Re-education of arm and hand function following stroke

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).

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 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).