Effectiveness Study of Occupational Therapy in Parkinson's Disease (OTiP)

Radboud University Medical Center

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01336127

W.OR09-29

Details and patient eligibility

About

The purpose of this study is to determine 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 Dutch clinical practice guideline for OT in PD (2008)offers a good basis for conducting an intervention study. The completed OTiP pilot underscored the feasibility and the need for a large scale trial.

The OTiP study evaluates the effectiveness of OT in improving daily functioning of patients with PD.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria patients:

• Idiopathic Parkinson's Disease
• Indication for referral to occupational therapy
• Home dwelling

Inclusion criteria caregivers

• Available for informal support minimal two times a week to a patient who participates in the study
• Available to take part in the intervention

Exclusion Criteria:

• Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score < 24).
• Co morbidity 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 (i.e. PARKFIT)
• Having received occupational therapy intervention in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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191 participants in 2 patient groups

occupational therapy

Experimental group

Description:

10 weeks occupational therapy according to a protocol (OTiP protocol) based on the Dutch guidelines of occupational therapy in Parkinson's disease

Treatment:

Behavioral: 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 (6 months).