Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
20/11/2009
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

Dr John Gladman

ORCID ID

Contact details

Ageing and Disability Research Unit
Division of Rehabilitation and Ageing
School of Community Health Sciences
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 x 42618
john.gladman@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MS138

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

31/01/1997

Overall trial end date

31/01/2000

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

209 (Added 19/11/09)

Participant exclusion criteria

Those discharged to institutional care were excluded.

Recruitment start date

31/01/1997

Recruitment end date

31/01/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ageing and Disability Research Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme (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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11237160

Publication citations

  1. Results

    Parker CJ, Gladman JR, Drummond AE, Dewey ME, Lincoln NB, Barer D, Logan PA, Radford KA, A multicentre randomized controlled trial of leisure therapy and conventional occupational therapy after stroke. TOTAL Study Group. Trial of Occupational Therapy and Leisure., Clin Rehabil, 2001, 15, 1, 42-52.

Additional files

Editorial Notes