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Reduction of Falls in the Elderly - Parkinson's Disease

NCT ID: NCT00518648

Last Updated: 2010-11-23

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

PHASE3

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

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The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls prevention program for patients with Parkinson's Disease (PD). This program contains PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention program. The intervention will be tailored to each individual's specific risk profile for falls, as identified during detailed baseline examination.

Detailed Description

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Falls and postural instability are common complications of advanced Parkinson's Disease (PD). Falls in PD often have devastating consequences, leading to a poor overall prognosis. In addition, falls in PD are associated with substantial medical expenses due to treatment of injuries and nursing home admission. The risk of falls in older PD patients is aggravated by "generic" age-related factors, such as sedative medication or poor vision. Observations on elderly persons without PD suggest that a multifactorial prevention program might be more effective. We propose to investigate the effectiveness of a multifactorial prevention program aimed at the prevention of falls in PD, which is based on disease-specific treatment strategies with demonstrated efficacy in PD, as well as prevention strategies with proven effectiveness for the general elderly population.

In this study an individualised multifactorial program aimed at the prevention of falls in PD containing PD-specific elements and a generic falls prevention program will be compared to usual care.

Conditions

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Parkinson's Disease

Keywords

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Accidental falls Prevention Treatment effectiveness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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I

Multifactorial fall prevention program

Group Type EXPERIMENTAL

Multifactorial fall prevention program

Intervention Type OTHER

Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements

II

Usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Usual care

Interventions

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Multifactorial fall prevention program

Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements

Intervention Type OTHER

Usual care

Usual care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with idiopathic Parkinson's Disease, diagnosed according to the Brain Bank criteria of the UK Parkinson's Society
* Regular control by the neurologist
* Living independently in the community
* Able to complete the trial questionnaires
* An increased risk for falling, defined as:

* at least one fall in the preceding 12 months OR
* recurrent (monthly) near falls in the preceding 12 months OR
* fear of falling OR (iv) avoidance of activities due to fear of falling OR a combination of these findings

Exclusion Criteria

* Atypical parkinsonian syndromes
* Hoehn and Yahr stage 5
* Severe cognitive impairment (MMSE \< 24)
* Severe co-morbidity (e.g., cancer)
* Planned surgical procedure for PD within the intervention period
* Patients who have already visited the Multidisciplinary Assessment Center
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Parkinson Foundation

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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UMC St Radboud, Neurology

Principal Investigators

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Marten Munneke, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St. Radboud

Bastiaan R. Bloem, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St. Radboud

Marjolein A. van der Marck, MSc

Role: PRINCIPAL_INVESTIGATOR

UMC St. Radboud

Locations

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Ziekenhuis Groep Twente, Twenteborg Ziekenhuis

Almelo, , Netherlands

Site Status

Ziekenhuis Rijnstate

Arnhem, , Netherlands

Site Status

Wilhelmina Ziekenhuis Assen

Assen, , Netherlands

Site Status

Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente

Hengelo, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2007_RP1.1

Identifier Type: -

Identifier Source: org_study_id