search
Back to results

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

Primary Purpose

Dizziness Chronic, Fall, Elderly

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vestibular rehabil.: CDP
Vestibular rehabil.: optokinetic stimuli
Vestibular rehabil.: home exercises
Sponsored by
Hospital Clinico Universitario de Santiago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dizziness Chronic focused on measuring Vestibular Rehabilitation, Falls in elderly, Computerized Dynamic Posturography, Optokinetic stimuli

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Persons with a high risk of falling shall meet at least one 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 (normal limit calculated in previous studies).
  • Obtaining a mean CDP SOT balance score of < 68% (normal limit calculated in previous studies).
  • Having fallen at least once in the CDP SOT.

Exclusion Criteria:

  • Cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises.
  • Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises.
  • Balance disorders caused by conditions other than age (neurologic, vestibular...).
  • Reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Vestibular rehabil.: CDP

    Vestibular rehabil.: optokinetic stimuli

    Vestibular rehabil.: home exercises

    Control group

    Arm Description

    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).

    Group B. Patient has to stand in a dark room, wiht optokinetic stimuli around him/her. Ten sessions (one per day, five per week, two weeks), with progressive increase of stimulus speed (from 30º/sec the first day to 100º/sec the last), duration of session (from 5 minutes the first day to 15 minutes the last), stimulus complexity (horizontal stimuli in the first sessions, progressively adding vertical and rotating stimuli) and support surface difficulty (initially hard surface, last sessions on foam).

    Group C. The patient is given a list of exercises (and explained how to do them) to stabilise eye position and improve postural control. They are to be performed twice a day for two weeks. Approximate duration of each session: 15 minutes. The exercises must be supervised by a family member to verify adherence to the programme.

    Group D. No vestibular rehabilitation is developed.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Falls
    Number of falls after vestibular rehabilitation
    Hospitalisations
    Hospitalisations due to falls in previous 12 months
    DHI score
    Dizziness Handicap Inventory score; it assesses the disability perceived by the patient in relation to instability. Minimum: 0; maximum: 100.
    Short FES-I score
    A shortened version of the falls efficacy scale-international to assess fear of falling score. Minimum: 0; maximum: 21.
    Timed-up-and-go time
    Duration (in seconds) of modified Timed-up-and-go test
    Timed-up-and-go steps
    Steps to perform the modified Timed-up-and-go test

    Full Information

    First Posted
    October 18, 2017
    Last Updated
    October 20, 2017
    Sponsor
    Hospital Clinico Universitario de Santiago
    Collaborators
    Instituto de Salud Carlos III, European Regional Development Fund
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03317353
    Brief Title
    Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation: Preliminary Study
    Acronym
    ReFOVeRe
    Official Title
    Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation: Preliminary Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    December 17, 2014 (Actual)
    Study Completion Date
    December 17, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Clinico Universitario de Santiago
    Collaborators
    Instituto de Salud Carlos III, European Regional Development Fund

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the effectiveness of vestibular rehabilitation to improve the balance in older people and reduce the number of falls, comparing three arms with different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group.
    Detailed Description
    Vestibular rehabilitation has been shown to be effective in compensating patients with residual instability as a result of vestibular system disorders or Parkinson's disease. It is also useful for treating lack of balance in the elderly (presbivertigo). However, there is no systematic, controlled and prospective analysis of whether vestibular rehabilitation is effective in reducing the number of falls in the elderly, or whether its effects in this age group are temporary or persist over time. This study compare vestibular rehabilitation with three different strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group, in people over 65 years. Balance tests are performed before vestibular rehabilitation and three weeks, six months and one year after it. Number of falls are quantified one year after vestibular rehabilitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dizziness Chronic, Fall, Elderly
    Keywords
    Vestibular Rehabilitation, Falls in elderly, Computerized Dynamic Posturography, Optokinetic stimuli

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 139 elderly patients (over 65 years) with high risk of falls; follow-up period: twelve months.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Double (Investigator, Outcomes Assessor) After the first screening visit, the patients who grant their consent will be included in the study and randomised to one of the following study arms. Randomisation will be performed by C.H.U de Santiago Clinical Epidemiology and Biostatistics Unit. Once the informed consent form is signed, the care provider will contact the unit, which will give him the code of the arm to which the patient is assigned. A n= 20 block balanced randomisation sequence will be used. The investigator will analyse results and evolution, being blind type and duration of vestibular rehabilitation.
    Allocation
    Randomized
    Enrollment
    139 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vestibular rehabil.: CDP
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Vestibular rehabil.: optokinetic stimuli
    Arm Type
    Experimental
    Arm Description
    Group B. Patient has to stand in a dark room, wiht optokinetic stimuli around him/her. Ten sessions (one per day, five per week, two weeks), with progressive increase of stimulus speed (from 30º/sec the first day to 100º/sec the last), duration of session (from 5 minutes the first day to 15 minutes the last), stimulus complexity (horizontal stimuli in the first sessions, progressively adding vertical and rotating stimuli) and support surface difficulty (initially hard surface, last sessions on foam).
    Arm Title
    Vestibular rehabil.: home exercises
    Arm Type
    Experimental
    Arm Description
    Group C. The patient is given a list of exercises (and explained how to do them) to stabilise eye position and improve postural control. They are to be performed twice a day for two weeks. Approximate duration of each session: 15 minutes. The exercises must be supervised by a family member to verify adherence to the programme.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Group D. No vestibular rehabilitation is developed.
    Intervention Type
    Device
    Intervention Name(s)
    Vestibular rehabil.: CDP
    Other Intervention Name(s)
    Computerized Dynamic Posturography
    Intervention Description
    Vestibular rehabilitation, ten sessions
    Intervention Type
    Device
    Intervention Name(s)
    Vestibular rehabil.: optokinetic stimuli
    Intervention Description
    Vestibular rehabilitation, ten sessions
    Intervention Type
    Other
    Intervention Name(s)
    Vestibular rehabil.: home exercises
    Intervention Description
    Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes
    Primary Outcome Measure Information:
    Title
    CDP average
    Description
    Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Falls
    Description
    Number of falls after vestibular rehabilitation
    Time Frame
    12 months
    Title
    Hospitalisations
    Description
    Hospitalisations due to falls in previous 12 months
    Time Frame
    12 months
    Title
    DHI score
    Description
    Dizziness Handicap Inventory score; it assesses the disability perceived by the patient in relation to instability. Minimum: 0; maximum: 100.
    Time Frame
    12 months
    Title
    Short FES-I score
    Description
    A shortened version of the falls efficacy scale-international to assess fear of falling score. Minimum: 0; maximum: 21.
    Time Frame
    12 months
    Title
    Timed-up-and-go time
    Description
    Duration (in seconds) of modified Timed-up-and-go test
    Time Frame
    12 months
    Title
    Timed-up-and-go steps
    Description
    Steps to perform the modified Timed-up-and-go test
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Persons with a high risk of falling shall meet at least one 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 (normal limit calculated in previous studies). Obtaining a mean CDP SOT balance score of < 68% (normal limit calculated in previous studies). Having fallen at least once in the CDP SOT. Exclusion Criteria: Cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises. Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises. Balance disorders caused by conditions other than age (neurologic, vestibular...). Reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrés Soto-Varela, PhD
    Organizational Affiliation
    Hospital Clinico Universitario de Santiago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24916738
    Citation
    Rossi-Izquierdo M, Santos-Perez S, Del-Rio-Valeiras M, Lirola-Delgado A, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Soto-Varela A. Is there a relationship between objective and subjective assessment of balance in elderly patients with instability? Eur Arch Otorhinolaryngol. 2015 Sep;272(9):2201-6. doi: 10.1007/s00405-014-3122-3. Epub 2014 Jun 12.
    Results Reference
    result
    PubMed Identifier
    25194853
    Citation
    Soto-Varela A, Faraldo-Garcia A, Rossi-Izquierdo M, Lirola-Delgado A, Vaamonde-Sanchez-Andrade I, del-Rio-Valeiras M, Gayoso-Diz P, Santos-Perez S. Can we predict the risk of falls in elderly patients with instability? Auris Nasus Larynx. 2015 Feb;42(1):8-14. doi: 10.1016/j.anl.2014.06.005. Epub 2014 Sep 4.
    Results Reference
    result
    PubMed Identifier
    25911608
    Citation
    Soto-Varela A, Gayoso-Diz P, Rossi-Izquierdo M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, del-Rio-Valeiras M, Lirola-Delgado A, Santos-Perez S. Reduction of falls in older people by improving balance with vestibular rehabilitation (ReFOVeRe study): design and methods. Aging Clin Exp Res. 2015 Dec;27(6):841-8. doi: 10.1007/s40520-015-0362-z. Epub 2015 Apr 25.
    Results Reference
    result
    PubMed Identifier
    26187012
    Citation
    Rossi-Izquierdo M, Santos-Perez S, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Del-Rio-Valeiras M, Lirola-Delgado A, Soto-Varela A. Impact of obesity in elderly patients with postural instability. Aging Clin Exp Res. 2016 Jun;28(3):423-8. doi: 10.1007/s40520-015-0414-4. Epub 2015 Jul 18.
    Results Reference
    result
    PubMed Identifier
    26412554
    Citation
    del-Rio-Valeiras M, Gayoso-Diz P, Santos-Perez S, Rossi-Izquierdo M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Is there a relationship between short FES-I test scores and objective assessment of balance in the older people with age-induced instability? Arch Gerontol Geriatr. 2016 Jan-Feb;62:90-6. doi: 10.1016/j.archger.2015.09.005. Epub 2015 Sep 18.
    Results Reference
    result
    PubMed Identifier
    26848036
    Citation
    Soto-Varela A, Rossi-Izquierdo M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Del-Rio-Valeiras M, Lirola-Delgado A, Santos-Perez S. Balance Disorders in the Elderly: Does Instability Increase Over Time? Ann Otol Rhinol Laryngol. 2016 Jul;125(7):550-8. doi: 10.1177/0003489416629979. Epub 2016 Feb 4.
    Results Reference
    result
    PubMed Identifier
    27376710
    Citation
    Faraldo-Garcia A, Santos-Perez S, Rossi-Izquierdo M, Lirola-Delgado A, Vaamonde-Sanchez-Andrade I, Del-Rio-Valeiras M, Soto-Varela A. Posturographic limits of stability can predict the increased risk of falls in elderly patients with instability? Acta Otolaryngol. 2016 Nov;136(11):1125-1129. doi: 10.1080/00016489.2016.1201591. Epub 2016 Jul 4.
    Results Reference
    result
    PubMed Identifier
    28088930
    Citation
    Soto-Varela A, Faraldo-Garcia A, Del-Rio-Valeiras M, Rossi-Izquierdo M, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Lirola-Delgado A, Santos-Perez S. Adherence of older people with instability in vestibular rehabilitation programmes: prediction criteria. J Laryngol Otol. 2017 Mar;131(3):232-238. doi: 10.1017/S0022215116009932. Epub 2017 Jan 16.
    Results Reference
    result
    PubMed Identifier
    28251319
    Citation
    Rossi-Izquierdo M, Gayoso-Diz P, Santos-Perez S, Del-Rio-Valeiras M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Short-term effectiveness of vestibular rehabilitation in elderly patients with postural instability: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2395-2403. doi: 10.1007/s00405-017-4472-4. Epub 2017 Mar 1.
    Results Reference
    result

    Learn more about this trial

    Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation: Preliminary Study

    We'll reach out to this number within 24 hrs