Effectiveness Study of Occupational Therapy in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Occupational Therapy

• Registration Number: NCT01336127
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of this study is to determine 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 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.

Study Timeline

• Study First Submitted: 2011-03-17
• Study Start: 2011-04
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Primary Completion: 2013-02
• Study Completion: 2013-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	3 months	Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 months (see secondary outcome measures)

Secondary Outcome Measures

Name	Time	Method
Parkinson's Disease Questionnaire 39 (PDQ-39)	6 months	Health related Quality of life (Parkinson specific)
Hospital Anxiety and Depression Scale (HADS)	6 months	Mood and depression. (caregiver).
Perceive Recall Plan Perform Measure (PRPP)	3 months	Observational measure. Activity performance patient
Resource utilization questionnaire	3 months	For evaluating costs. (patient and caregiver)
Becks depression Inventory (BDI)	6 months	Mood and Depression. (patient)
The Utrecht Proactive Coping Competence list (UPCC)	6 months	Proactive coping skills. (patient and caregiver)
Fatigue Severity Scale (FSS)	6 months	Impact of fatigue (patient)
Euroqol EQ-5D	6 months	Quality of life. Used for patient and caregiver in evaluation of cost effectiveness
Zarit Burden Inventory (ZBI)	6 months	Perceived caregiver burden. (caregiver)
Objective Caregiving Burden	6 months	Evaluating hours of care (costs). (caregiver).
Canadian Occupational Performance Measure (COPM)	6 months	Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 months (follow up) wil be used in a secondary analysis and analysis of cost effectiveness.
Activity Card Sort (ACS)	3 months	Participation measure:% retained activities.(patient)
The Utrecht Scale for evaluation of Rehabilitation Participation (USER-P)(section III)	6 months	Satisfaction with participation (patient)
Canadian Occupational Performance Measure (COPM-satisfaction)	6 months	Perceived satisfaction with performance. (patient)
Quality of life-overall	3 months	One question on rating overall quality of life (VAS scale). (patient and caregiver).

Trial Locations

Locations (8)

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands

Gelre Ziekenhuizen; 🇳🇱 Zutphen, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

St. Antonius; 🇳🇱 Utrecht, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Diakonessenhuis; 🇳🇱 Zeist, Netherlands

Tergooiziekenhuizen; 🇳🇱 Hilversum, Netherlands

St Jansdal; 🇳🇱 Harderwijk, Netherlands