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

Not Applicable
Conditions
Dizziness Chronic
Fall
Registration Number
NCT03034655
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
220
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
CDP Average12 months

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

Secondary Outcome Measures
NameTimeMethod
DHI12 months

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

Short FES-I12 months

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

Mobile posturografphy gSBDT12 months

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

Falls12 months

Number of falls after vestibular rehabilitation

TUG12 months

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

Trial Locations

Locations (1)

Complexo Hospitalario Universitario

🇪🇸

Santiago de Compostela, A Coruña, Spain

Complexo Hospitalario Universitario
🇪🇸Santiago de Compostela, A Coruña, Spain
Andrés Soto-Varela, PhD
Contact
0034981951155
andres.soto.varela@sergas.es
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
Sub Investigator

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