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

ISRCTN	ISRCTN85468190
DOI	https://doi.org/10.1186/ISRCTN85468190
Protocol serial number	NL830, NTR843
Sponsor	VU University Medical Center (The Netherlands)
Funder	Stichting MS Research (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, double blinded, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomised trial
Study acronym	MUSCOT
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Disability Impact Profile (DIP) questionnaire 2. Impact on Participation and Autonomy (IPA) questionnaire At baseline) and after four and eight months follow-up.
Key secondary outcome measure(s)	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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	280
Total final enrolment	269
Key inclusion criteria	1. Diagnosed Multiple Sclerosis 2. New referral for occupational therapy 3. Age between 18 and 75 years
Key exclusion criteria	1. Major depression
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1007 MB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/09/2013	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.