Dizziness Chronic, Fall
Conditions
Keywords
Vestibular rehabilitation, Falls in elderly, Computerized dynamic posturography, Mobile posturography
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.
Interventions
DEVICECDP
Vestibular rehabilitation using CDP
DEVICEMobile posturography
Vestibular rehabilitation using mobile posturography
OTHER10 sessions
Vestibular rehabilitation, ten sessions
OTHER5 sessions
Vestibular rehabilitation, five sessions
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
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 220 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 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.
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 |
|---|---|---|
| Mobile posturografphy gSBDT | 12 months | Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography |
| Falls | 12 months | Number of falls after vestibular rehabilitation |
| DHI | 12 months | Dizziness Handicap Inventory score; it assesses disability perceived by the patient in relation to instability |
| Short FES-I | 12 months | Score of a shortened version of the falls efficacy scale-international to assess fear of falling |
| TUG | 12 months | Timed up and go test: time (in seconds), number of steps and need for support |
Countries
Spain
Contacts
Primary ContactAndrés Soto-Varela, PhD
Outcome results
None listed