Dizziness ChronicReFOVeReNCT03317353
Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation: Preliminary Study
A study testing Vestibular rehabil.: CDP, Vestibular rehabil.: optokinetic stimuli and Vestibular rehabil.: home exercises in people with Dizziness Chronic and Fall, run by Hospital Clinico Universitario de Santiago.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dizziness Chronic, Fall, Elderly
- What is being tested?
- Vestibular rehabil.: CDP, Vestibular rehabil.: optokinetic stimuli and Vestibular rehabil.: home exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 17 Dec 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation: Preliminary Study
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.
Read the 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.
- Conditions
- Dizziness Chronic, Fall, Elderly
- Being tested
- Vestibular rehabil.: CDP, Vestibular rehabil.: optokinetic stimuli, Vestibular rehabil.: home exercises
- Keywords
- Vestibular Rehabilitation, Falls in elderly, Computerized Dynamic Posturography, Optokinetic stimuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabil.: CDPDevice
Also called Computerized Dynamic Posturography
Vestibular rehabilitation, ten sessions
Vestibular rehabil.: optokinetic stimuliDevice
Vestibular rehabilitation, ten sessions
Vestibular rehabil.: home exercisesOther
Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Other: Vestibular rehabil.: home exercises |
| Control group | No intervention | Group D. No vestibular rehabilitation is developed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDP average
Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
Measured: 12 months
Secondary outcomes (6)
Falls
Number of falls after vestibular rehabilitation
Measured: 12 months
Hospitalisations
Hospitalisations due to falls in previous 12 months
Measured: 12 months
DHI score
Dizziness Handicap Inventory score; it assesses the disability perceived by the patient in relation to instability. Minimum: 0; maximum: 100.
Measured: 12 months
Short FES-I score
A shortened version of the falls efficacy scale-international to assess fear of falling score. Minimum: 0; maximum: 21.
Measured: 12 months
Timed-up-and-go time
Duration (in seconds) of modified Timed-up-and-go test
Measured: 12 months
Timed-up-and-go steps
Steps to perform the modified Timed-up-and-go test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Jan 2012
- Primary completion17 Dec 2014
- Study completion17 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dizziness ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Regional Development Fund
- Responsible party
- Principal investigator, Andrés Soto-Varela, Hospital Clinico Universitario de Santiago
- Investigators
- Andrés Soto-Varela, PhD, Principal investigator, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317353
- Sponsor's protocol ID
- PI11/01328
- Acronym
- ReFOVeRe
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24916738Soto-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.
PubMed 25194853Soto-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.
PubMed 25911608Rossi-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.
PubMed 26187012del-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.
PubMed 26412554Soto-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.
PubMed 26848036Faraldo-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.
PubMed 27376710Soto-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.
PubMed 28088930Rossi-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.
PubMed 28251319