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

October 20, 2017 updated by: Andrés Soto-Varela, Hospital Clinico Universitario de Santiago

Reducing Rate of Falls in Older People With the Improvement of Balance 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vestibular rehabil.: CDP
Group A. The Smart Equitest program was used with a protocol of 10 exercises per session, which were customized depending on each patient´s deficit. The exercises involve visual biofeedback together with sensitive, real-time monitoring of movement. In some exercises, patients must maintain their center of gravity (COG) over the base of support, while in others the COG must be moved to a series of targets. In addition, the support surface and/or visual surround may also move in response to the patient´s own movement. The exercise difficulty was progressively increased throughout the rehabilitation sessions. The duration of each session was approximately 15 minutes. The distribution of sessions was one per day and five per week (2 weeks).
Device: Vestibular rehabil.: CDP
Vestibular rehabilitation, ten sessions
Other Names:
  • Computerized Dynamic Posturography
Experimental: Vestibular rehabil.: optokinetic stimuli
Group B. Patient has to stand in a dark room, wiht optokinetic stimuli around him/her. Ten sessions (one per day, five per week, two weeks), with progressive increase of stimulus speed (from 30º/sec the first day to 100º/sec the last), duration of session (from 5 minutes the first day to 15 minutes the last), stimulus complexity (horizontal stimuli in the first sessions, progressively adding vertical and rotating stimuli) and support surface difficulty (initially hard surface, last sessions on foam).
Device: Vestibular rehabil.: optokinetic stimuli
Vestibular rehabilitation, ten sessions
Experimental: Vestibular rehabil.: home exercises
Group C. The patient is given a list of exercises (and explained how to do them) to stabilise eye position and improve postural control. They are to be performed twice a day for two weeks. Approximate duration of each session: 15 minutes. The exercises must be supervised by a family member to verify adherence to the programme.
Other: Vestibular rehabil.: home exercises
Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes
No Intervention: Control group
Group D. No vestibular rehabilitation is developed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDP average
Time Frame: 12 months
Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: 12 months
Number of falls after vestibular rehabilitation
12 months
Hospitalisations
Time Frame: 12 months
Hospitalisations due to falls in previous 12 months
12 months
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.
12 months
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.
12 months
Timed-up-and-go time
Time Frame: 12 months
Duration (in seconds) of modified Timed-up-and-go test
12 months
Timed-up-and-go steps
Time Frame: 12 months
Steps to perform the modified Timed-up-and-go test
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Instituto de Salud Carlos III
European Regional Development Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 17, 2014

Study Completion (Actual)

December 17, 2015

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 20, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI11/01328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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