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Open Access Highly Accessed Study protocol

Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial

Ingrid HWM Sturkenboom1*, Maud J Graff12, George F Borm3, Eddy MM Adang3, Maria WG Nijhuis-van der Sanden12, Bastiaan R Bloem4 and Marten Munneke5

Author Affiliations

1 Nijmegen Centre of Evidence Based Practice, Department of Rehabilitation-Occupational Therapy (898), Radboud University Nijmegen Medical Centre, Reinier Postlaan 2, 6525GC, PO Box 9101, 6500HB, Nijmegen, The Netherlands

2 Nijmegen Centre of Evidence Based Practice, Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

3 Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

4 Donders Institute for Brain, Cognition and Behavior; Department of Neurology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

5 Nijmegen Centre of Evidence Based Practice, Department of Neurology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

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Trials 2013, 14:34  doi:10.1186/1745-6215-14-34

Published: 2 February 2013

Abstract

Background

Occupational therapists may have an added value in the care of patients with Parkinson’s disease whose daily functioning is compromised, as well as for their immediate caregivers. Evidence for this added value is inconclusive due to a lack of rigorous studies. The aim of this trial is to evaluate the (cost) effectiveness of occupational therapy in improving daily functioning of patients with Parkinson’s disease.

Methods/Design

A multicenter, assessor-blinded, two-armed randomized controlled clinical trial will be conducted, with evaluations at three and six months. One hundred ninety-two home-dwelling patients with Parkinson’s disease and with an occupational therapy indication will be assigned to the experimental group or to the control group (2:1). Patients and their caregivers in the experimental group will receive ten weeks of home-based occupational therapy according to recent Dutch guidelines. The intervention will be delivered by occupational therapists who have been specifically trained to treat patients according to these guidelines. Participants in the control group will not receive occupational therapy during the study period. The primary outcome for the patient is self-perceived daily functioning at three months, assessed with the Canadian Occupational Performance Measure. Secondary patient-related outcomes include: objective performance of daily activities, self-perceived satisfaction with performance in daily activities, participation, impact of fatigue, proactive coping skills, health-related quality of life, overall quality of life, health-related costs, and effectiveness at six months. All outcomes at the caregiver level will be secondary and will include self-perceived burden of care, objective burden of care, proactive coping skills, overall quality of life, and care-related costs. Effectiveness will be evaluated using a covariance analysis of the difference in outcome at three months. An economic evaluation from a societal perspective will be conducted, as well as a process evaluation.

Discussion

This is the first large-scale trial specifically evaluating occupational therapy in Parkinson’s disease. It is expected to generate important new information about the possible added value of occupational therapy on daily functioning of patients with Parkinson’s disease.

Trial registration

Clinicaltrials.gov: NCT01336127.

Keywords:
Parkinson disease; Occupational therapy; Guidelines; caregiver; Randomized controlled trial; Study protocol; Effectiveness; Economic evaluation