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
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 |
|---|---|
| i.eyssen@vumc.nl |
Study information
| Study design | Randomised, controlled, parallel group, double blinded, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
1007 MB
Netherlands
Sponsor information
VU University Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Rehabilitation Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
