NCT03034655

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

January 24, 2017

Last Update Submit

February 20, 2018

Conditions

Dizziness ChronicFall

Keywords

Vestibular rehabilitationFalls in elderlyComputerized dynamic posturographyMobile posturography

Outcome Measures

Primary Outcomes (1)

  • CDP Average

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

    12 months

Secondary Outcomes (5)

  • Mobile posturografphy gSBDT

    12 months

  • Falls

    12 months

  • DHI

    12 months

  • Short FES-I

    12 months

  • TUG

    12 months

Study Arms (4)

CDP exercises (10 sessions)

EXPERIMENTAL

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: CDPOther: 10 sessions

CDP exercises (5 sessions)

EXPERIMENTAL

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: CDPOther: 5 sessions

Mobile posturography exercises (10 sess)

EXPERIMENTAL

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 posturographyOther: 10 sessions

Mobile posturography exercises (5 sess)

EXPERIMENTAL

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 posturographyOther: 5 sessions

Interventions

CDPDEVICE

Vestibular rehabilitation using CDP

Also known as: Computerized Dynamic Posturography
CDP exercises (10 sessions)CDP exercises (5 sessions)
Mobile posturographyDEVICE

Vestibular rehabilitation using mobile posturography

Also known as: Vertiguard's Mobile Posturography
Mobile posturography exercises (10 sess)Mobile posturography exercises (5 sess)
10 sessionsOTHER

Vestibular rehabilitation, ten sessions

CDP exercises (10 sessions)Mobile posturography exercises (10 sess)
5 sessionsOTHER

Vestibular rehabilitation, five sessions

CDP exercises (5 sessions)Mobile posturography exercises (5 sess)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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 %.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complexo Hospitalario Universitario

Santiago de Compostela, A Coruña, 15701, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 33677737DERIVED

  • 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.

    PMID: 33250848DERIVED

  • 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.

    PMID: 32617000DERIVED

  • 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.

    PMID: 32595593DERIVED

  • 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.

    PMID: 30606112DERIVED

Study Officials

  • Andrés Soto-Varela, PhD

    Hospital Clinico Universitario de Santiago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrés Soto-Varela, PhD

CONTACT

0034981951155andres.soto.varela@sergas.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Attending Physician

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 27, 2017

Study Start

January 1, 2016

Primary Completion

August 31, 2018

Study Completion

December 31, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)