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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

November 9, 2009
March 17, 2011
October 2009
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01010529 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease
Not Provided

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
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.
  • Experimental: occupational therapy
    Intervention: Other: occupational therapy
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01010529
FNO-0804-66
No
Marten Munneke/Dr, Radboud University Nijmegen Medical Centre
Radboud University
Stichting Nuts Ohra
Principal Investigator: Marten Munneke, Phd UMC St Radboud
Radboud University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP