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

Radboud University Medical Center

Status: Completed

Conditions: Parkinson's Disease

Treatments: Other: occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01010529

FNO-0804-66

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

occupational therapy

Experimental group

Treatment:

Other: occupational therapy

No occupational therapy

No Intervention group

Description:

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