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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: occupational therapy

• Registration Number: NCT01010529
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-10
• Last Update Submitted: 2011-03-17
• Last Update Posted: 2011-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
occupational therapy	occupational therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Meander Medisch Centrum, locatie Elisabeth; 🇳🇱 Amersfoort, Netherlands

Gelre Ziekenhuizen, locatie Lukas; 🇳🇱 Apeldoorn, Netherlands

Ziekenhuis Rivierenland Tiel; 🇳🇱 Tiel, Netherlands

Alysis Zorggroep, Ziekenhuis Rijnstate; 🇳🇱 Arnhem, Netherlands