Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility of a RCT evaluating the effectiveness of occupational therapy in Parkinson's disease.

Detailed Description
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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.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: occupational therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: occupational therapy<br> | Other: occupational therapy<br>* 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.<br>|
| No Intervention: No occupational therapy<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient: Combination of AMPS-process skills and COPM-performance measure |  | 0 and 3 months | 
| Caregiver: Zarit Burden Inventory (ZBI) |  | 0 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient: Assessment of Motor and Process Skills(AMPS)- motor skills |  | 0 and 3 months | 
| Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure |  | 0 and 3 months | 
| Patient: Impact on Participation and Autonomy (IPA) |  | 0 and 3 months | 
| Patient: AMC Linear Disability Scale (ALDS) |  | 0 and 3 months | 
| Patient: Parkinson's Disease Questionnaire 39 (PDQ-39) |  | 0 and 3 months | 
| Patient and Caregiver: EQ-5D and VAS |  | 0 and 3 months | 
| Patient and caregiver: Resource utilization |  | 0 and 3 months | 
| Caregiver: Canadian Occupational Performance Measure (COPM) |  | 0 and 3 months | 
| Caregiver: Questionnaire Objective Caregiving Burden |  | 0 and 3 months | 
| Caregiver: SF-36 |  | 0 and 3 months | 
| Patient and caregiver in intervention group: satisfaction with intervention |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational Therapy, Parkinson's Disease, Feasibility, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden