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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
occupational therapy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Occupational Therapy, Parkinson's Disease, Feasibility, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meander Medisch Centrum, locatie Elisabeth
  • Gelre Ziekenhuizen, locatie Lukas
  • Alysis Zorggroep, Ziekenhuis Rijnstate
  • Ziekenhuis Rivierenland Tiel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

occupational therapy

No occupational therapy

Arm Description

Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months).

Outcomes

Primary Outcome Measures

Patient: Combination of AMPS-process skills and COPM-performance measure
Caregiver: Zarit Burden Inventory (ZBI)

Secondary Outcome Measures

Patient: Assessment of Motor and Process Skills(AMPS)- motor skills
Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure
Patient: Impact on Participation and Autonomy (IPA)
Patient: AMC Linear Disability Scale (ALDS)
Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)
Patient and Caregiver: EQ-5D and VAS
Patient and caregiver: Resource utilization
Caregiver: Canadian Occupational Performance Measure (COPM)
Caregiver: Questionnaire Objective Caregiving Burden
Caregiver: SF-36
Patient and caregiver in intervention group: satisfaction with intervention

Full Information

First Posted
November 9, 2009
Last Updated
March 17, 2011
Sponsor
Radboud University Medical Center
Collaborators
Stichting Nuts Ohra
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1. Study Identification

Unique Protocol Identification Number
NCT01010529
Brief Title
Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease
Acronym
OTiP pilot
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Stichting Nuts Ohra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Occupational Therapy, Parkinson's Disease, Feasibility, Effectiveness, RCT, Activities of daily living, Participation, Caregiver's Burden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
occupational therapy
Arm Type
Experimental
Arm Title
No occupational therapy
Arm Type
No Intervention
Arm Description
Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (3 months).
Intervention Type
Other
Intervention Name(s)
occupational therapy
Intervention Description
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 Outcome Measure Information:
Title
Patient: Combination of AMPS-process skills and COPM-performance measure
Time Frame
0 and 3 months
Title
Caregiver: Zarit Burden Inventory (ZBI)
Time Frame
0 and 3 months
Secondary Outcome Measure Information:
Title
Patient: Assessment of Motor and Process Skills(AMPS)- motor skills
Time Frame
0 and 3 months
Title
Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure
Time Frame
0 and 3 months
Title
Patient: Impact on Participation and Autonomy (IPA)
Time Frame
0 and 3 months
Title
Patient: AMC Linear Disability Scale (ALDS)
Time Frame
0 and 3 months
Title
Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)
Time Frame
0 and 3 months
Title
Patient and Caregiver: EQ-5D and VAS
Time Frame
0 and 3 months
Title
Patient and caregiver: Resource utilization
Time Frame
0 and 3 months
Title
Caregiver: Canadian Occupational Performance Measure (COPM)
Time Frame
0 and 3 months
Title
Caregiver: Questionnaire Objective Caregiving Burden
Time Frame
0 and 3 months
Title
Caregiver: SF-36
Time Frame
0 and 3 months
Title
Patient and caregiver in intervention group: satisfaction with intervention
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, Phd
Organizational Affiliation
UMC St Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meander Medisch Centrum, locatie Elisabeth
City
Amersfoort
ZIP/Postal Code
3816CP
Country
Netherlands
Facility Name
Gelre Ziekenhuizen, locatie Lukas
City
Apeldoorn
ZIP/Postal Code
7300DS
Country
Netherlands
Facility Name
Alysis Zorggroep, Ziekenhuis Rijnstate
City
Arnhem
ZIP/Postal Code
6800TA
Country
Netherlands
Facility Name
Ziekenhuis Rivierenland Tiel
City
Tiel
ZIP/Postal Code
4000HA
Country
Netherlands

12. IPD Sharing Statement

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

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