Topic: Stroke Research Network
Conditions
Interventions
1. A four week RFTP programme for patients with upper limb impairment due to acute stroke OR
2. Usual post stroke rehabilitation
Sponsors
Northumbria Healthcare NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, male and female 2. Within 14 days of stroke onset 3. New reduced upper limb function due to acute stroke but with retained ability to lift the affected hand off their lap 4. Capable of undertaking the RFTP therapy programme and adhering to the study protocol 5. Able to provide informed consent to participate in the study 6. Lives within the community services catchment area of a participating study site
Exclusion criteria
Exclusion criteria: 1. Severe reduced upper limb function which results in inability to lift the affected hand off their lap 2. Unable to follow the RFTP programme for example due to cognitive impairment or receptive aphasia 3. Other significant upper limb impairment e.g. fixed contracture, frozen shoulder, severe arthritis, and upper limb pain that inhibits participation in the RFTP programme 4. Diagnosis likely to interfere with rehabilitation e.g. registered blind, palliative care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to assess the feasibility of a multi-centre, observer blind parallel group randomised controlled trial of a RFTP programme for the upper limb early after stroke. The study design is a pilot randomised controlled trial and interventional. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether it is possible to enrol 1-2 patients per month from each study centre 2. To report the proportion of study eligible patients in each study centre 3. To report the proportion of study eligible patients enrolled in the study 4. To report the main reasons why patients were not eligible for study inclusion 5. To report the attrition of participants in control and intervention groups 6. To report participant adherence to the RFTP programme 7. To report therapist adherence to the RFTP programme 8. To report the usual rehabilitation care received by control and intervention groups within the study intervention period 9. To report the success of outcome assessor blinding to participant group allocation 10. To report adverse events in control and intervention groups during the study 11. To report completeness and summary statistics of data to inform the design of a future multi-centre RCT. Data will be recorded at baseline, 1 and 3 months: 11.1. Upper limb function (measured by the Action Research Arm Test) 11.2. Grip strength (measured using a dynamometer) 11.3. Arm strength (measured by the Motricity Index) 11.4. Ability to perform extended activities of daily living (measured by the Nottingham Extended Activities of Daily Living Index) 11.5. Bilateral arm activity (measured using a GENEActiv™ accelerometer 12. To seek and report the views and experiences of study participants about undertaking the RFTP programme 13. To seek and report the views and experiences of therapists about delivery of the RFTP programme | — |
Countries
United Kingdom
Outcome results
None listed