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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Are there results?
None posted in the registry

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.

Andrés Soto-Varela, PhD contact

0034981951155

andres.soto.varela@sergas.es

Spain1 site, 1 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

    Recruiting

Other trials in Spain

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.

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 groups in NCT03034655
Study groupRoleWhat they receive
CDP exercises (10 sessions)ExperimentalGroup 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)ExperimentalGroup 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)ExperimentalGroup 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)ExperimentalGroup 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.

  1. CDP Average

    Average score in the Sensory Organization Test of the Computerized Dynamic Posturography

    Measured: 12 months

Secondary outcomes (5)

  1. Mobile posturografphy gSBDT

    Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography

    Measured: 12 months

  2. Falls

    Number of falls after vestibular rehabilitation

    Measured: 12 months

  3. DHI

    Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability

    Measured: 12 months

  4. Short FES-I

    Score of a shortened version of the falls efficacy scale-international to assess fear of falling

    Measured: 12 months

  5. 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.

  1. First posted27 Jan 2017 (estimated)
  2. Study start1 Jan 2016
  3. Primary completion31 Aug 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

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)
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 33677737

  • 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.

    PubMed 33250848

  • 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.

    PubMed 32617000

  • 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.

    PubMed 32595593

  • 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.

    PubMed 30606112

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrés Soto-Varela, PhD (0034981951155, andres.soto.varela@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CDP Average (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034655, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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