Clinical trial NCT03034655: Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation (ReFOVeRe Study)
Official title: Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation (ReFOVeRe Study): Optimizing Costs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dizziness Chronic
Fall
Keywords: Vestibular rehabilitation
Falls in elderly
Computerized dynamic posturography
Mobile posturography
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: European Regional Development Fund
First posted: 2017-01-27
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: CDP Average
timeFrame: 12 months
Secondary outcomes:
measure: Mobile posturografphy gSBDT
timeFrame: 12 months
measure: Falls
timeFrame: 12 months
measure: DHI
timeFrame: 12 months
measure: Short FES-I
timeFrame: 12 months
measure: TUG
timeFrame: 12 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario
state: A Coruña
Study officials:
affiliation: Hospital Clinico Universitario de Santiago
name: Andrés Soto-Varela, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soto-Varela A, Rossi-Izquierdo M, Del-Rio-Valeiras M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Santos-Perez S. Vestibular rehabilitation with mobile posturography as a "low-cost" alternative to vestibular rehabilitation with computerized dynamic posturography, in old people with imbalance: a randomized clinical trial. Aging Clin Exp Res. 2021 Oct;33(10):2807-2819. doi: 10.1007/s40520-021-01813-2. Epub 2021 Mar 7.
citation: Soto-Varela A, Rossi-Izquierdo M, Del-Rio-Valeiras M, Vaamonde-Sanchez-Andrade I, Faraldo-Garcia A, Lirola-Delgado A, Santos-Perez S. Presbyvestibulopathy, Comorbidities, and Perception of Disability: A Cross-Sectional Study. Front Neurol. 2020 Oct 30;11:582038. doi: 10.3389/fneur.2020.582038. eCollection 2020.
citation: Soto-Varela A, Rossi-Izquierdo M, Del-Rio-Valeiras M, Vaamonde-Sanchez-Andrade I, Faraldo-Garcia A, Lirola-Delgado A, Santos-Perez S. Vestibular Rehabilitation Using Posturographic System in Elderly Patients with Postural Instability: Can the Number of Sessions Be Reduced? Clin Interv Aging. 2020 Jun 26;15:991-1001. doi: 10.2147/CIA.S263302. eCollection 2020.
citation: Soto-Varela A, Rossi-Izquierdo M, Del-Rio-Valeiras M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Santos-Perez S. Modified Timed Up and Go Test for Tendency to Fall and Balance Assessment in Elderly Patients With Gait Instability. Front Neurol. 2020 Jun 12;11:543. doi: 10.3389/fneur.2020.00543. eCollection 2020.
citation: Soto-Varela A, Gayoso-Diz P, Faraldo-Garcia A, Rossi-Izquierdo M, Vaamonde-Sanchez-Andrade I, Del-Rio-Valeiras M, Lirola-Delgado A, Santos-Perez S. 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. BMC Geriatr. 2019 Jan 3;19(1):1. doi: 10.1186/s12877-018-1019-5.