Multi-centre trial of out patient occupational therapy for stroke

ISRCTN	ISRCTN40732755
DOI	https://doi.org/10.1186/ISRCTN40732755
Secondary identifying numbers	MS138

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 20/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Gladman
Scientific

Ageing and Disability Research Unit
Division of Rehabilitation and Ageing
School of Community Health Sciences
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 924 9924 x 42618
Email	john.gladman@nottingham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To evaluate the effects of leisure therapy and conventional occupational therapy (OT) on the mood, leisure participation and independence in Activities of Daily Living (ADL) of stroke patients six months and twelve months after hospital discharge.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cerebrovascular disease and stroke
Intervention	Community occupational therapy aimed at promoting independence in activities of daily living (ADL) was compared to occupational therapy aiming to promote leisure activity, or no trial intervention. Maximum of 10 visits over six months in treated patients.
Intervention type	Other
Primary outcome measure	1. Personal ADL (Barthel ADL Index) 2. Instrumental ADL (Nottingham Extended ADL scale) 3. Mood (GHQ-12) 4. Leisure activity (abbreviated Nottingham Leisure Questionnaire) 5. Handicap (London Handicap Scale) 6. Global outcome (Oxford Handicap Score, and International Stroke Trial Questions)
Secondary outcome measures	Not provided at time of registration
Overall study start date	31/01/1997
Completion date	31/01/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	209 (Added 19/11/09)
Key inclusion criteria	In 4/5 centres, patients with stroke were recruited at discharge from hospital. In the other centre patients were seen in an out-patient clinic.
Key exclusion criteria	Those discharged to institutional care were excluded.
Date of first enrolment	31/01/1997
Date of final enrolment	31/01/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Ageing and Disability Research Unit

Nottingham
NG7 2UH
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

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

Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2001		Yes	No