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Clinical Trials/NCT03034655
NCT03034655
Unknown
Not Applicable

Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation (ReFOVeRe Study): Optimizing Costs

Hospital Clinico Universitario de Santiago1 site in 1 country220 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dizziness Chronic
Sponsor
Hospital Clinico Universitario de Santiago
Enrollment
220
Locations
1
Primary Endpoint
CDP Average
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study is to evaluate and compare the effectiveness of vestibular rehabilitation developed using computerized dynamic posturography or a mobile posturographic system with vibrotactile stimulation, to improve the balance in older people and reduce the number of falls.

Detailed Description

Accidental falls, particularly in the elderly, are one of the most important socio-healthcare problems of ageing western societies. Many factors condition and favour falls; one of them is old age, usually related to a decline in sensorial functions and worsening of balance Vestibular rehabilitation has been shown to be effective to improve balance and reduce the number of falls in older people. Previous studies have demonstrated that exercises in computerized dynamic posturography (CDP) are more effective than other vestibular rehabilitation strategies in this group of age. But CDP is very expensive and not widespread. It would be important to minimize cost of posturographic vestibular rehabilitation. This study compare vestibular rehabilitation with two different posturographic devices (CDP and mobile posturographic system with vibrotactile stimulation), in people over 65 years. Additionally, we try to assess whether the reduction in the number of vestibular rehabilitation sessions (five) leads to an improvement in balance and in reducing the number of falls similar to those obtained with ten sessions.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 31, 2018
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 two 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.
  • Obtaining a mean CDP SOT balance score of \< 68%.
  • Having fallen at least once in the CDP SOT.
  • A score in Mobile posturography gSBDT \> 60 %.

Exclusion Criteria

  • Cognitive decline or reduce cultural level that prevents the patient from understanding the assessment, vestibular rehabilitation exercises and granting informed consent.
  • Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of VR exercises.
  • Balance disorders caused by conditions other than age (neurologic, vestibular,....).
  • Current treatment with drugs that potentially disturb balance.

Outcomes

Primary Outcomes

CDP Average

Time Frame: 12 months

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

Secondary Outcomes

  • DHI(12 months)
  • Short FES-I(12 months)
  • Mobile posturografphy gSBDT(12 months)
  • Falls(12 months)
  • TUG(12 months)

Study Sites (1)

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