Effectiveness Study of Occupational Therapy in Parkinson's Disease

NCT ID: NCT01336127

Last Updated: 2014-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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occupational therapy

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

Group Type EXPERIMENTAL

Occupational Therapy

Intervention Type BEHAVIORAL

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.

No occupational therapy

Patients and their caregivers in the control group will have no occupational therapy intervention until their last measurement has taken place (6 months).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Beatrix Muscle Foundation

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marten Munneke, Phd

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

Gelre Ziekenhuizen

Apeldoorn, , Netherlands

Site Status

Tergooiziekenhuizen

Blaricum, , Netherlands

Site Status

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status

St Jansdal

Harderwijk, , Netherlands

Site Status

Tergooiziekenhuizen

Hilversum, , Netherlands

Site Status

St. Antonius

Utrecht, , Netherlands

Site Status

Diakonessenhuis

Zeist, , Netherlands

Site Status

Gelre Ziekenhuizen

Zutphen, , Netherlands

Site Status

Isala Klinieken

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

References

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Sturkenboom IH, Hendriks JC, Graff MJ, Adang EM, Munneke M, Nijhuis-van der Sanden MW, Bloem BR. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial. Mov Disord. 2015 Jul;30(8):1059-67. doi: 10.1002/mds.26217. Epub 2015 Apr 8.

Reference Type DERIVED
PMID: 25854809 (View on PubMed)

Sturkenboom IH, Graff MJ, Hendriks JC, Veenhuizen Y, Munneke M, Bloem BR, Nijhuis-van der Sanden MW; OTiP study group. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial. Lancet Neurol. 2014 Jun;13(6):557-66. doi: 10.1016/S1474-4422(14)70055-9. Epub 2014 Apr 8.

Reference Type DERIVED
PMID: 24726066 (View on PubMed)

Sturkenboom IH, Graff MJ, Borm GF, Adang EM, Nijhuis-van der Sanden MW, Bloem BR, Munneke M. Effectiveness of occupational therapy in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2013 Feb 2;14:34. doi: 10.1186/1745-6215-14-34.

Reference Type DERIVED
PMID: 23374761 (View on PubMed)

Other Identifiers

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W.OR09-29

Identifier Type: -

Identifier Source: org_study_id

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