An investigation into the effect of including a goal-orientated independently practised exercise programme in early stroke rehabilitation
ISRCTN | ISRCTN49538372 |
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DOI | https://doi.org/10.1186/ISRCTN49538372 |
Secondary identifying numbers | N0647150885 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 07/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Judith McLain
Scientific
Scientific
Swindon Intermediate Care Centre
Downs Way
Swindon
SN3 6BW
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To evaluate the effects of goal-orientated individualised exercise and activity programmes practised independently in the first three months of stroke in addition to normal therapy, both from the perspective of the patient and the clinician's evaluation of the patient's performance. To pilot the intervention to establish evidence for or against the feasibility of including independently practised goal-orientated exercise programmes in early stroke rehabilitation. The results of the study, if positive, will inform a power calculation and design of a full randomised controlled trial. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Stroke |
Intervention | A single-blinded RCT pilot using blocked randomisation in blocks of 4. Goal-orientated individualised exercise and activity programmes practised independently in the first three months of stroke in addition to normal therapy. |
Intervention type | Other |
Primary outcome measure | 1. Canadian Occupational Performance Measure (COPM) 2. Motor Assessment Scale (MAS) 3. Barthel Index 4. Patient diary 5. Patient telephone questionnaire |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/05/2003 |
Completion date | 01/11/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 16 to 20 patients to be recruited during the six months of the study |
Key inclusion criteria | Patients admitted to the stroke ward and medically able to understand and comply with the protocol. Inclusion criteria: 1. Inpatients within 6 weeks of diagnosis fo first stroke confirmed by computed tomography (CT) scan 2. Medically stable and undergoing rehabilitation on a stroke and neurological unit 3. In the opinion of the researchers, have the ability to understand and comply with carrying out an exercise and activity programme on their own 4. Patients must be able to give informed consent |
Key exclusion criteria | 1. Complex medical problems that prevent compliance with study protocol 2. The patient is likely to be discharged within two weeks of admission to the stroke and neurological unit |
Date of first enrolment | 01/05/2003 |
Date of final enrolment | 01/11/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Swindon Intermediate Care Centre
Swindon
SN3 6BW
United Kingdom
SN3 6BW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Pan-Bath and Swindon Primary Care Research Collaborative (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |