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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedStroke
InterventionA 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 typeOther
Primary outcome measure1. Canadian Occupational Performance Measure (COPM)
2. Motor Assessment Scale (MAS)
3. Barthel Index
4. Patient diary
5. Patient telephone questionnaire
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2003
Completion date01/11/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants16 to 20 patients to be recruited during the six months of the study
Key inclusion criteriaPatients 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 criteria1. 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 enrolment01/05/2003
Date of final enrolment01/11/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Swindon Intermediate Care Centre
Swindon
SN3 6BW
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan