Cerebral vascular accident/stroke Circulatory System Stroke
Conditions
Interventions
A randomised controlled pilot study model will be used. 30 people who have had a stroke less than 6 months previously with a Rivermead Mobility Index score between 6 and 10 will be randomly assigned
Sponsors
Salisbury NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants will be over 18 years 2. Participants will be medically fit enough to undertake physiotherapy (consultant and GP approval will be sought prior to starting the trial) 3. Current inpatient stay will be for rehabilitation following first stroke 4. During the inpatient period participants will have demonstrated they have sufficient motivation, memory and cognitive ability to participate in treatment within physiotherapy and practice outside of treatment sessions 5. Patients will be able to understand spoken instructions 6. Participants' goals must include improving gait 7. Suitable patients will be returning home after hospital discharge with a Rivermead Mobility Index of between 6 and 10 8. Participants will be able to attend the hospital for twice weekly physiotherapy i.e. will have suitable transport and live within 25 miles of the hospital
Exclusion criteria
Exclusion criteria: 1. Unable to tolerate sensation of stimulation (assessed prior to acceptance onto the trial) 2. Poor skin condition making stimulation unsuitable 3. Previous neurological conditions likely to influence response to treatment 4. Orthopaedic/other health problems limiting ability to participate or use stimulation/physiotherapy 5. Score of 25 or under on Mini Mental Test 6. Pacemaker and other active implant users 7. Poorly controlled epileptics 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking speed over 10 m assessed at Week 1, Week 8 and Week 20. This has been shown to correlate well with more sophisticated measures of gait and is used routinely in the Salisbury Functional Electrical Stimulation Systems (FES) Clinic for comparison and audit purposes. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at Week 1, Week 8 and Week 20: Walking: 1. Effort as measured by Physiological Cost Index over 10 m. Polar heart rate monitor is used for non-invasive estimation of effort during the walking tests. 2. Visual gait analysis from video by blinded assessor using Rivermead Visual Gait Assessment from video when participants are able to walk sufficient distances. This measure should reflect changes in gait quality. Function: 3. Six-minute walk. This simple test is suggested as way of quantifying change in walking ability with less floor or ceiling effects than walking tests over shorter distances. Six and 12 minute walks have been shown to be responsive to change and useful in documenting gait outcome over an inpatient stay. Participation: 4. Canadian Occupational Performance Measure. This measures change in activities of daily living and assesses self-perceived satisfaction and performance. This outcome measure allows trial participants to focus on relevant personal problems and concerns. 5. Hospital Anxiety and Depression Scale, a widely used indicator of mood. 6. Rivermead Mobility Index to measure changes in mobility and to inform one of the selection criteria. | — |
Countries
United Kingdom
Outcome results
None listed