Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation: Preliminary Study

Elderly Clinical Trial

— ReFOVeRe  

Official title:

Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation: Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317353
• Other study ID #: PI11/01328
• Status: Completed
• Phase: N/A
• First received: October 18, 2017
• Last updated: October 20, 2017
• Start date: January 1, 2012
• Est. completion date: December 17, 2015

Study information

• Verified date: October 2017
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of vestibular rehabilitation to improve the balance in older people and reduce the number of falls, comparing three arms with different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group.

Description:

Vestibular rehabilitation has been shown to be effective in compensating patients with residual instability as a result of vestibular system disorders or Parkinson's disease. It is also useful for treating lack of balance in the elderly (presbivertigo). However, there is no systematic, controlled and prospective analysis of whether vestibular rehabilitation is effective in reducing the number of falls in the elderly, or whether its effects in this age group are temporary or persist over time.

This study compare vestibular rehabilitation with three different strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group, in people over 65 years. Balance tests are performed before vestibular rehabilitation and three weeks, six months and one year after it. Number of falls are quantified one year after vestibular rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 17, 2015
• Est. primary completion date: December 17, 2014
• 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 one 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 (normal limit calculated in previous studies).

• Obtaining a mean CDP SOT balance score of < 68% (normal limit calculated in previous studies).

• Having fallen at least once in the CDP SOT.

Exclusion Criteria:

• Cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises.

• Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises.

• Balance disorders caused by conditions other than age (neurologic, vestibular...).

• Reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.

Related Conditions & MeSH terms

• Dizziness
• Dizziness Chronic
• Elderly
• Fall

Intervention

Device:
• Vestibular rehabil.: CDP
Vestibular rehabilitation, ten sessions
• Vestibular rehabil.: optokinetic stimuli
Vestibular rehabilitation, ten sessions

Other:
• Vestibular rehabil.: home exercises
Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago	Fondo Europeo de Desarrollo Regional, Instituto de Salud Carlos III

References & Publications (9)

del-Río-Valeiras M, Gayoso-Diz P, Santos-Pérez S, Rossi-Izquierdo M, Faraldo-García A, Vaamonde-Sánchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Is there a relationship between short FES-I test scores and objective assessment of balance in the older pe — View Citation

Faraldo-García A, Santos-Pérez S, Rossi-Izquierdo M, Lirola-Delgado A, Vaamonde-Sánchez-Andrade I, Del-Río-Valeiras M, Soto-Varela A. Posturographic limits of stability can predict the increased risk of falls in elderly patients with instability? Acta Oto — View Citation

Rossi-Izquierdo M, Gayoso-Diz P, Santos-Pérez S, Del-Río-Valeiras M, Faraldo-García A, Vaamonde-Sánchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Short-term effectiveness of vestibular rehabilitation in elderly patients with postural instability: a rand — View Citation

Rossi-Izquierdo M, Santos-Pérez S, Del-Río-Valeiras M, Lirola-Delgado A, Faraldo-García A, Vaamonde-Sánchez-Andrade I, Gayoso-Diz P, Soto-Varela A. Is there a relationship between objective and subjective assessment of balance in elderly patients with ins — View Citation

Rossi-Izquierdo M, Santos-Pérez S, Faraldo-García A, Vaamonde-Sánchez-Andrade I, Gayoso-Diz P, Del-Río-Valeiras M, Lirola-Delgado A, Soto-Varela A. Impact of obesity in elderly patients with postural instability. Aging Clin Exp Res. 2016 Jun;28(3):423-8. — View Citation

Soto-Varela A, Faraldo-García A, Del-Río-Valeiras M, Rossi-Izquierdo M, Vaamonde-Sánchez-Andrade I, Gayoso-Diz P, Lirola-Delgado A, Santos-Pérez S. Adherence of older people with instability in vestibular rehabilitation programmes: prediction criteria. J — View Citation

Soto-Varela A, Faraldo-García A, Rossi-Izquierdo M, Lirola-Delgado A, Vaamonde-Sánchez-Andrade I, del-Río-Valeiras M, Gayoso-Diz P, Santos-Pérez S. Can we predict the risk of falls in elderly patients with instability? Auris Nasus Larynx. 2015 Feb;42(1):8 — View Citation

Soto-Varela A, Gayoso-Diz P, Rossi-Izquierdo M, Faraldo-García A, Vaamonde-Sánchez-Andrade I, del-Río-Valeiras M, Lirola-Delgado A, Santos-Pérez S. Reduction of falls in older people by improving balance with vestibular rehabilitation (ReFOVeRe study): de — View Citation

Soto-Varela A, Rossi-Izquierdo M, Faraldo-García A, Vaamonde-Sánchez-Andrade I, Gayoso-Diz P, Del-Río-Valeiras M, Lirola-Delgado A, Santos-Pérez S. Balance Disorders in the Elderly: Does Instability Increase Over Time? Ann Otol Rhinol Laryngol. 2016 Jul;1 — View Citation

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	Falls	Number of falls after vestibular rehabilitation	12 months
Secondary	Hospitalisations	Hospitalisations due to falls in previous 12 months	12 months
Secondary	DHI score	Dizziness Handicap Inventory score; it assesses the disability perceived by the patient in relation to instability. Minimum: 0; maximum: 100.	12 months
Secondary	Short FES-I score	A shortened version of the falls efficacy scale-international to assess fear of falling score. Minimum: 0; maximum: 21.	12 months
Secondary	Timed-up-and-go time	Duration (in seconds) of modified Timed-up-and-go test	12 months
Secondary	Timed-up-and-go steps	Steps to perform the modified Timed-up-and-go test	12 months