Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomised trial

ISRCTN ISRCTN85468190
DOI https://doi.org/10.1186/ISRCTN85468190
Secondary identifying numbers NL830, NTR843
Submission date
16/01/2007
Registration date
16/01/2007
Last edited
14/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Isaline CJM Eyssen
Scientific

VU University Medical Center
Department of Rehabilitation Medicine, Occupational and Physical Therapy
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 444 0012
Email i.eyssen@vumc.nl

Study information

Study designRandomised, controlled, parallel group, double blinded, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEfficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomised trial
Study acronymMUSCOT
Study objectivesClient-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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedMultiple sclerosis (MS)
InterventionExperimental intervention: client-centred occupational therapy accoridng to the Occupational Performance Process Model (OPPM).

Control intervention: usual-care occupational therapy.
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/01/2007
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants280
Total final enrolment269
Key inclusion criteria1. Diagnosed Multiple Sclerosis
2. New referral for occupational therapy
3. Age between 18 and 75 years
Key exclusion criteria1. Major depression
Date of first enrolment01/01/2007
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center (The Netherlands)
Hospital/treatment centre

Department of Rehabilitation Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Website http://www.vumc.nl/english/
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

Stichting MS Research (The Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Dutch Multiple Sclerosis Research Foundation
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2013 14/01/2021 Yes No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.