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

Radboud University Medical Center43 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson's Disease

Interventions

occupational therapyOTHER

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

Sex: ALL

Medical Language ↔ Plain English

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

Locations (4)

Meander Medisch Centrum, locatie Elisabeth

Amersfoort, Netherlands

Gelre Ziekenhuizen, locatie Lukas

Apeldoorn, Netherlands

Alysis Zorggroep, Ziekenhuis Rijnstate

Arnhem, Netherlands

Ziekenhuis Rivierenland Tiel

Tiel, Netherlands

Outcomes

Primary Outcomes

Patient: Combination of AMPS-process skills and COPM-performance measure

Time frame: 0 and 3 months

Caregiver: Zarit Burden Inventory (ZBI)

Time frame: 0 and 3 months

Secondary Outcomes

Patient: Assessment of Motor and Process Skills(AMPS)- motor skills

Time frame: 0 and 3 months

Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure

Time frame: 0 and 3 months

Patient: Impact on Participation and Autonomy (IPA)

Time frame: 0 and 3 months

Patient: AMC Linear Disability Scale (ALDS)

Time frame: 0 and 3 months

Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)

Time frame: 0 and 3 months

Patient and Caregiver: EQ-5D and VAS

Time frame: 0 and 3 months

Patient and caregiver: Resource utilization

Time frame: 0 and 3 months

Caregiver: Canadian Occupational Performance Measure (COPM)

Time frame: 0 and 3 months

Caregiver: Questionnaire Objective Caregiving Burden

Time frame: 0 and 3 months

Data from ClinicalTrials.gov

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