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Completed

NCT Number: NCT00518648

Reduction of Falls in the Elderly - Parkinson's Disease

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ziekenhuis Groep Twente, Twenteborg Ziekenhuis, Almelo, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multifactorial fall prevention program

Other

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

Usual Care

Other

Usual care

Primary outcomes

  1. Incidence of falls

    Time frame: 8 months

Secondary outcomes

  1. Number of fallers (secondary)

    Time frame: 8 months

  2. Falls Efficacy Scale (tertiary)

    Time frame: 8 months

  3. Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary)

    Time frame: 4 months

  4. Parkinson's Disease quality of life questionnaire (PDQL) (tertiary)

    Time frame: 8 months

  5. Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary)

    Time frame: 8 months

  6. Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary)

    Time frame: 8 months

  7. Number of injurious falls (secondary)

    Time frame: 8 months

  8. Number of patients with injurious falls (secondary)

    Time frame: 8 months

  9. Freezing of gait (tertiary)

    Time frame: 8 months

  10. Costs (secondary)

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • National Parkinson Foundation

Registry information

Acronym: REFINE-PD

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2007
Registry last updated
Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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