- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010529
Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease (OTiP pilot)
March 17, 2011 updated by: Radboud University Medical Center
The purpose of this study is to determine the feasibility of a RCT evaluating the effectiveness of occupational therapy in Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients.
Occupational Therapy aims to optimise functional performance and engagement in meaningful roles and activities.
The lack of scientific evidence for the effectiveness of Occupational Therapy (OT) in Parkinson's Disease (PD) highlights the urgent need for high quality intervention studies.
The recently developed Dutch clinical practice guideline for OT in PD offers a good basis for conducting an intervention study.
This proposed pilot study is an important step towards setting up a large scale RCT to evaluate the effectiveness of OT in improving daily functioning of patients with PD and reducing caregivers' burden.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amersfoort, Netherlands, 3816CP
- Meander Medisch Centrum, locatie Elisabeth
-
Apeldoorn, Netherlands, 7300DS
- Gelre ziekenhuizen, locatie Lukas
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Arnhem, Netherlands, 6800TA
- Alysis Zorggroep, Ziekenhuis Rijnstate
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Tiel, Netherlands, 4000HA
- Ziekenhuis Rivierenland Tiel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria patients:
- idiopathic Parkinson's Disease according to UK Brain Bank Criteria
- home dwelling
- indication for occupational therapy (according to criteria in the evidence based guideline)
Inclusion criteria caregivers:
- available to provide informal support minimal two times a week to a patient who participates in the study.
Exclusion criteria patients:
- not capable of completing the self assessment forms (i.e. due to language or severe cognitive problems)
- comorbidity 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 (IMPACT, PARKFIT, ERGODIM)
- having received occupational therapy intervention in the last 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: occupational therapy
|
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.
|
No Intervention: No occupational therapy
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient: Combination of AMPS-process skills and COPM-performance measure
Time Frame: 0 and 3 months
|
0 and 3 months
|
Caregiver: Zarit Burden Inventory (ZBI)
Time Frame: 0 and 3 months
|
0 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient: Assessment of Motor and Process Skills(AMPS)- motor skills
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient: Impact on Participation and Autonomy (IPA)
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient: AMC Linear Disability Scale (ALDS)
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient and Caregiver: EQ-5D and VAS
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient and caregiver: Resource utilization
Time Frame: 0 and 3 months
|
0 and 3 months
|
Caregiver: Canadian Occupational Performance Measure (COPM)
Time Frame: 0 and 3 months
|
0 and 3 months
|
Caregiver: Questionnaire Objective Caregiving Burden
Time Frame: 0 and 3 months
|
0 and 3 months
|
Caregiver: SF-36
Time Frame: 0 and 3 months
|
0 and 3 months
|
Patient and caregiver in intervention group: satisfaction with intervention
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marten Munneke, PhD, UMC St Radboud
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
March 18, 2011
Last Update Submitted That Met QC Criteria
March 17, 2011
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FNO-0804-66
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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