Effectiveness Study of Occupational Therapy in Parkinson's Disease (OTiP)

August 26, 2014 updated by: Radboud University Medical Center

Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Dutch clinical practice guideline for OT in PD (2008)offers a good basis for conducting an intervention study. The completed OTiP pilot underscored the feasibility and the need for a large scale trial.

The OTiP study evaluates the effectiveness of OT in improving daily functioning of patients with PD.

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amersfoort, Netherlands
        • Meander Medisch Centrum
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuizen
      • Blaricum, Netherlands
        • Tergooiziekenhuizen
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Harderwijk, Netherlands
        • St Jansdal
      • Hilversum, Netherlands
        • Tergooiziekenhuizen
      • Utrecht, Netherlands
        • St. Antonius
      • Zeist, Netherlands
        • Diakonessenhuis
      • Zutphen, Netherlands
        • Gelre Ziekenhuizen
      • Zwolle, Netherlands
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria patients:

  • Idiopathic Parkinson's Disease
  • Indication for referral to occupational therapy
  • Home dwelling

Inclusion criteria caregivers

  • Available for informal support minimal two times a week to a patient who participates in the study
  • Available to take part in the intervention

Exclusion Criteria:

  • Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score < 24).
  • Co morbidity 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 (i.e. PARKFIT)
  • Having received occupational therapy intervention in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: occupational therapy
10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease
Behavioral: 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.
No Intervention: No occupational therapy
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: 3 months
Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceive Recall Plan Perform Measure (PRPP)
Time Frame: 3 months
Observational measure. Activity performance patient
3 months
Zarit Burden Inventory (ZBI)
Time Frame: 3 months
Perceived caregiver burden.(caregiver)
3 months
Parkinson's Disease Questionnaire 39 (PDQ-39)
Time Frame: 3 months
Health related Quality of life (Parkinson specific; patient)
3 months
Resource utilization questionnaire
Time Frame: 3 months
For evaluating costs. (patient and caregiver)
3 months
Objective Caregiving Burden
Time Frame: 3 months
Evaluating hours of care (costs). (caregiver)
3 months
Activity Card Sort (ACS)
Time Frame: 3 months
Participation measure:% retained activities.(patient)
3 months
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
Time Frame: 3 months
Satisfaction with participation (patient)
3 months
Becks depression Inventory (BDI)
Time Frame: 3 months
Mood and Depression. (patient)
3 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 months
Mood and depression. (caregiver).
3 months
The Utrecht Proactive Coping Competence list (UPCC)
Time Frame: 3 months
Proactive coping skills. (patient and caregiver)
3 months
Fatigue Severity Scale (FSS)
Time Frame: 3 months
Impact of fatigue (patient)
3 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Time Frame: 3 months
Perceived satisfaction with performance. (patient)
3 months
Quality of life-overall
Time Frame: 3 months
One question on rating overall quality of life (VAS scale). (patient and caregiver).
3 months
Zarit Burden Inventory (ZBI)
Time Frame: 6 months
Perceived caregiver burden. (caregiver)
6 months
Parkinson's Disease Questionnaire 39 (PDQ-39)
Time Frame: 6 months
Health related Quality of life (Parkinson specific)
6 months
Objective Caregiving Burden
Time Frame: 6 months
Evaluating hours of care (costs). (caregiver).
6 months
Euroqol EQ-5D
Time Frame: 6 months
Quality of life. Used for patient and caregiver in evaluation of cost effectiveness
6 months
Canadian Occupational Performance Measure (COPM)
Time Frame: 6 months
Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 months (follow up) wil be used in a secondary analysis and analysis of cost effectiveness.
6 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Time Frame: 6 months
Perceived satisfaction with performance. (patient)
6 months
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)
Time Frame: 6 months
Satisfaction with participation (patient)
6 months
Becks depression Inventory (BDI)
Time Frame: 6 months
Mood and Depression. (patient)
6 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 months
Mood and depression. (caregiver).
6 months
The Utrecht Proactive Coping Competence list (UPCC)
Time Frame: 6 months
Proactive coping skills. (patient and caregiver)
6 months
Fatigue Severity Scale (FSS)
Time Frame: 6 months
Impact of fatigue (patient)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Princess Beatrix Muscle Foundation

Investigators

  • Principal Investigator: Marten Munneke, Phd, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 17, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

August 27, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W.OR09-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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