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

Not Applicable

• Conditions: Dizziness Chronic; Fall
• Interventions: Device: CDP; Device: Mobile posturography; Other: 5 sessions; Other: 10 sessions

• Registration Number: NCT03034655
• Lead Sponsor: Hospital Clinico Universitario de Santiago

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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-08-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDP exercises (10 sessions)	CDP	Group A. The Smart Equitest program was used with a protocol of 10 exercises per session, which were customized depending on each patient´s deficit. The exercises involve visual biofeedback together with sensitive, real-time monitoring of movement. In some exercises, patients must maintain their center of gravity (COG) over the base of support, while in others the COG must be moved to a series of targets. In addition, the support surface and/or visual surround may also move in response to the patient´s own movement. The exercise difficulty was progressively increased throughout the rehabilitation sessions. The duration of each session was approximately 15 minutes. The distribution of sessions was one per day and five per week (2 weeks).
CDP exercises (5 sessions)	CDP	Group B. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).
Mobile posturography exercises (5 sess)	5 sessions	Group D. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).
CDP exercises (10 sessions)	10 sessions	Group A. The Smart Equitest program was used with a protocol of 10 exercises per session, which were customized depending on each patient´s deficit. The exercises involve visual biofeedback together with sensitive, real-time monitoring of movement. In some exercises, patients must maintain their center of gravity (COG) over the base of support, while in others the COG must be moved to a series of targets. In addition, the support surface and/or visual surround may also move in response to the patient´s own movement. The exercise difficulty was progressively increased throughout the rehabilitation sessions. The duration of each session was approximately 15 minutes. The distribution of sessions was one per day and five per week (2 weeks).
CDP exercises (5 sessions)	5 sessions	Group B. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).
Mobile posturography exercises (10 sess)	Mobile posturography	Group C. Up to six tasks with the most prominent deviations from normative control values were included in the training program. Training was performed by using the training function of Vertiguard1-RT device. This neurofeedback system contains one vibration stimulator on the front, back, left and right side, respectively. Training was performed daily under supervision of a physician over 2 weeks (10 sessions, weekend was excluded). A training session consisted of 5 repetitions of six selected training tasks. The patient received a vibrotactile feedback signal during training in those directions which showed a higher body sway than preset thresholds. Vibration was reinforced with increasing sway No vibrotactile feedback was applied if the patient's sway was below preset thresholds. The exercise difficulty was progressively increase throughout the rehabilitation sessions.
Mobile posturography exercises (10 sess)	10 sessions	Group C. Up to six tasks with the most prominent deviations from normative control values were included in the training program. Training was performed by using the training function of Vertiguard1-RT device. This neurofeedback system contains one vibration stimulator on the front, back, left and right side, respectively. Training was performed daily under supervision of a physician over 2 weeks (10 sessions, weekend was excluded). A training session consisted of 5 repetitions of six selected training tasks. The patient received a vibrotactile feedback signal during training in those directions which showed a higher body sway than preset thresholds. Vibration was reinforced with increasing sway No vibrotactile feedback was applied if the patient's sway was below preset thresholds. The exercise difficulty was progressively increase throughout the rehabilitation sessions.
Mobile posturography exercises (5 sess)	Mobile posturography	Group D. Same as group A, except for the number of sessions (5) and the distribution of sessions (one daily, every other day, two weeks).

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
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
Mobile posturografphy gSBDT	12 months	Geriatric Standard Balance Deficit Test (gSBDT) score in mobile posturography
Falls	12 months	Number of falls after vestibular rehabilitation
TUG	12 months	Timed up and go test: time (in seconds), number of steps and need for support

Trial Locations

Locations (1)

Complexo Hospitalario Universitario; 🇪🇸 Santiago de Compostela, A Coruña, Spain