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

Not Applicable

Completed

• Conditions: Dizziness Chronic; Fall; Elderly

• Registration Number: NCT03317353
• Lead Sponsor: Hospital Clinico Universitario de Santiago

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2014-12-17
• Study Completion: 2015-12-17
• Status Verified: 2017-10
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Last Update Submitted: 2017-10-20
• Study First Posted: 2017-10-23
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CDP average	12 months	Average score in the Sensory Organization Test of the Computerized Dynamic Posturography

Secondary Outcome Measures

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