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
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
-
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.