Optimising costs in reducing rate of falls in older people with the improvement of balance by means of vestibular rehabilitation (ReFOVeRe study): a randomized controlled trial comparing computerised dynamic posturography vs mobile vibrotactile posturography system

Abstract

Background: Accidental falls, especially for the elderly, are a major health issue. Balance disorders are one of their main causes. Vestibular rehabilitation (VR) has proven to be useful in improving balance of elderly patients with instability. Its major handicap is probably its cost, which has prevented its generalisation. So, we have designed a clinical trial with posturographic VR, to assess the optimum number of sessions necessary for a substantial improvement and to compare computerised dynamic posturography (CDP) (visual feedback) and mobile posturography (vibrotactile feedback).

Methods: Design: randomized controlled trial. It is an experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 220 elderly patients with high risk of falls; follow-up period: twelve months.

Setting: Department of Otorhinolaryngology of a tertiary referral hospital.

Participants: people over 65 years, fulfilling two or more of the following requirements: a) at least one fall in the last twelve months. b) take at least 16 s or require some support in perform the "timed up and go" test. c) a percentage of average balance in the sensory organization test (SOT) of the CDP < 68%. d) at least one fall in any of the conditions in SOT-CDP. e) a score in Vertiguard's gSBDT > 60%.

Intervention: Four differents protocols of vestibular rehabilitation (randomization of the patients).

Main outcome measure: The percentage of average balance in the SOT-CDP. Secondary measures: time and supports in the "timed up and go" test, scores of the CDP and Vertiguard, and rate of falls.

Discussion: Posturographic VR has been proven to be useful for improving balance and reducing the number of falls among the aged. However, its elevated cost has limited its use. It is possible to implement two strategies that improve the cost-benefit of posturography. The first involves optimising the number of rehabilitation sessions; the second is based on the use of cheaper posturography systems.

Trial registration: ClinicalTrials.gov identifier: NCT03034655. Registered on 25 January 2017.

Keywords: Chronic dizziness; Computerized dynamic posturography; Falls in elderly; Mobile posturography; Vestibular rehabilitation.

Conflict of interest statement

Ethics approval and consent to participate

The protocol has been approved by the Independent Ethics Committee of Galicia (protocol 2014/411). The participants will be given the approved information sheet in order to obtain their written informed consent.

The study will be conducted according to ICH Good Clinical Practices (GCP), the Declaration of Helsinki and Law 14/2007, of 3 July, on Biomedical Research.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Standard protocol items: recommendations for interventional trials (SPIRIT) figure