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

NCT03317353 | Completed

• 1 other identifier: PI11/01328
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dizziness Chronic; Fall; Elderly

Keywords

Vestibular Rehabilitation; Falls in elderly; Computerized Dynamic Posturography; Optokinetic stimuli

Outcome Measures

Primary Outcomes (1)

• CDP average

  Average score in the Sensory Organization Test of the Computerized Dynamic Posturography

  12 months

Secondary Outcomes (6)

• Falls

  12 months

• Hospitalisations

  12 months

• DHI score

  12 months

• Short FES-I score

  12 months

• Timed-up-and-go time

  12 months

Study Arms (4)

Vestibular rehabil.: CDP

EXPERIMENTAL

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).

Device: Vestibular rehabil.: CDP

Vestibular rehabil.: optokinetic stimuli

EXPERIMENTAL

Group B. Patient has to stand in a dark room, wiht optokinetic stimuli around him/her. Ten sessions (one per day, five per week, two weeks), with progressive increase of stimulus speed (from 30º/sec the first day to 100º/sec the last), duration of session (from 5 minutes the first day to 15 minutes the last), stimulus complexity (horizontal stimuli in the first sessions, progressively adding vertical and rotating stimuli) and support surface difficulty (initially hard surface, last sessions on foam).

Device: Vestibular rehabil.: optokinetic stimuli

Vestibular rehabil.: home exercises

EXPERIMENTAL

Group C. The patient is given a list of exercises (and explained how to do them) to stabilise eye position and improve postural control. They are to be performed twice a day for two weeks. Approximate duration of each session: 15 minutes. The exercises must be supervised by a family member to verify adherence to the programme.

Other: Vestibular rehabil.: home exercises

Control group

NO INTERVENTION

Group D. No vestibular rehabilitation is developed.

Interventions

Vestibular rehabil.: CDP DEVICE

Vestibular rehabilitation, ten sessions

Also known as: Computerized Dynamic Posturography

Vestibular rehabil.: CDP

Vestibular rehabil.: optokinetic stimuli DEVICE

Vestibular rehabilitation, ten sessions

Vestibular rehabil.: optokinetic stimuli

Vestibular rehabil.: home exercises OTHER

Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes

Vestibular rehabil.: home exercises

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Instituto de Salud Carlos III: collaborator
• European Regional Development Fund: collaborator

Related Publications (9)

• Rossi-Izquierdo M, Santos-Perez S, Del-Rio-Valeiras M, Lirola-Delgado A, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Soto-Varela A. Is there a relationship between objective and subjective assessment of balance in elderly patients with instability? Eur Arch Otorhinolaryngol. 2015 Sep;272(9):2201-6. doi: 10.1007/s00405-014-3122-3. Epub 2014 Jun 12.

  PMID: 24916738 RESULT

• Soto-Varela A, Faraldo-Garcia A, Rossi-Izquierdo M, Lirola-Delgado A, Vaamonde-Sanchez-Andrade I, del-Rio-Valeiras M, Gayoso-Diz P, Santos-Perez S. Can we predict the risk of falls in elderly patients with instability? Auris Nasus Larynx. 2015 Feb;42(1):8-14. doi: 10.1016/j.anl.2014.06.005. Epub 2014 Sep 4.

  PMID: 25194853 RESULT

• Soto-Varela A, Gayoso-Diz P, Rossi-Izquierdo M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, del-Rio-Valeiras M, Lirola-Delgado A, Santos-Perez S. Reduction of falls in older people by improving balance with vestibular rehabilitation (ReFOVeRe study): design and methods. Aging Clin Exp Res. 2015 Dec;27(6):841-8. doi: 10.1007/s40520-015-0362-z. Epub 2015 Apr 25.

  PMID: 25911608 RESULT

• Rossi-Izquierdo M, Santos-Perez S, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Del-Rio-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. doi: 10.1007/s40520-015-0414-4. Epub 2015 Jul 18.

  PMID: 26187012 RESULT

• del-Rio-Valeiras M, Gayoso-Diz P, Santos-Perez S, Rossi-Izquierdo M, Faraldo-Garcia A, Vaamonde-Sanchez-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 people with age-induced instability? Arch Gerontol Geriatr. 2016 Jan-Feb;62:90-6. doi: 10.1016/j.archger.2015.09.005. Epub 2015 Sep 18.

  PMID: 26412554 RESULT

• Soto-Varela A, Rossi-Izquierdo M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Del-Rio-Valeiras M, Lirola-Delgado A, Santos-Perez S. Balance Disorders in the Elderly: Does Instability Increase Over Time? Ann Otol Rhinol Laryngol. 2016 Jul;125(7):550-8. doi: 10.1177/0003489416629979. Epub 2016 Feb 4.

  PMID: 26848036 RESULT

• Faraldo-Garcia A, Santos-Perez S, Rossi-Izquierdo M, Lirola-Delgado A, Vaamonde-Sanchez-Andrade I, Del-Rio-Valeiras M, Soto-Varela A. Posturographic limits of stability can predict the increased risk of falls in elderly patients with instability? Acta Otolaryngol. 2016 Nov;136(11):1125-1129. doi: 10.1080/00016489.2016.1201591. Epub 2016 Jul 4.

  PMID: 27376710 RESULT

• Soto-Varela A, Faraldo-Garcia A, Del-Rio-Valeiras M, Rossi-Izquierdo M, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Lirola-Delgado A, Santos-Perez S. Adherence of older people with instability in vestibular rehabilitation programmes: prediction criteria. J Laryngol Otol. 2017 Mar;131(3):232-238. doi: 10.1017/S0022215116009932. Epub 2017 Jan 16.

  PMID: 28088930 RESULT

• Rossi-Izquierdo M, Gayoso-Diz P, Santos-Perez S, Del-Rio-Valeiras M, Faraldo-Garcia A, Vaamonde-Sanchez-Andrade I, Lirola-Delgado A, Soto-Varela A. Short-term effectiveness of vestibular rehabilitation in elderly patients with postural instability: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2395-2403. doi: 10.1007/s00405-017-4472-4. Epub 2017 Mar 1.

  PMID: 28251319 RESULT

Study Officials

• Andrés Soto-Varela, PhD

  Hospital Clinico Universitario de Santiago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Attending Physician

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: January 1, 2012
• Primary Completion: December 17, 2014
• Study Completion: December 17, 2015
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share