Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0647150885
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/05/2003
Overall trial end date
01/11/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16 to 20 patients to be recruited during the six months of the study
Participant 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
Recruitment start date
01/05/2003
Recruitment end date
01/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Swindon Intermediate Care Centre
Swindon
SN3 6BW
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Pan-Bath and Swindon Primary Care Research Collaborative (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list