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Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease (OTiP pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010529
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : March 18, 2011
Stichting Nuts Ohra
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: occupational therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: occupational therapy Other: 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 (3 months).

Primary Outcome Measures :
  1. Patient: Combination of AMPS-process skills and COPM-performance measure [ Time Frame: 0 and 3 months ]
  2. Caregiver: Zarit Burden Inventory (ZBI) [ Time Frame: 0 and 3 months ]

Secondary Outcome Measures :
  1. Patient: Assessment of Motor and Process Skills(AMPS)- motor skills [ Time Frame: 0 and 3 months ]
  2. Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure [ Time Frame: 0 and 3 months ]
  3. Patient: Impact on Participation and Autonomy (IPA) [ Time Frame: 0 and 3 months ]
  4. Patient: AMC Linear Disability Scale (ALDS) [ Time Frame: 0 and 3 months ]
  5. Patient: Parkinson's Disease Questionnaire 39 (PDQ-39) [ Time Frame: 0 and 3 months ]
  6. Patient and Caregiver: EQ-5D and VAS [ Time Frame: 0 and 3 months ]
  7. Patient and caregiver: Resource utilization [ Time Frame: 0 and 3 months ]
  8. Caregiver: Canadian Occupational Performance Measure (COPM) [ Time Frame: 0 and 3 months ]
  9. Caregiver: Questionnaire Objective Caregiving Burden [ Time Frame: 0 and 3 months ]
  10. Caregiver: SF-36 [ Time Frame: 0 and 3 months ]
  11. Patient and caregiver in intervention group: satisfaction with intervention [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria patients:

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

Inclusion criteria caregivers:

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

Exclusion criteria patients:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010529

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Meander Medisch Centrum, locatie Elisabeth
Amersfoort, Netherlands, 3816CP
Gelre Ziekenhuizen, locatie Lukas
Apeldoorn, Netherlands, 7300DS
Alysis Zorggroep, Ziekenhuis Rijnstate
Arnhem, Netherlands, 6800TA
Ziekenhuis Rivierenland Tiel
Tiel, Netherlands, 4000HA
Sponsors and Collaborators
Radboud University
Stichting Nuts Ohra
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Principal Investigator: Marten Munneke, Phd UMC St Radboud

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Responsible Party: Marten Munneke/Dr, Radboud University Nijmegen Medical Centre Identifier: NCT01010529     History of Changes
Other Study ID Numbers: FNO-0804-66
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: October 2010
Keywords provided by Radboud University:
Occupational Therapy
Parkinson's Disease
Activities of daily living
Caregiver's Burden
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases