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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dizziness Chronic, Fall

Intervention / Treatment
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* Device: CDP
* Device: Mobile posturography
* Other: 10 sessions
* Other: 5 sessions


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 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.

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 220 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: CDP exercises (10 sessions)<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: CDP<br>* Vestibular rehabilitation using CDP<br>* Other names: Computerized Dynamic Posturography;Other: 10 sessions<br>* Vestibular rehabilitation, ten sessions<br>|
| Experimental: CDP exercises (5 sessions)<br>Group B. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks). | Device: CDP<br>* Vestibular rehabilitation using CDP<br>* Other names: Computerized Dynamic Posturography;Other: 5 sessions<br>* Vestibular rehabilitation, five sessions<br>|
| Experimental: Mobile posturography exercises (10 sess)<br>Group C. Up to six tasks with the most prominent deviations from normative control values were included in the training program. Training was performed by using the training function of Vertiguard1-RT device. This neurofeedback system contains one vibration stimulator on the front, back, left and right side, respectively. Training was performed daily under supervision of a physician over 2 weeks (10 sessions, weekend was excluded). A training session consisted of 5 repetitions of six selected training tasks. The patient received a vibrotactile feedback signal during training in those directions which showed a higher body sway than preset thresholds. Vibration was reinforced with increasing sway No vibrotactile feedback was applied if the patient's sway was below preset thresholds. The exercise difficulty was progressively increase throughout the rehabilitation sessions. | Device: Mobile posturography<br>* Vestibular rehabilitation using mobile posturography<br>* Other names: Vertiguard's Mobile Posturography;Other: 10 sessions<br>* Vestibular rehabilitation, ten sessions<br>|
| Experimental: Mobile posturography exercises (5 sess)<br>Group D. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks). | Device: Mobile posturography<br>* Vestibular rehabilitation using mobile posturography<br>* Other names: Vertiguard's Mobile Posturography;Other: 5 sessions<br>* Vestibular rehabilitation, five sessions<br>|

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 |
| --- | --- | --- |
| Mobile posturografphy gSBDT | Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography | 12 months | 
| Falls | Number of falls after vestibular rehabilitation | 12 months | 
| DHI | Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability | 12 months | 
| Short FES-I | Score of a shortened version of the falls efficacy scale-international to assess fear of falling | 12 months | 
| TUG | Timed up and go test: time (in seconds), number of steps and need for support | 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, Mobile posturography