Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation (ReFOVeRe Study) (ReFOVeRe)

February 20, 2018 updated by: Andrés Soto-Varela, Hospital Clinico Universitario de Santiago

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15701
        • Recruiting
        • Complexo Hospitalario Universitario
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sofía Santos-Pérez, PhD
        • Sub-Investigator:
          • Marcos Rossi-Izquierdo, PhD
        • Sub-Investigator:
          • Ana Faraldo-García, PhD
        • Sub-Investigator:
          • María del-Río-Valeiras, PhD
        • Sub-Investigator:
          • Isabel Vaamonde-Sánchez-Andrade, PhD
        • Sub-Investigator:
          • Antonio Lirola-Delgado, PhD
        • Sub-Investigator:
          • Pilar Gayoso-Diz, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Device: CDP
Vestibular rehabilitation using CDP
Other Names:
  • Computerized Dynamic Posturography
Other: 10 sessions
Vestibular rehabilitation, ten sessions
EXPERIMENTAL: 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).
Device: CDP
Vestibular rehabilitation using CDP
Other Names:
  • Computerized Dynamic Posturography
Other: 5 sessions
Vestibular rehabilitation, five sessions
EXPERIMENTAL: 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.
Other: 10 sessions
Vestibular rehabilitation, ten sessions
Device: Mobile posturography
Vestibular rehabilitation using mobile posturography
Other Names:
  • Vertiguard's Mobile Posturography
EXPERIMENTAL: 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).
Other: 5 sessions
Vestibular rehabilitation, five sessions
Device: Mobile posturography
Vestibular rehabilitation using mobile posturography
Other Names:
  • Vertiguard's Mobile Posturography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDP Average
Time Frame: 12 months
Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: 12 months
Number of falls after vestibular rehabilitation
12 months
Mobile posturografphy gSBDT
Time Frame: 12 months
Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography
12 months
DHI
Time Frame: 12 months
Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability
12 months
Short FES-I
Time Frame: 12 months
Score of a shortened version of the falls efficacy scale-international to assess fear of falling
12 months
TUG
Time Frame: 12 months
Timed up and go test: time (in seconds), number of steps and need for support
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Instituto de Salud Carlos III
European Regional Development Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ANTICIPATED)

August 31, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI1500329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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