Stroke Nervous System Diseases Cerebrovascular accident
Conditions
Interventions
Participants will be randomly allocated into 3 groups. The Glasgow Clinical Trials Unit (UKCRC-registered, no. 16) provides a telephone randomisation service for this study. Participants are allocated
moderate: 4 = ARAT = 28
mild: 29 = ARAT = 56) 17. Randomisation takes place after baseline assessments, by telephone to an interactive voice response system to conceal future allocations. A minimisation schedule ensures equ
Sponsors
Glasgow Caledonian University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years 2. Diagnosis of stroke, as confirmed by CT/MRI scans 3. Stoke-related upper limb impairment (score 0-56 on the Action Research Arm Test (ARAT)) 4. Capable of undertaking the allocated physiotherapy intervention and adhering to the study protocol, as per judgement of the treating clinician 5. Able to provide informed consent to participate in the study 6. Living within the community services catchment area of a participating study centre
Exclusion criteria
Exclusion criteria: Any factors likely to interfere with participation in the intervention, including: 1. Medically unstable 2. Severe cognitive/communication impairment (e.g. unable to follow a 2 step command) 3. Severe depression/anxiety 4. Other upper limb impairment: 4.1. Fixed contracture 4.2. Frozen shoulder 4.3. Severe arthritis 4.4. Upper limb pain that inhibits participation 5. Registered blind 6. Terminal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Action Research Arm Test (ARAT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures 1-12 will be assessed at the baseline (3 weeks after stroke), 9 weeks, 16 weeks and at the follow-up (24 weeks): 1. Arm activity in free-living conditions, assessed using body worn triaxial accelerometers 2. Self-reported arm activity, assessed using the 14-item Motor Activity Log (MAL 14) 3. Patient-selected goals and goal attainment, assessed using the Canadian Occupational Performance Measure (COPM) 4. Independence in activities of daily living, assessed using the Barthel Index of Activities of Daily Living 5. Motor performance, assessed during the Action Research Arm Test (ARAT): 5.1. Movement duration 5.2. Trunk movement 6. Grip strength, assessed using a Jamar dynamometer 7. Muscle strength, assessed using the arm section of Motricity Index 8. Mood, assessed using the Hospital Anxiety and Depression Scale (HADS) 9. Self-reported impairment, participation and health-related quality of life, assessed using the Stroke Impact Scale (SIS) 10. Self-reported health-related quality of life, assessed using the EuroQol-5D (EQ-5D) 11. Carer burden, assessed using Caregiver’s Burden Scale 12. Resource impacts: 12.1. Capital (space and equipment) 12.2. Labour (physiotherapy whole time equivalents, employed in the usual and augmented arm physiotherapy) 12.3. Consumables 12.4. Private costs, assessed using a bespoke participant questionnaire 13. Acceptability, assessed through exit interviews with participants in the intervention groups (augmented arm physiotherapy groups) only at the end of the augmented arm physiotherapy intervention 14. Recruitment, retention and adherence rates, assessed by the number of patients approached, deemed eligible and recruited, the number of dropouts (including withdrawals) and the number of therapy sessions taken, recorded from the first approach about the study by clinical staff through to the follow-up (24 weeks) 15. Safety, assessed from the baseline through to the follow-up (24 weeks): 15.1. Participants will | — |
Countries
United Kingdom
Outcome results
None listed