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

Parkinson's Disease Clinical Trial

— OTiP pilot  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010529
• Other study ID #: FNO-0804-66
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: March 17, 2011
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Meander Medisch Centrum, locatie Elisabeth	Amersfoort
Netherlands	Gelre Ziekenhuizen, locatie Lukas	Apeldoorn
Netherlands	Alysis Zorggroep, Ziekenhuis Rijnstate	Arnhem
Netherlands	Ziekenhuis Rivierenland Tiel	Tiel

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Stichting Nuts Ohra

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient: Combination of AMPS-process skills and COPM-performance measure		0 and 3 months	Yes
Primary	Caregiver: Zarit Burden Inventory (ZBI)		0 and 3 months	No
Secondary	Patient: Assessment of Motor and Process Skills(AMPS)- motor skills		0 and 3 months	Yes
Secondary	Patient: Canadian Occupational Performance Measure (COPM)- satisfaction measure		0 and 3 months	No
Secondary	Patient: Impact on Participation and Autonomy (IPA)		0 and 3 months	No
Secondary	Patient: AMC Linear Disability Scale (ALDS)		0 and 3 months	No
Secondary	Patient: Parkinson's Disease Questionnaire 39 (PDQ-39)		0 and 3 months	No
Secondary	Patient and Caregiver: EQ-5D and VAS		0 and 3 months	No
Secondary	Patient and caregiver: Resource utilization		0 and 3 months	No
Secondary	Caregiver: Canadian Occupational Performance Measure (COPM)		0 and 3 months	No
Secondary	Caregiver: Questionnaire Objective Caregiving Burden		0 and 3 months	No
Secondary	Caregiver: SF-36		0 and 3 months	No
Secondary	Patient and caregiver in intervention group: satisfaction with intervention		3 months	No