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Completed

NCT Number: NCT01010529

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meander Medisch Centrum, locatie Elisabeth, Amersfoort, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational Therapy

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Stichting Nuts Ohra

Registry information

Acronym: OTiP pilot

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2009
Registry last updated
Mar 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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