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

NCT ID: NCT01010529

Last Updated: 2011-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-06-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

occupational therapy

Group Type: EXPERIMENTAL

occupational therapy

Intervention Type: OTHER

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.

No occupational therapy

Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

occupational therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• idiopathic Parkinson's Disease according to UK Brain Bank Criteria
• home dwelling
• indication for occupational therapy (according to criteria in the evidence based guideline)

• available to provide informal support minimal two times a week to a patient who participates in the study.

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stichting Nuts Ohra

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Radboud University Nijmegen Medical Centre

Principal Investigators

Marten Munneke, Phd

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Locations

Meander Medisch Centrum, locatie Elisabeth

Amersfoort, , Netherlands

Gelre Ziekenhuizen, locatie Lukas

Apeldoorn, , Netherlands

Alysis Zorggroep, Ziekenhuis Rijnstate

Arnhem, , Netherlands

Ziekenhuis Rivierenland Tiel

Tiel, , Netherlands

Countries

Netherlands

Other Identifiers

FNO-0804-66

Identifier Type: -

Identifier Source: org_study_id