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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dizziness Chronic, Fall, Elderly

Intervention / Treatment
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* Device: Vestibular rehabil.: CDP
* Device: Vestibular rehabil.: optokinetic stimuli
* Other: Vestibular rehabil.: home exercises


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 139 elderly patients (over 65 years) with high risk of falls; follow-up period: twelve months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular rehabil.: CDP<br>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<br>* Vestibular rehabilitation, ten sessions<br>* Other names: Computerized Dynamic Posturography;|
| Experimental: Vestibular rehabil.: optokinetic stimuli<br>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<br>* Vestibular rehabilitation, ten sessions<br>|
| Experimental: Vestibular rehabil.: home exercises<br>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<br>* Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes<br>|
| No Intervention: Control group<br>Group D. No vestibular rehabilitation is developed. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vestibular Rehabilitation, Falls in elderly, Computerized Dynamic Posturography, Optokinetic stimuli