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

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ClinicalTrials.gov Identifier: NCT03034655
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : February 21, 2018
Sponsor:
Collaborators:
Instituto de Salud Carlos III
European Regional Development Fund
Information provided by (Responsible Party):
Andrés Soto-Varela, Hospital Clinico Universitario de Santiago

Brief 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.

Condition or disease Intervention/treatment Phase
Dizziness Chronic Fall Device: CDP Device: Mobile posturography Other: 10 sessions Other: 5 sessions Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation (ReFOVeRe Study): Optimizing Costs
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.
Device: Mobile posturography
Vestibular rehabilitation using mobile posturography
Other Name: Vertiguard's Mobile Posturography

Other: 10 sessions
Vestibular rehabilitation, ten sessions

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).
Device: Mobile posturography
Vestibular rehabilitation using mobile posturography
Other Name: Vertiguard's Mobile Posturography

Other: 5 sessions
Vestibular rehabilitation, five sessions




Primary Outcome Measures :
  1. CDP Average [ Time Frame: 12 months ]
    Average score in the Sensory Organization Test of the Computerized Dynamic Posturography


Secondary Outcome Measures :
  1. Mobile posturografphy gSBDT [ Time Frame: 12 months ]
    Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography

  2. Falls [ Time Frame: 12 months ]
    Number of falls after vestibular rehabilitation

  3. DHI [ Time Frame: 12 months ]
    Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability

  4. Short FES-I [ Time Frame: 12 months ]
    Score of a shortened version of the falls efficacy scale-international to assess fear of falling

  5. TUG [ Time Frame: 12 months ]
    Timed up and go test: time (in seconds), number of steps and need for support



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034655


Contacts
Contact: Andrés Soto-Varela, PhD 0034981951155 andres.soto.varela@sergas.es

Locations
Spain
Complexo Hospitalario Universitario Recruiting
Santiago de Compostela, A Coruña, Spain, 15701
Contact: Andrés Soto-Varela, PhD    0034981951155    andres.soto.varela@sergas.es   
Contact: Sofía Santos-Pérez, PhD    0034981951155    sofia.santos@usc.es   
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         
Sponsors and Collaborators
Hospital Clinico Universitario de Santiago
Instituto de Salud Carlos III
European Regional Development Fund
Investigators
Principal Investigator: Andrés Soto-Varela, PhD Hospital Clinico Universitario de Santiago

Responsible Party: Andrés Soto-Varela, Professor and Attending Physician, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT03034655     History of Changes
Other Study ID Numbers: PI1500329
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrés Soto-Varela, Hospital Clinico Universitario de Santiago:
Vestibular rehabilitation
Falls in elderly
Computerized dynamic posturography
Mobile posturography

Additional relevant MeSH terms:
Dizziness
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms