Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Judith McLain

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes