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Completed

NCT Number: NCT03317353

Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation: Preliminary Study

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Vestibular rehabil.: CDP

Device

Vestibular rehabilitation, ten sessions

Other names: Computerized Dynamic Posturography

Vestibular rehabil.: optokinetic stimuli

Device

Vestibular rehabilitation, ten sessions

Vestibular rehabil.: home exercises

Other

Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes

Primary outcomes

  1. CDP average

    Time frame: 12 months

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

Secondary outcomes

  1. Falls

    Time frame: 12 months

    Number of falls after vestibular rehabilitation

  2. Hospitalisations

    Time frame: 12 months

    Hospitalisations due to falls in previous 12 months

  3. DHI score

    Time frame: 12 months

    Dizziness Handicap Inventory score; it assesses the disability perceived by the patient in relation to instability. Minimum: 0; maximum: 100.

  4. Short FES-I score

    Time frame: 12 months

    A shortened version of the falls efficacy scale-international to assess fear of falling score. Minimum: 0; maximum: 21.

  5. Timed-up-and-go time

    Time frame: 12 months

    Duration (in seconds) of modified Timed-up-and-go test

  6. Timed-up-and-go steps

    Time frame: 12 months

    Steps to perform the modified Timed-up-and-go test

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Collaborators

  • European Regional Development Fund
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: ReFOVeRe

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 23, 2017
Registry last updated
Oct 24, 2017

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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