Department of Medical Physics and Biomedical Engineering

Salisbury District Hospital,

Salisbury, Wiltshire

SP2 8BJ, U.K.

Telephone (01722) 429121

Fax (01722) 425623

Email enquiries@mpbe-sdh.demon.co.uk

PATIENT INFORMATION SHEET

July 2002 V0.0

You are being invited to take part in a research project. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Please ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

 

Project title: An investigation into the effect of Functional Electrical Stimulation on mobility and quality of life in people with Multiple Sclerosis.

A short title for the project is, MS FES Project

What is the purpose of the project?

In multiple sclerosis (MS), many people are left with some degree of movement disability that is often characterised by a dropped foot. This is the inability to lift the foot as the foot is brought forward, often causing it to drag along the ground. By applying electrical pulses (Functional Electrical Stimulation, FES) to the appropriate leg muscles, the dropped foot can be corrected during walking.

The Odstock Dropped Foot Stimulator (ODFS), developed at Salisbury District Hospital, is a medical device that can cause foot lift by sending electrical pulses through the skin to stimulate the appropriate nerve. Electrodes are placed on the skin at the side of the leg near the knee and on the front of the leg. The device is switched on and off by a small switch placed on an insole in the shoe. Electrical pulses are sent to the electrodes as weight is taken off the foot on the affected side, and finish as the affected side takes weight again. Therefore, the electrical pulses, or stimulation, is applied as the affected leg swings through while walking. Electrical stimulation feels like pins and needles and is well tolerated by most people.

The ODFS is about the size of a pack of playing cards and can be clipped to the belt or carried in a pocket. It is powered by a standard pp3 9V battery, which lasts about 3 weeks. The cables are worn discreetly under clothing and the foot switch is placed on the under side of an innersole, allowing it to be transferred between shoes.

While the ODFS has been used by many people who have MS and many have reported benefits from its use, no formal trial of the device has been performed. The purpose of this project is therefore to produce definitive evidence for the clinical use of the device by performing a randomised controlled trial. In this type of trial suitable candidates are first selected and then randomly allocated to a treatment group who receive the ODFS or a control group who do not use the ODFS but will receive advice on walking from a physiotherapist. Both groups are assessed using the same measurements and the difference between the two groups will indicate the success of the treatment.

 

Inclusion Criteria: Diagnosis of secondary progressive MS determined from the clinical history

A rating of 4-7 on the Kurtze Expanded Disability Status Scale (This is a standardised scale used to classify the extent of a persons MS)

Dropped foot impairing mobility

No previous use of FES

Good response to common peroneal stimulation

Passive ankle dorsiflexion to at least plantigrad (ankle to 90 degrees)

Ability to understand and comply with the study requirements.

At least 18 years of age

Live within 100 miles of Salisbury District Hospital

 

Exclusion Criteria: Cognitive or psychiatric problems affecting subjects’ ability to understand or comply with treatment procedure

Any other neurological condition or orthopaedic problem that may affect response to treatment

 

Do I have to take part?

No, it is up to you to decide whether or not to take part. If you do decide to take part you will be asked to sign a consent form. During the project, you are free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive from Salisbury District Hospital.

 

What will happen to me if I take part?

You will first be given an appointment for an assessment. At this appointment the trial will be explained to you and your suitability assessed. You will not be pressed for an answer straight away but allowed time to make a decision. If you require further information you will be able to speak to research team members by telephone in this period.

Once you have agreed to take part in the project and have signed the trial consent form you will be asked to attend the hospital on 2 consecutive days for the start of the project. On the first day you will be allocated to the treatment or control group. This is done using random numbers generated by a computer and is administered by an independent 3rd party. The researchers have no influence in this procedure. If you are allocated to the treatment group will be taught how to use the ODFS. On the second day your ability to correctly use the ODFS will be checked and there will be an opportunity to ask any questions you have about its use. Further instruction in the use of the ODFS will be given if necessary. Measurements will then be made of your walking. If you are allocated to the control group, you will be given advice by a physiotherapist to help your walking. On the second day the same measurements will be made.

Whichever group you are allocated to you will be asked to attend for repeat assessments 6, 12 and 18 weeks later. If further advice is needed on the use of the ODFS or about walking, this can be given at these appointments or at any time by telephone.

The following assessments will be made:

Facilities will be available to ensure privacy when changing, placing electrodes or measurement equipment. Where necessary, chaperones will also be provided.

 

How long is the project?

The project lasts 18 weeks. In this time you will be asked to attend Salisbury District Hospital 5 times. Additionally, you will attend for an assessment before the trial begins. You can claim back travel expenses for these hospital visits.

 

What are the alternatives for treatment?

Alternative treatments to correct dropped foot are splints worn around the ankle to control movement.

 

What are the possible disadvantages and risks of taking part?

There are no known side effects from using FES, but there are some minor risks.

First, the stimulation feels like pins and needles. Most people quickly become used to it, but it is possible that you may find the sensation too uncomfortable and may decide to stop using the stimulator. Similarly, if you do use the stimulator, then turning the stimulation up too high may be uncomfortable, but not dangerous.

Secondly, some patients develop an allergic skin reaction to the electrodes. If this happens, then you are asked to contact us. We will provide advice on how to solve this problem.

 

What are the possible benefits of taking part?

While it is known that this type of therapy is safe to use, it has not yet been scientifically proven that it is effective for people who have MS. As with any new medical technique it is necessary to prove that it is effective before it can be more widely introduced. The information we get from this project may help us to improve our treatment, and therefore improve the walking ability and quality of life of other people that have MS.

 

What if new information becomes available?

Sometimes during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, we will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw we will make arrangements for your care to continue. If you decide to continue in the study you will be asked to sign an updated consent form.

With your permission, we will contact your doctor and, where appropriate, your medical consultant before you start on the trial. If you do start the trial and there is any new information from your doctor, consultant or one of the researchers that could affect you continuing on the project, we may ask you to withdraw from the project. In reaching any decision we will discuss it fully with you and consider your best interests at all times.

 

What happens when the research project stops?

At the end of the project, if you are in the treatment group and you think the ODFS is of benefit to you, funding will be applied for to continue the use of the stimulator under the NHS. Your use of the ODFS will be supported by the Department of Medical Physics and Biomedical engineering while this application is in progress. If you are in the control group and wish to use the ODFS, again funding will be applied for and your treatment begun once funding is agreed. In many cases funding will already be in place before staring on the trial.

 

What if something goes wrong?

If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds for a legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this project, the normal National Health Service complaints mechanisms will be available to you.

 

Will my taking part in this project be kept confidential?

All information collected about you during the course of the research will be kept strictly confidential. Each patient on the project will be given a unique code that does not contain any personal details. All data collected will be anonymised and confidentiality will be maintained at all times.

In the consent form, we will ask for your permission to allow restricted access to your medical records. This access will only be by the named researchers who are members of NHS staff within this department.

 

What will happen to the results of the research project?

The results we obtain from the measurements at each appointment will be used to evaluate the effectiveness of the treatment and direct future clinical trials and FES treatment. A report will be submitted to the MS Trust charity that is funding this work. Findings may also be published in scientific and medical journals, at conferences and at training days for clinicians. Confidentiality and patient anonymity will always be maintained. If you are interested, we would be pleased to discuss the results and conclusions from the project with you.

 

Who is organising and funding the research?

The project is funded by the MS Trust charity. The money is to cover research expenses associated with the project, including part of the salaries of the named research staff. No payment is made to your referring doctor.

 

Who has reviewed the project?

This project has been reviewed by Salisbury Research Ethics Committee, Wiltshire Health Authority, Southgate House, Pans Lane, Devizes SN10 5EQ. Tel: 01380 728899

 

Contact for further information

If you need further information about the project, please contact one of the following:

All three are staff in the Department of Medical Physics and Biomedical Engineering, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ. Tel 01722 429065. E-mail enquiries@salisburyfes.com web page www.salisburyfes.com

For information about the arts project being run in conjunction with this trial click on Face to Face.

Thank you for reading this information sheet.

If you wish to participate in this project, please either telephone or write to us at the above address.