Dizziness Chronic, Elderly, Fall
Conditions
Keywords
Vestibular Rehabilitation, Falls in elderly, Computerized Dynamic Posturography, Optokinetic stimuli
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.
Interventions
DEVICEVestibular rehabil.: CDP
Vestibular rehabilitation, ten sessions
DEVICEVestibular rehabil.: optokinetic stimuli
Vestibular rehabilitation, ten sessions
OTHERVestibular rehabil.: home exercises
Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes
Sponsors
Instituto de Salud Carlos III
European Regional Development Fund
Hospital Clinico Universitario de Santiago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Double (Investigator, Outcomes Assessor) 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.
Intervention model description
Experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 139 elderly patients (over 65 years) with high risk of falls; follow-up period: twelve months.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CDP average | 12 months | Average score in the Sensory Organization Test of the Computerized Dynamic Posturography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalisations | 12 months | Hospitalisations due to falls in previous 12 months |
| DHI score | 12 months | Dizziness Handicap Inventory score; it assesses the disability perceived by the patient in relation to instability. Minimum: 0; maximum: 100. |
| Falls | 12 months | Number of falls after vestibular rehabilitation |
| Timed-up-and-go time | 12 months | Duration (in seconds) of modified Timed-up-and-go test |
| Timed-up-and-go steps | 12 months | Steps to perform the modified Timed-up-and-go test |
| 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. |
Outcome results
None listed