Condition category
Nervous System Diseases
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
16/01/2007
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

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

http://www.vumc.nl/english/

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

Publication citations

Additional files

Editorial Notes