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Clinical Trials/NCT03317353
NCT03317353
Completed
Not Applicable

Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation: Preliminary Study

Hospital Clinico Universitario de Santiago0 sites139 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dizziness Chronic
Sponsor
Hospital Clinico Universitario de Santiago
Enrollment
139
Primary Endpoint
CDP average
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to evaluate the effectiveness of vestibular rehabilitation to improve the balance in older people and reduce the number of falls, comparing three arms with different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group.

Detailed Description

Vestibular rehabilitation has been shown to be effective in compensating patients with residual instability as a result of vestibular system disorders or Parkinson's disease. It is also useful for treating lack of balance in the elderly (presbivertigo). However, there is no systematic, controlled and prospective analysis of whether vestibular rehabilitation is effective in reducing the number of falls in the elderly, or whether its effects in this age group are temporary or persist over time. This study compare vestibular rehabilitation with three different strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group, in people over 65 years. Balance tests are performed before vestibular rehabilitation and three weeks, six months and one year after it. Number of falls are quantified one year after vestibular rehabilitation.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
December 17, 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrés Soto-Varela

Professor and Attending Physician

Hospital Clinico Universitario de Santiago

Eligibility Criteria

Inclusion Criteria

  • Persons with a high risk of falling shall meet at least one of the following requirements:
  • Having fallen at least once in the last 12 months.
  • Using more than 15 seconds or needing support in the TUG test (normal limit calculated in previous studies).
  • Obtaining a mean CDP SOT balance score of \< 68% (normal limit calculated in previous studies).
  • Having fallen at least once in the CDP SOT.

Exclusion Criteria

  • Cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises.
  • Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises.
  • Balance disorders caused by conditions other than age (neurologic, vestibular...).
  • Reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.

Outcomes

Primary Outcomes

CDP average

Time Frame: 12 months

Average score in the Sensory Organization Test of the Computerized Dynamic Posturography

Secondary Outcomes

  • Short FES-I score(12 months)
  • Hospitalisations(12 months)
  • Falls(12 months)
  • Timed-up-and-go steps(12 months)
  • DHI score(12 months)
  • Timed-up-and-go time(12 months)

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