Clinical trial NCT01010529: Feasibility of a Trial Evaluating the Effectiveness of Occupational Therapy in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Occupational Therapy
Parkinson's Disease
Feasibility
Effectiveness
RCT
Activities of daily living
Participation
Caregiver's Burden
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Nuts Ohra
First posted: 2009-11-10
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient: Combination of AMPS-process skills and COPM-performance measure
timeFrame: 0 and 3 months
measure: Caregiver: Zarit Burden Inventory (ZBI)
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Patient: Assessment of Motor and Process Skills(AMPS)- motor skills
timeFrame: 0 and 3 months
measure: Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure
timeFrame: 0 and 3 months
measure: Patient: Impact on Participation and Autonomy (IPA)
timeFrame: 0 and 3 months
measure: Patient: AMC Linear Disability Scale (ALDS)
timeFrame: 0 and 3 months
measure: Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)
timeFrame: 0 and 3 months
measure: Patient and Caregiver: EQ-5D and VAS
timeFrame: 0 and 3 months
measure: Patient and caregiver: Resource utilization
timeFrame: 0 and 3 months
measure: Caregiver: Canadian Occupational Performance Measure (COPM)
timeFrame: 0 and 3 months
measure: Caregiver: Questionnaire Objective Caregiving Burden
timeFrame: 0 and 3 months
measure: Caregiver: SF-36
timeFrame: 0 and 3 months
measure: Patient and caregiver in intervention group: satisfaction with intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum, locatie Elisabeth
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen, locatie Lukas
city: Arnhem
country: Netherlands
facility: Alysis Zorggroep, Ziekenhuis Rijnstate
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland Tiel
Study officials:
affiliation: UMC St Radboud
name: Marten Munneke, Phd
role: PRINCIPAL_INVESTIGATOR
References: