Stroke more than 6 months post-cerebrovascular accident (CVA) Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Intervention group:
Functional electrical stimulation of the wrist, finger, thumb and elbow extensors, triggered using a movement sensor (an accelerometer) detecting an attempt to reach forward to gra
Sponsors
Salisbury NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. First stroke leading to hemiplegia 2. Aged 18 years and above (no upper age limit), either sex 3. Reduced hand and arm function, limiting voluntary elbow extension and hand opening 4. Medically stable 5. Able to understand and comply with assessment procedures 6. Able to give informed consent 7. Minimum 45 degrees active shoulder flexion 8. Able to initiate elbow extension 9. Enough active wrist and finger extension to pick up and release a 2.5 cm cube (easiest task in grasp section of Action Research Arm Test [ARAT]) 10. Responds to stimulation to open the hand
Exclusion criteria
Exclusion criteria: 1. An ARAT score of greater than 40 (out of 57) at initial assessment 2. Any existing orthopaedic condition affecting the upper limb 3. Cardiac pacemaker 4. Painful shoulder 5. Fixed contractures at elbow, wrist or fingers 6. Pregnancy 7. Malignancy in the area of the electrodes 8. A history of poorly controlled epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Action Research Arm Test (ARAT). The ARAT was chosen as it includes elements of both shoulder, arm and hand function. Assessments are made at the beginning of the baseline period (-6 weeks) at the end of the baseline (week 0), at the end of the treatment period (week 12) and 12 weeks after the intervention is removed (week 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| Impairment: 1. Fugl-Meyer Test (FM): a measure of impairment commonly reported in similar studies in the literature, so enabling comparison with other trials 2. Modified Ashworth Scale (MAS): to measure elbow, wrist and finger spasticity. Spasticity is a major inhibition to the use of the hand and high tone levels can be distressing. Increased tone would be an indication of an adverse response to treatment. Function: 3. Box and Block Test (B&B): a measure of dexterity. This functional test has been added as it has fewer elements of subjectivity than the ARAT. Activities of daily living: 4. Canadian Occupational Performance Measure (COPM): to assess patient perception of their performance and their satisfaction with activities of daily living Quality of life: 5. Stroke Impact Scale (SIS): a measure of the impact of stroke on quality of life Cost analysis: 6. Cost effectiveness and cost utility: for the cost-effectiveness analyses an appropriate clinical measure will be chosen from the above outcome measures. For the cost-utility study health outcomes will be measured by the health states reported by patients using the EQ-5D questionnaire. These health profiles will be converted to utility values using the published population utility tariffs for the EQ-5D. Costs related to service use incurred by the research volunteers will be recorded using a purpose designed Client Service Receipt Inventory (CSRI) form. Treatment cost will be recorded using case report forms (TCRF) to be completed by the clinical staff throughout the project. Research Volunteer perspective of treatment: 7. Use of Device Questionnaire (UDQ): this custom questionnaire will be used to systematically record the research volunteers' experiences and opinions about their treatment Compliance: 8. Each subject will be asked to complete a compliance diary Safety: 9. Safety will be assessed by recording adverse incidents Assessments are made at the beginning of the baseline period (-6 weeks), at th | — |
Countries
United Kingdom
Outcome results
None listed