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

Primary Purpose

Dizziness Chronic, Fall

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

CDP

Mobile posturography

10 sessions

5 sessions

About this trial

This is an interventional prevention trial for Dizziness Chronic focused on measuring Vestibular rehabilitation, Falls in elderly, Computerized dynamic posturography, Mobile posturography

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 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.

Sites / Locations

Complexo Hospitalario UniversitarioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

CDP exercises (10 sessions)

CDP exercises (5 sessions)

Mobile posturography exercises (10 sess)

Mobile posturography exercises (5 sess)

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. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).

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.

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).

Outcomes

Primary Outcome Measures

CDP Average

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

Secondary Outcome Measures

Mobile posturografphy gSBDT

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

Falls

Number of falls after vestibular rehabilitation

DHI

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

Short FES-I

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

TUG

Timed up and go test: time (in seconds), number of steps and need for support

Full Information

NCT ID

NCT03034655

First Posted

January 24, 2017

Last Updated

February 20, 2018

Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Instituto de Salud Carlos III, European Regional Development Fund

1. Study Identification

Unique Protocol Identification Number

NCT03034655

Brief Title

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

Acronym

ReFOVeRe

Official Title

Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation (ReFOVeRe Study): Optimizing Costs

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

August 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dizziness Chronic, Fall

Keywords

Vestibular rehabilitation, Falls in elderly, Computerized dynamic posturography, Mobile posturography

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 220 elderly patients (over 65 years) with high risk of falls; follow-up period: twelve months.

Masking

InvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CDP exercises (10 sessions)

Arm Type

Experimental

Arm Description

Arm Title

CDP exercises (5 sessions)

Arm Type

Experimental

Arm Description

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).

Arm Title

Mobile posturography exercises (10 sess)

Arm Type

Experimental

Arm Description

Arm Title

Mobile posturography exercises (5 sess)

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

CDP

Other Intervention Name(s)

Computerized Dynamic Posturography

Intervention Description

Vestibular rehabilitation using CDP

Intervention Type

Device

Intervention Name(s)

Mobile posturography

Other Intervention Name(s)

Vertiguard's Mobile Posturography

Intervention Description

Vestibular rehabilitation using mobile posturography

Intervention Type

Other

Intervention Name(s)

10 sessions

Intervention Description

Vestibular rehabilitation, ten sessions

Intervention Type

Other

Intervention Name(s)

5 sessions

Intervention Description

Vestibular rehabilitation, five sessions

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

Mobile posturografphy gSBDT

Description

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

Time Frame

12 months

Title

Falls

Description

Number of falls after vestibular rehabilitation

Time Frame

12 months

Title

DHI

Description

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

Time Frame

12 months

Title

Short FES-I

Description

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

Time Frame

12 months

Title

TUG

Description

Timed up and go test: time (in seconds), number of steps and need for support

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrés Soto-Varela, PhD

Phone

0034981951155

andres.soto.varela@sergas.es

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

Facility Information:

Facility Name

Complexo Hospitalario Universitario

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

15701

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrés Soto-Varela, PhD

Phone

0034981951155

andres.soto.varela@sergas.es

First Name & Middle Initial & Last Name & Degree

Sofía Santos-Pérez, PhD

Phone

0034981951155

sofia.santos@usc.es

First Name & Middle Initial & Last Name & Degree

Sofía Santos-Pérez, PhD

First Name & Middle Initial & Last Name & Degree

Marcos Rossi-Izquierdo, PhD

First Name & Middle Initial & Last Name & Degree

Ana Faraldo-García, PhD

First Name & Middle Initial & Last Name & Degree

María del-Río-Valeiras, PhD

First Name & Middle Initial & Last Name & Degree

Isabel Vaamonde-Sánchez-Andrade, PhD

First Name & Middle Initial & Last Name & Degree

Antonio Lirola-Delgado, PhD

First Name & Middle Initial & Last Name & Degree

Pilar Gayoso-Diz, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33677737

Citation

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.

Results Reference

derived

PubMed Identifier

33250848

Citation

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.

Results Reference

derived

PubMed Identifier

32617000

Citation

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.

Results Reference

derived

PubMed Identifier

32595593

Citation

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.

Results Reference

derived

PubMed Identifier

30606112

Citation

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.

Results Reference

derived

Learn more about this trial

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

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