An investigation into the effect of including a goal-orientated independently practised exercise programme in early stroke rehabilitation

ISRCTN	ISRCTN49538372
DOI	https://doi.org/10.1186/ISRCTN49538372
Protocol serial number	N0647150885
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Funders	Pan-Bath and Swindon Primary Care Research Collaborative (UK), NHS R&D Support Funding (UK)

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

Ms Judith McLain
Scientific

Swindon Intermediate Care Centre
Downs Way
Swindon
SN3 6BW
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Canadian Occupational Performance Measure (COPM) 2. Motor Assessment Scale (MAS) 3. Barthel Index 4. Patient diary 5. Patient telephone questionnaire
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/11/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
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

Swindon Intermediate Care Centre

Swindon
SN3 6BW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan