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Clinical Trials/NCT01010529
NCT01010529
Completed
N/A

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

Radboud University Medical Center4 sites in 1 country43 target enrollmentOctober 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Radboud University Medical Center
Enrollment
43
Locations
4
Primary Endpoint
Patient: Combination of AMPS-process skills and COPM-performance measure
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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(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)

Study Sites (4)

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