Specialty: Stroke, Primary sub-specialty: Rehabilitation
Conditions
Interventions
Participants are randomly allocated to one of two study groups in a 1:1 ratio using a computer generated randomisation system will be used to randomise participants via a central telephone service hos
Sponsors
Northumbria Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over 2. More than 48 hours but less than 3 months post stroke onset 3. New reduced upper limb function on one side. 4. Able to provide individual consent to participate in the study. 5. Living within the community services catchment area of a participating study centre 6. Receiving at least twice weekly NHS therapy which is planned to continue for four weeks from the start of the intervention
Exclusion criteria
Exclusion criteria: 1. Severely reduced upper limb function which results in inability to lift the affected hand off the lap when sitting 2. Unable to follow the programme due to significant cognitive impairment or communication difficulties 3. Other significant upper limb impairment e.g. fixed contracture, frozen shoulder, severe arthritis, upper limb pain that inhibits participation in the programme 4. Diagnosis likely to interfere with rehabilitation e.g. registered blind, severe visual problems as a result of stroke, palliative treatment approach being provided 5. Unable to sense both Cues device vibratory prompts and visual display
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcome measures: 1. Recruitment is measured by enrolment of one patient per month from each study centre 2. Attrition rate is measured by the number of participants who consent to participate in the study and remain in the study until the end of the 8 week follow up assessment. 3. Participant adherence to the study is measured by participants wearing the wristband for >80% of the recommended hours 4. Report on the frequency of usual rehabilitation care received is measured by completion of daily log sheets 5. Success of outcome assessor blinding as measured by the number of participants who complete the 4 week outcome assessment without unblinding the outcome assessor to participant group allocation. 6. Report on serious adverse events related to the study as measured by completion of the SAE report forms 7. Completeness of data will be measured by completion of baseline, 4 week and 8 week assessments and number of complete days of accelerometer data from the wristband | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical outcomes will be recorded at Baseline, 4 weeks and 8 weeks: 1. Stroke impairment and dependency, measured by the Modified Rankin Scale, Barthel Index and National Institutes of Health Stroke Scale (NIHSS) 2. Upper limb pain and overall fatigue, measured by a numerical visual analogue scale (0-10) 3. Upper limb function, measured by the Action Research Arm Test 4. Real world upper limb activity, measured by the Motor Activity Log 5. Upper limb strength, measured by the Motricity Index 6. Objective measurement of affected upper limb activity, measured by a standard wrist worn accelerometer worn for three days after the 4 and 8 week outcome visits 7. Unilateral spatial neglect, measured by the star cancellation test | — |
Countries
United Kingdom
Contacts
Public ContactRuth Da Silva
Outcome results
None listed