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

Fall Clinical Trial

— ReFOVeRe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03034655
• Other study ID #: PI1500329
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2017
• Last updated: February 20, 2018
• Start date: January 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Hospital Clinico Universitario de Santiago
• Contact: Andrés Soto-Varela, PhD
• Phone: 0034981951155
• Email: andres.soto.varela[@]sergas.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Dizziness Chronic
• Fall

Intervention

Device:
• CDP
Vestibular rehabilitation using CDP
• Mobile posturography
Vestibular rehabilitation using mobile posturography

Other:
• 10 sessions
Vestibular rehabilitation, ten sessions
• 5 sessions
Vestibular rehabilitation, five sessions

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario	Santiago de Compostela	A Coruña

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago	European Regional Development Fund, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDP Average	Average score in the Sensory Organization Test of the Computerized Dynamic Posturography	12 months
Secondary	Mobile posturografphy gSBDT	Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography	12 months
Secondary	Falls	Number of falls after vestibular rehabilitation	12 months
Secondary	DHI	Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability	12 months
Secondary	Short FES-I	Score of a shortened version of the falls efficacy scale-international to assess fear of falling	12 months
Secondary	TUG	Timed up and go test: time (in seconds), number of steps and need for support	12 months