Effectiveness Study of Occupational Therapy in Parkinson's Disease
OTiP
Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial
1 other identifier
interventional
191
1 country
10
Brief Summary
The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 27, 2014
August 1, 2014
1.8 years
March 17, 2011
August 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Canadian Occupational Performance Measure (COPM)
Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)
3 months
Secondary Outcomes (24)
Perceive Recall Plan Perform Measure (PRPP)
3 months
Zarit Burden Inventory (ZBI)
3 months
Parkinson's Disease Questionnaire 39 (PDQ-39)
3 months
Resource utilization questionnaire
3 months
Objective Caregiving Burden
3 months
- +19 more secondary outcomes
Study Arms (2)
occupational therapy
EXPERIMENTAL10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease
No occupational therapy
NO INTERVENTIONPatients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).
Interventions
Patients in the experimental group will receive 10 weeks (maximum 16 hours) occupational therapy according to a treatment protocol, which is based on the Dutch evidence based guideline for occupational therapy in Parkinson's Disease and refined for this study.
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's Disease
- Indication for referral to occupational therapy
- Home dwelling
- Available for informal support minimal two times a week to a patient who participates in the study
- Available to take part in the intervention
You may not qualify if:
- Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems\_MMSE score \< 24).
- Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
- Current participation in other allied health research (i.e. PARKFIT)
- Having received occupational therapy intervention in the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Meander Medisch Centrum
Amersfoort, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Tergooiziekenhuizen
Blaricum, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
St Jansdal
Harderwijk, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
St. Antonius
Utrecht, Netherlands
Diakonessenhuis
Zeist, Netherlands
Gelre Ziekenhuizen
Zutphen, Netherlands
Isala Klinieken
Zwolle, Netherlands
Related Publications (3)
Sturkenboom IH, Hendriks JC, Graff MJ, Adang EM, Munneke M, Nijhuis-van der Sanden MW, Bloem BR. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial. Mov Disord. 2015 Jul;30(8):1059-67. doi: 10.1002/mds.26217. Epub 2015 Apr 8.
PMID: 25854809DERIVEDSturkenboom IH, Graff MJ, Hendriks JC, Veenhuizen Y, Munneke M, Bloem BR, Nijhuis-van der Sanden MW; OTiP study group. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial. Lancet Neurol. 2014 Jun;13(6):557-66. doi: 10.1016/S1474-4422(14)70055-9. Epub 2014 Apr 8.
PMID: 24726066DERIVEDSturkenboom IH, Graff MJ, Borm GF, Adang EM, Nijhuis-van der Sanden MW, Bloem BR, Munneke M. Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2013 Feb 2;14:34. doi: 10.1186/1745-6215-14-34.
PMID: 23374761DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marten Munneke, Phd
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2011
First Posted
April 15, 2011
Study Start
April 1, 2011
Primary Completion
February 1, 2013
Study Completion
June 1, 2013
Last Updated
August 27, 2014
Record last verified: 2014-08