Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation (ReFOVeRe Study)
NCT ID: NCT03034655
Last Updated: 2018-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2016-01-01
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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CDP exercises (10 sessions)
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).
CDP
Vestibular rehabilitation using CDP
10 sessions
Vestibular rehabilitation, ten sessions
CDP exercises (5 sessions)
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).
CDP
Vestibular rehabilitation using CDP
5 sessions
Vestibular rehabilitation, five sessions
Mobile posturography exercises (10 sess)
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.
Mobile posturography
Vestibular rehabilitation using mobile posturography
10 sessions
Vestibular rehabilitation, ten sessions
Mobile posturography exercises (5 sess)
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).
Mobile posturography
Vestibular rehabilitation using mobile posturography
5 sessions
Vestibular rehabilitation, five sessions
Interventions
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CDP
Vestibular rehabilitation using CDP
Mobile posturography
Vestibular rehabilitation using mobile posturography
10 sessions
Vestibular rehabilitation, ten sessions
5 sessions
Vestibular rehabilitation, five sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
European Regional Development Fund
OTHER
Hospital Clinico Universitario de Santiago
OTHER
Responsible Party
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Andrés Soto-Varela
Professor and Attending Physician
Principal Investigators
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Andrés Soto-Varela, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario de Santiago
Locations
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Complexo Hospitalario Universitario
Santiago de Compostela, A Coruña, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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PI1500329
Identifier Type: -
Identifier Source: org_study_id
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