Dizziness ChronicReFOVeReNCT03034655
Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation (ReFOVeRe Study)
A study testing CDP, Mobile posturography and 10 sessions in people with Dizziness Chronic and Fall, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dizziness Chronic, Fall
- What is being tested?
- CDP, Mobile posturography and 10 sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 %.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complexo Hospitalario Universitario
Santiago de Compostela, A Coruña, 15701
Andrés Soto-Varela, PhD, 0034981951155, andres.soto.varela@sergas.es
Sofía Santos-Pérez, PhD, 0034981951155, sofia.santos@usc.es
About this study
Official title: Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation (ReFOVeRe Study): Optimizing Costs
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.
Read the 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.
- Conditions
- Dizziness Chronic, Fall
- Being tested
- CDP, Mobile posturography, 10 sessions, 5 sessions
- Keywords
- Vestibular rehabilitation, Falls in elderly, Computerized dynamic posturography, Mobile posturography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDPDevice
Also called Computerized Dynamic Posturography
Vestibular rehabilitation using CDP
Mobile posturographyDevice
Also called Vertiguard's Mobile Posturography
Vestibular rehabilitation using mobile posturography
10 sessionsOther
Vestibular rehabilitation, ten sessions
5 sessionsOther
Vestibular rehabilitation, five sessions
| Study group | Role | What they receive |
|---|---|---|
| CDP exercises (10 sessions) | Experimental | 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). Receives: Device: CDP; Other: 10 sessions |
| CDP exercises (5 sessions) | Experimental | 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). Receives: Device: CDP; Other: 5 sessions |
| Mobile posturography exercises (10 sess) | Experimental | 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. Receives: Device: Mobile posturography; Other: 10 sessions |
| Mobile posturography exercises (5 sess) | Experimental | 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). Receives: Device: Mobile posturography; Other: 5 sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDP Average
Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
Measured: 12 months
Secondary outcomes (5)
Mobile posturografphy gSBDT
Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography
Measured: 12 months
Falls
Number of falls after vestibular rehabilitation
Measured: 12 months
DHI
Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability
Measured: 12 months
Short FES-I
Score of a shortened version of the falls efficacy scale-international to assess fear of falling
Measured: 12 months
TUG
Timed up and go test: time (in seconds), number of steps and need for support
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Jan 2016
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dizziness ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Regional Development Fund
- Responsible party
- Principal investigator, Andrés Soto-Varela, Hospital Clinico Universitario de Santiago
- Investigators
- Andrés Soto-Varela, PhD, Principal investigator, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034655
- Sponsor's protocol ID
- PI1500329
- Acronym
- ReFOVeRe
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33677737Soto-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.
PubMed 33250848Soto-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.
PubMed 32617000Soto-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.
PubMed 32595593Soto-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.
PubMed 30606112