of personal details

If you are a registered FES practitioner (attended the Salisbury FES Course) we would like to be able to supply your name and work address to people seeking treatment in your area. This information will not be used for any other purpose.

 

I agree* / do not agree* that my name and work address can be supplied to people seeking FES treatment in my area

*Please delete as appropriate.

 

Signed: __________________________________________________ Date: ____________________

 

 

Print name: __________________________________________________


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