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

This study has been completed.
Sponsor:
Collaborator:
Stichting Nuts Ohra
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01010529
First received: November 9, 2009
Last updated: March 17, 2011
Last verified: October 2010
  Purpose

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


Condition Intervention
Parkinson's Disease
Other: occupational therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Patient: Combination of AMPS-process skills and COPM-performance measure [ Time Frame: 0 and 3 months ] [ Designated as safety issue: Yes ]
  • Caregiver: Zarit Burden Inventory (ZBI) [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient: Assessment of Motor and Process Skills(AMPS)- motor skills [ Time Frame: 0 and 3 months ] [ Designated as safety issue: Yes ]
  • Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Patient: Impact on Participation and Autonomy (IPA) [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Patient: AMC Linear Disability Scale (ALDS) [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Patient: Parkinson's Disease Questionnaire 39 (PDQ-39) [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Patient and Caregiver: EQ-5D and VAS [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Patient and caregiver: Resource utilization [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Caregiver: Canadian Occupational Performance Measure (COPM) [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Caregiver: Questionnaire Objective Caregiving Burden [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Caregiver: SF-36 [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
  • Patient and caregiver in intervention group: satisfaction with intervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010529

Locations
Netherlands
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
Investigators
Principal Investigator: Marten Munneke, Phd UMC St Radboud
  More Information

No publications provided

Responsible Party: Marten Munneke/Dr, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT01010529     History of Changes
Other Study ID Numbers: FNO-0804-66
Study First Received: November 9, 2009
Last Updated: March 17, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Occupational Therapy
Parkinson's Disease
Feasibility
Effectiveness
RCT
Activities of daily living
Participation
Caregiver's Burden

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 15, 2014