Contents

The Wessex Rehabilitation Association
Setting-up new FES clinics at Regional Hospitals
The Action Research Grant
New stimulators
A history of FES at Marie Therese House 1988 - 1998
A case history of Patient ‘M’
FES - into the next millennium
Forthcoming courses and lectures

Editorial

This is the second Salisbury FES newsletter and there is plenty of news! We have made great progress over the last six months. Following publications in Clinical Rehabilitation, Physiotherapy, and Artificial Organs and continuing media coverage more and more patients are being referred to Salisbury for treatment. The need for patients to be treated in other centres, nearer to their homes, is becoming acute. This of course is good news but makes it even more important for us to set up centres and train more physios in using FES so that it can become part of their clinical practice.

To this end we have continued to run the two day training courses and have planned a number of half day introductory workshops and lectures to specialist interest groups such as ACPIN. In addition, with the benefit of a generous grant from the Wessex Rehabilitation Association (WRA) we have been able to fund a half time physiotherapist to set up FES centres at regional hospitals, in a similar way to Christine Singleton’s unit in Birmingham. A number of people have expressed interest in pursuing this more thorough training and as we can only set up three in the first 18 months it is important for us to select carefully to ensure that the units we set up will continue and thrive after the training period ends. There has been a lot interest, but we have not made a definite decision about where the units will be. If you would like to be considered contact us NOW.

Other important bits of news:

Sadly Anna Dunkerley who has worked in the department for the last year, while she has been studying for her MSc in Rehabilitation Studies at Southampton University, is leaving in December. She has been a tremendous asset to the department and we, and our patients will miss her very much.



The Wessex Rehabilitation Association

John Hutchings

The Association was founded some 30 years ago, by Professor Hugh Glanville, to promote the employment of disabled people. This was at a time when social benefits were more limited and disability often caused sever economic hardship and consequences. The WRA provided practical and financial assistance to help people in their recovery and to achieve an improved quality of life for those who have to live with some form of permanent disability.

Initially the emphasis was on the provision of work and assistance into the employment environment. However such roles have largely been taken over by the Public Sector involvement in Social Services and after-care medical requirements. There was also, throughout this period a growing awareness of employee disablement problems by their employees and the need to address these.

Legislation has steadily increased the requirements to provide adequately for disablement conditions both in the physical environment but also the extent to which it is incumbent upon society to be helpful and assisting. The recent Disability Discrimination Act introduced requirements which were unheard of in the 1960’s. We often forget how far we have come, in what is a relatively short time.

The ‘Wessex’ connotation is not a literary reference to Hardy’s novels, but relates back to the original Health Authority area. The Southwestern area does not manage to have quite the same ring about it!

However, the Association had two notable achievements in more recent years, largely under the stewardship of John Gisby. Arising from appeals and fund raising activities the Glanville Centre was built. This now houses Laing Laboratory, with its specialist burns research unit and also the Medical Physics and Engineering Department, with a strength exceeding thirty. Additionally the Tissue Viability Society was created as a separate entity and is now carrying out valuable and increasing work.

The work of the Medical Physics Research team in Salisbury, is broadly in four areas.

The WRA has recently redefined its objectives as -

Fund raising for NHS related activities is never easy, but WRA has made some progress to the point where we are pleased to be assisting in the appointment of an additional physiotherapist to work on increasing the usage of FES.

We are also examining the feasibility of establishing local support groups in those areas where FES is known and its advantages will be perceived.

The new role of the Wessex Rehabilitation Association (WRA)

Physiotherapists using FES have often encountered problems funding the cost of Stimulators and equipment. Frustratingly they can often secure an Extra Contractual Referral (ECR) but, having done the FES course, they understandably want to treat their own patients rather than continue to refer them to Salisbury.

We feel that the following proposal may solve the problem. It has been our experience that, while hospitals are unwilling to purchase equipment, they will often agree to loaning it. In addition, some patients may be happy to pay for the use of a stimulator and the consumables themselves rather in the way that many people pay for the supply of contact lenses and the associated consumables.

We are therefore setting up a loan scheme for the supply of stimulators and consumables. This will not affect the existing service for patients whose treatment is funded by an ECR which includes the cost of maintenance and consumable or centres who wish to continue purchasing stimulators outright except that the supply will be administered by the Wessex Rehabilitation Association (WRA). There will be no change in addresses or telephone numbers, supply or availability of products or the cheerful, knowledgeable service you have become accustomed to!

The way the system will work

Any accredited user (those who have completed the two day FES course) can, on behalf of their patient, acquire a stimulator and supply of consumables, including foot-switches through the lease scheme.

The ownership of stimulators acquired through the lease scheme will remain with the supplier (usually Salisbury).

Payments will be monthly and for an ODFS will be £35 per month for the first year and £20 per month for subsequent years. Basically this means that 95% of the cost of the stimulator is paid in the first year, in subsequent years the repayment covers the cost of consumables and maintenance.

Stimulators will continue to be supplied only to accredited users and the responsibility for payment whether outright or through the loan scheme will be the accredited user, Health Authority, GP fundholder etc. It is our intention that they should be able to pass the cost of loaning the equipment to the patient when this is appropriate.

Changes relating to CE marking

From 1/6/98 we will have to comply with EC regulations regarding the manufacture and supply of electronic medical equipment.

From 1/6/98 all stimulators will be CE marked and therefore records must be kept of their subsequent usage and ownership.

The manufacturing records for all stimulators will be kept in Salisbury.

Centres that purchase FES equipment will need to keep their own records of subsequent usage.



Setting-up new FES clinics at regional hospitals, an eighteen month training programme

The two day training courses (six have been organised so far, training over 60 therapists), allow therapists to purchase stimulators and it was intended that, after completing the course they would be able to practise basic FES techniques with their patients. Although the courses have succeeded in making therapists aware of the uses of FES and enabled them to identify suitable patients, they have not, except in a few cases, succeeded in providing sufficient training to enable therapists to use FES confidently and independently. The skills needed to use FES effectively are best acquired by the physiotherapist in training treating a variety of patients under the supervision of an experienced therapist.

A grant has been awarded to the department by the WRA to fund, initially for eighteen months, a 0.5 WTE physiotherapist to set up clinical FES services at regional hospitals.

It is our intention to do this in the following way:

The Physiotherapist employed on the grant will train the lead physiotherapists in the selected centres by working closely with them and their patients.

Four, one day, clinics will be run at each centre in the first year.

Patients who have been identified as suitable will be assessed and treated at the clinics.

FES equipment and consumable (electrodes foot-switches etc.) will be sold or leased to the participating hospitals.

At the end of the year the trained physiotherapist should be able to use FES effectively as part of clinical practice and be able to continue to run the FES clinic in that centre. It is of course vital that the hospital or department continue to purchase or lease FES equipment and a system for ensuring this will need to be agreed at the start.

Cost to the participating hospitals:


Model for this proposal:

City Hospital, Birmingham has been the model for this method of training, Christine Singleton described her experiences in the last Newsletter. Dr Steve Sturman, Consultant in Rehabilitation, initiated the process. Over the period of one year he had referred approximately 12 of his patients for FES treatment in Salisbury, through the ECR system. This was expensive, not only for the Health Authority, but also for the patients who had to travel from Birmingham and often stay overnight in Salisbury. Senior Physiotherapist, Christine Singleton, supported by the therapy manager Wendy Parton, organised a two day course in Birmingham but, following this, felt that she and her colleagues were not sufficiently competent to use FES without further training. Training was therefore provided in the way described and City Hospital, Birmingham, are now independently providing FES treatment for all their suitable patients and are accepting ECR referrals from other Health Authorities so providing additional income to support the service. They continue to purchase FES equipment from Salisbury, but will have option of using the leasing service when it is set-up.



The Action Research Grant

A pilot trial to determine control algorithms and patient selection criteria for two-channel stimulation. Duncan Wood (Clinical Engineer)

Christmas came early for us in Salisbury! After spending all of this year, and a good part of the last, chasing funding to progress the next stage of a two-channel dropped-foot programme, we have now been successful in obtaining a full grant for eighteen months from the Action Research charity.

This continues our clinical research, where we are seeing more and more patients who we feel would benefit from stimulation of a second muscle group. Many of you would have either come across or used the two-channel stimulator developed at Salisbury District Hospital, but fewer would know of the collaborative work we have been undertaking with Dr David Ewins at the University of Surrey since 1993.

As part of this work, a programmable two-channel stimulator, the Compustim-10B, has been developed. Each stimulator can be programmed to meet an individuals requirements, by setting stimulation and timing parameters via a user-friendly software package. This enables clinical staff to try different algorithms, and therefore different muscle groups, so that the patient can get 'maximum benefit’ from the stimulator. Currently, as with our single-channel Odstock Dropped Foot Stimulator (ODFS), foot switches control the stimulator. In the early work with this stimulator, we tried four different algorithms with patients: bilateral dropped foot, dropped foot with hamstrings for improved knee flexion, dropped foot with gastrocnemius for improved push-off and dropped foot with triceps for inhibition of associated reactions to improve balance. The algorithms chosen for each patient were from clinical observations. The results from this preliminary study were promising, but it needed to be progressed into a more controlled study.

This new grant, to start in early 1998, is to select twelve patients currently using the ODFS who we feel may benefit from a second muscle group being stimulated. As part of an ABA trial, these patients will be set up with a Compustim-10B and the algorithm selected according to the current criteria we have been using in the past, i.e. clinical observations alone. The trial will address whether two-channel stimulation using the Compustim-10B has a functional benefit compared to the use of a single-channel and whether there is a re-educational effect not seen when using the ODFS. All subjects will be assessed both clinically and by detailed gait analysis techniques at Southampton General Hospital. The latter will hopefully be used to shed some light on three important questions we currently face in assessing patients for two-channel stimulation. Firstly, are we correct in our selection of the patients who may benefit from a second channel. Secondly, are we selecting the optimal algorithm for each patient. Thirdly, can we select and fine tune a patient’s algorithm by simple clinical assessment alone or do we need to use a more detailed assessment, such as gait analysis.



New Stimulators

Paul Taylor (Clinical Engineer)

4 Channel Stimulator (04CH ex)

The old 4 channel exercise stimulator design was beginning to show its age. It was particularly fiddley for us to make and then prone to unreliability. Additionally, I had been asked for several modifications to stimulators in order for them to perform various jobs. It was decided to construct a new stimulator which would include some of the modifications and using techniques that would enable easier construction and therefore better reliability. A set of trimmer controls, accessible from the battery compartment as in the ODFS, have been added that allow adjustment of the following parameters:

Frequency 12 - 50 Hz
Pulse width 100 - 450 µS
Period time 12 - 60 S
On time 2 - 12 S
Ramp time 0 - 9 S

The pulse width control can be used to limit maximum stimulation strength, for all 4 channels (strength of contraction is proportional to the pulse width). Therefore low pulse widths should be chosen for the muscles of the hand and arm, longer pulse widths for the lower limb. The ‘On’ time is the duration of the contraction while the ‘Period’ time is the time taken for the stimulator to complete one cycle (contraction period for both sets of channels plus rest periods). By choosing a short ‘On’ time and a long ‘Period’ time there will be a long rest period between contractions. The minimum rest period is two seconds and can be achieved either by reducing the ‘Period’ time or by increasing the ‘On’ time. Ramp times can be chosen independently for channels 1 and 2 and channels 3 and 4.

The output of the stimulator has been increased to 110 mA and, with the increased pulse width, makes the output sufficient for the large muscles of the leg in most patients. Like the old 4 channel stimulator, switches allow the user to decide whether channels 1 and 2 are active independently or are active with channels 3 and 4. In this way 2 channels can alternate with 2 channels, 3 with 1 or 4 with none.

The stimulator can be controlled by a foot pedal. This device allows the pulse width of all channels to be increased or reduced by the therapist thereby controlling the strength of the contraction and leaving the hands free to manipulate (!) the patient. When the foot pedal is pushed all the way down, the channels that are active swap over with the non active channels so that, for example, a flexion pattern can be alternated with an extension pattern. The pedal can also be used by the patient for functional activities or to exercise independently.

The new 4 channel stimulator replaces the old one and is £280. The pedal is an optional extra and is £50. The prices will be reviewed next April.

A New ODFS

The existing ODFS has been in service now for two years and on the whole has been reliable and successful. However there are some problems with the existing unit:

Skin allergy. Although a less common problem than earlier due to improved cleanliness and use of electrodes, some users still have an allergic reaction to electrodes due to electrochemical effects. This seems to be eliminated with a symmetrically bi-phasic output. i.e. for every positive pulse there is an equal, opposite polarity pulse. However, this means that there is no longer an active and indifferent electrode.

Foot flap (or walking duck according to Penny Bell). EMG recordings of the anterior tibial muscles show that peak muscle activity occurs at heel strike and activity continues until flat foot. This is because the anterior tibial muscle lowers the foot to the ground, braking against the effect of gravity. The ODFS output ends at heel strike and therefore the foot can some times strike the floor rapidly in the manner of a duck. This can be reduced to some extent by the down ramp but experience with the Compustim 10B on the Action Research project showed that it is more effective to continue the stimulation for a short fixed time after heel strike.

Fine control. The output control (dial) on the existing ODFS alters the amplitude of the current. Because of the design of the stimulator it is not easy to make a fully linear change in output by adjusting the dial. This means that a small adjustment of the dial can produce a bigger than expected change in output making adjusting the level of stimulation fiddley. It is however easy to make a linear change in pulse width with the resulting smother adjustment of level of stimulation.

Output power. Occasionally I have been asked to modify stimulators to increase output power.

Battery connections. These can some times be unreliable.

Construction. The old ODFS uses old style components which are difficult to use in automated construction processes.

On / Off switch. Often users of the stimulator have complained about having to turn the stimulator off when they sit down and then find the correct level when starting to walk again. This was a design feature, intended to stop users from inadvertently adjusting the output when off, causing the stimulator to give an unexpectedly high level when it is turned back on. If a means of preventing the output from being adjusted to a high level, it would be feasible to use an on off switch.

The new ODFS III (mark 5!) is in the same box as before with the same front panel layout. The output control now adjusts the pulse width from 0 to 400 µS. The internal controls now consist of 5 trimmer controls and a block of 4 switches. Two switches have the familiar function of selecting heel strike or rise and adaptive or fixed timing while the two new switches which are ganged together, select bi-phasic or mono-phasic output. It is intended that bi-phasic be used where possible but mono-phasic would be available when high power is required or when the effect of polarity is required, for example, to achieve greater eversion etc.

Three of the trimmer controls are as before i.e. time, rising edge ramp and falling edge ramp. The additional trimmer next to the time control allows an extension period to be added between 0 and 1.5 seconds. The final additional trimmer replaces the high power / low power switch and allows adjustment of the output current from 30 - 110 mA. The intention is that the current is adjusted so that a comfortable contraction is obtained with the output control on about 7. This allows a little head room to turn up the stimulator as required but prevents excessively strong contractions that may be painful.

The final addition is a pressure sensitive switch mounted on the back of the stimulator. This acts as a toggling on / off switch. The stimulator is turned on in the normal way by rotating the dial. To put the stimulator in to "sleep" mode the pressure sensitive switch is pressed. This can be done in an approximate sort of way, say using the back of the hand, so would be easy for people with poor hand function. To start the stimulator again, the switch is pressed a second time. When the stimulator is in sleep mode, a small amount of current is still being used so it is important to turn the stimulator off with the dial when the stimulator is not used for a long period. Use of the switch is only permissible because the maximum output current can be adjusted to prevent large changes in output levels.

The new ODFS has been designed using surface mount technology to allow easier manufacture. We have also designed an improved battery connector. We are currently investigating the possibility of getting all our devices made outside Medical Physics to ensure we can keep up with demand. However we will retain the distribution of the stimulators, only supplying to people who have attended the ODFS course. We also have to make sure that they comply with all EC regulations by next June so we can apply the CE mark which is necessary to continue supplying medical equipment after that date.

The stimulator is currently under trial in Salisbury and so far has been received favourably. It's still early days. If you have any comments on the design of this or any other stimulator, we would be pleased to hear them.



A history of FES at Marie Therese House 1988 - 1998 (From the Ridiculous to the Sublime)

Pauline Whitham

I was first introduced to FES in 1987 when I was appointed Senior I Physiotherapist at Marie Therese House. This is a Unit for the young disabled at St Michael's Hospital, Hayle, Cornwall. (Hayle almost falls off the map not far from Lands End.)

A group of young male patients, all with spinal cord injuries, at varying levels, some complete and some incomplete, had investigated FES with the idea it could help them to stand and eventually walk. They had made contact with an engineer in Wales who was selling muscle stimulators.

Well, what a strange scenario! This project had no local medical cover and there was no structured assessment protocol. What was I to do?

(I can't resist telling you that the patients were using wallpaper paste instead of conductive gel because it was cheaper!)

Fortunately, exactly one month after my appointment we were approached by the Medical Physics Department of Odstock Hospital, Salisbury. A visit was arranged and I was delighted and very relieved to meet Dave Ewins, Paul Taylor and Dr Ian Swain.

A safe standing programme for paraplegic patients was set up with full approval from Dr Chris Evans, Consultant in Rehabilitation for Cornwall. Regular visits to Cornwall were arranged, mainly because we had a group of enthusiastic, compliant patients. I did wonder why their research led them to Cornwall when their own Spinal Injuries Unit was a few yards down the corridor. Apparently, the policy adopted for acute spinal cord injury did not include FES.

We had good results with a few very dedicated patients and began to get noticed by the media. In 1991 our Unit was included in a BBC 1 documentary "The Thrower Report". The programme was called "Who can help my body and who will pay?".

Alongside the Safe Standing Project, which was led by Dave Ewins, was the beginning of serious research into Dropped Foot Stimulation. The Team from Salisbury realised that FES could help not only a few elite spinal injured patients, but a huge number of people struggling with mobility following a stroke or suffering with multiple sclerosis.

Once again Marie Therese House could offer the ideal clientele. The Physiotherapy Department, I am glad to say, had changed enormously and was staffed by Bobath trained neuro-physiotherapists. However, our patients were extremely fortunate in that we could offer them additional techniques to help them with gait re-education.

Those patients involved in the Dropped Foot Stimulation Research realised they were pioneers and once again were extremely compliant. The ODFS has become more sophisticated and reliable and on looking back through records I note we have been able to help 63 patients to walk more safely and for longer distances. Many of our patients using the ODFS have multiple sclerosis and may deteriorate beyond useful walking but I suggest we have probably enabled them to stay mobile for at least two years longer than they would otherwise have managed.

Jane Burridge subsequently joined the Medical Physics Team in Salisbury and has enhanced the engineer's concept of firstly normal movement and then abnormal movement which results in disability. It was interesting to note at last year's FES Conference in Salisbury that Ian, Paul and Jane have a unique Medical Physics Department in that they have regular clinics with patients travelling from a wide area via extra contractual referrals.

Our close links with Salisbury remain very strong and when I relinquish my post at Marie Therese House in March 1998, I hope to obtain funding to develop the use of the ODFS throughout Cornwall and possibly Devon. I would like the funding to allow enough money to train other neuro-physiotherapists in the region. Our colleagues seem to show some reticence in the use of the equipment and their fears need to be allayed.


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