New Research Projects
An investigation into the effect of Functional Electrical Stimulation on the mobility and quality of life of people with Multiple Sclerosis.
Funded by the MS Trust
2 years from Feb 2003
Although FES has been used to assist mobility in MS for many years, there has never been a published a randomised controlled trial to demonstrate its effectiveness. Increasingly great emphasis is being placed on the need for evidence based health care, particularly when funding of treatment is involved. We are therefore performing a RCT (Randomised Controlled Trial) of the ODFS in people who have a dropped foot due to secondary progressive MS.
Main Hypothesis: The Odstock Dropped Foot Stimulator is an effective orthoses indicated by an increase in walking speed when it is used
Secondary Hypothesis: Use of the Odstock Dropped foot Stimulator will reduce the effort of walking, will reduce the incidence of falls and will improve the quality of life of those who use it.
Research subjects will be randomly allocated to a treatment group who will receive the ODFS and physiotherapy gait advice and to a control group who will only receive the physiotherapy gait advice. Both groups will receive the same assessments and contact time. Using 10 m walking speed data from our clinical practice, power calculations show that we require 25 individuals in each group to demonstrate an improvement in walking speed of 20% when the ODFS is used.
On the first day all research subjects will be assessed prior to randomisation. After randomisation they will either be taught how to use the ODFS and given appropriate physiotherapy gait advice or just given advice. Each individual will then be followed up three days later to re-enforce the information given on the first day. They are then followed up at 6 week intervals till the 18th week when the trial ends. Control group subjects will be given an opportunity to try the stimulator at the end of the trial.
Assessments:
Walking speed over 10m, Physiological Cost Index, Six minute timed walk, Modified Ashworth Scale, Rivermead Mobility Index, The Multiple Sclerosis Impact Scale (MSIS- 29), User Opinion Questionnaire, Falls Diary, Canadian Occupational Performance Measure (COPM), Hospital Anxiety and Depression scale.
Paul Taylor and Geraldine Mann
A Pilot Study to investigate the effects of Functional Electrical Stimulation on gait in Parkinson’s Disease.
Funded by the Parkinson’s Disease Society of the United Kingdom
Feb 2003 to Feb 2004
Introduction
An important aim of physiotherapy for patients with (PD) is re-education of safe and efficient gait. Patients frequently develop a shuffling gait with reduced speed, stride length and heel strike. Disease progression may give rise to ‘freezing’ when attempting to initiate or maintain gait. There is a high risk of falls in these patients. Functional Electrical Stimulation (FES) uses electrical impulses to stimulate nerves supplying weak or paralysed muscle and is most commonly used to correct dropped foot in patients following stroke. Previous studies have demonstrated a positive effect on parameters of walking when visual, auditory or cutaneous sensory ‘cues’ are used. It is hypothesised that FES may improve walking in PD through both its motor and sensory effects and thus improve quality of life for patients.
Method
10 subjects with idiopathic PD who have problems with walking and ‘freezing’ will be recruited for treatment with FES to the common peroneal nerve of their more severely affected side. Stimulation will be delivered by the Odstock Dropped Foot Stimulator (ODFS). Assessments of walking pattern, speed, effort and endurance will be carried out. Episodes of ‘freezing’ and quality of life measures will be recorded.
Future Work
The results obtained will, if positive, be used to design a more extensive trial of the use of FES with this patient group.
Geraldine Mann and Stacey Finn
Trial of the Finetech Implanted Dropped Foot Stimulator following incomplete spinal cord injury
Funded by INSPIRE
1 year from spring 2003
The incidence of incomplete Spinal Cord Injury (ISCI) is estimated at 17 per million of population per year, about 65% of all spinal cord injuries. In recent years the incidence has risen in comparison to complete spinal cord injuries, mainly due to improved care in the acute stage of the injury. Within this group there is a wide spectrum of disability ranging from functionally normal individuals to those that are profoundly disabled. Many individuals are able to achieve walking but with significant gait deficit, the most significant factor being a dropped foot, the inability to lift the foot as it is swung forward in the swing phase of gait.
The Odstock dropped foot stimulator has been successfully used with many people who have an ISCI. It has been demonstrated that walking speed and mobility are improved by the device.
However, there are some problems using skin surface electrodes. It is often difficult to correctly locate the position for the electrodes and it can be time consuming for the user each time they put the device on. The skin can also react to the electrodes, coursing a skin irritation. Finely the sensation of the electrical stimulation can be quite strong which can discourage some potential users.
The Fineteck Implanted Dropped Foot Stimulator avoids these problems by locating electrodes directly on the nerves that produce the movements. Internally there is a small receiver stimulator with two leads connecting to the electrodes. Externally the user wares a transmitter box that passes power and control signals to the receiver by radio telemetry. The device is timed to walking using a foot switch placed inside the shoe. When weight is taken off the switch, stimulation starts and the foot is lifted. Stimulation stops when weight is returned to the switch.
The device has been used in ten people who have had a stroke and found to be safe and effective. We now wish to perform a trial with people who have had spinal cord injuries to see if they may also benefit from its use. Three centres, Stoke Mandeville, Southern General and Salisbury, will be part of this project, each recruiting seven subjects. Each subject's suitability for FES will be determined by using and skin surface FES system for three months. If they respond well they will go on to use the implanted device. Assessments will be made to determine the effect on walking speed, walking effort, walking endurance, falls, disability and quality of life. This application requests funds for the Salisbury part of the trial at a cost of £22,952.60.
Paul Taylor, Anba Soopramanien and John Hobby