Contact information
Type
Scientific
Primary contact
Ms Isaline CJM Eyssen
ORCID ID
Contact details
VU University Medical Center
Department of Rehabilitation Medicine
Occupational and Physical Therapy
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 0012
i.eyssen@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MUSCOT
Study hypothesis
Client-centred occupational therapy according to the Occupational Performance Process Model will be more effective in improving daily functioning and societal participation of patients with multiple sclerosis than usual-care occupational therapy.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, controlled, parallel group, double blinded, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Multiple sclerosis (MS)
Intervention
Experimental intervention: client-centred occupational therapy accoridng to the Occupational Performance Process Model (OPPM).
Control intervention: usual-care occupational therapy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Disability Impact Profile (DIP) questionnaire
2. Impact on Participation and Autonomy (IPA) questionnaire
At baseline) and after four and eight months follow-up.
Secondary outcome measures
1. Evaluation of Client-Centred Process (ECGP) questionnaire
2. Quality of Care through the patient's eyes (QUOTE-EEE) questionnaire
3. Canadian Occupational Performance Measure (COPM)
4. Nine-Hole Peg Test (9-HPT) Dexterity measure
5. Fatigue (Modified Fatigue Impact Scale [MFIS]) questionnaire
6. Pain (Pain Effects Scale [PES]) questionnaire
7. Cognitive functioning (Perceived Deficits Questionnaire [PDQ]) questionnaire
8. Generic Health-related Quality of Life (Short Form health survey [SF-36]) questionnaire
At baseline, and after four and eight months follow-up.
Overall trial start date
01/01/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosed Multiple Sclerosis
2. New referral for occupational therapy
3. Age between 18 and 75 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
280
Participant exclusion criteria
1. Major depression
Recruitment start date
01/01/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Center (The Netherlands)
Sponsor details
Department of Rehabilitation Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Stichting MS Research (The Netherlands)
Alternative name(s)
Dutch Multiple Sclerosis Research Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
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