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Metabolic and Chronobiological Changes in Vestibular Rehabilitation

NCT ID: NCT05174104

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-01

Brief Summary

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The aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means of bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinical validated scales

Detailed Description

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Recent advances in the field of vestibular-related disorders demonstrated that such conditions may interfere on different pathways underpinning metabolic behaviour, daily life activities and also chronotype behaviour. However, no studies evaluated how vestibular rehabilitation procedures - well established in literature - may interfere on these vestibular-related disorders. On the other side, recent advances in portable bioelectrical impedenzometry devices, smart watches devised to evaluate energy expenditure during daily life activities and actigraphy devices demonstrated to be useful in continuously monitoring different aspects of metabolic, activity and sleep behaviour.

Thus, the aim of the present study is to evaluate the impact of vestibular rehabilitation on metabolic aspects when evaluated by means bioelectrical impedenzometry analysis, smart watch device and actigraphy in a group of vestibular hypofunction patients previously studied by means of video head impulse test, posturography and clinically validated scales

Conditions

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Vestibular Disorder Metabolic Disease Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Early Vestibular Rehabilitation

This group will undergo a 4 weeks of vestibular rehabilitation in the first month and then it will be only followed up in the second month

Group Type EXPERIMENTAL

Vestibular Rehabilitation

Intervention Type PROCEDURE

The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day

Delayed Vestibular Rehabilitation

This group will be followed-up for the first month and the it will undergo 4 weeks of vestibular rehabilitation in the second month

Group Type EXPERIMENTAL

Vestibular Rehabilitation

Intervention Type PROCEDURE

The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day

Interventions

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Vestibular Rehabilitation

The home exercise schedule consists of a patient-tailored association of adaptation (without and with the target moving on pitch and yaw planes for 1 min each three times per day), substitution, habituation, and balance and gait exercises. All the unilateral vestibular hypofunction patients will be followed in the clinic twice a week for 4 weeks for 30-45 min and evaluated for adherence. Between supervised sessions, patients will perform a twice-daily home exercise plan for a total of 30-40 min/day

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* unilateral vestibular hypofunction achieved according to accepted criteria, by bithermal caloric irrigation, showing at least 25% reduced vestibular response on one side when calculated by means of Jongkees' formula, 3 months or later after symptom onset. In order to avoid confounding factors, and following previous experiences, only subjects presenting with a concurrent reduction in vestibulo-ocular reflex (VOR) gain when studied by means of video head impulse test will be included in this study.

Exclusion Criteria

* History of falls, cardiovascular, metabolic, rheumatologic, orthopedic, or other neurological conditions, liver or renal abnormalities.
* pregnancy or breastfeeding.
* Neurological and neuro-psychiatric diseases
* insulin-dependent diabetes, vitamin deficiencies, hypothyroidism, lung diseases, hepatitis, chronic kidney failure, and Cushing syndrome
* medication possibly impacting on cochleo-vestibular function or with a history of drug or alcohol addiction
* inability to understand and agree to the examination procedures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uniter Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ITER Center for Balance and Rehabilitation Research

Guidonia, Rome, Italy

Site Status

Countries

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Italy

References

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Herdman SJ, Blatt PJ, Schubert MC. Vestibular rehabilitation of patients with vestibular hypofunction or with benign paroxysmal positional vertigo. Curr Opin Neurol. 2000 Feb;13(1):39-43. doi: 10.1097/00019052-200002000-00008.

Reference Type BACKGROUND
PMID: 10719648 (View on PubMed)

Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.

Reference Type BACKGROUND
PMID: 34864777 (View on PubMed)

Micarelli A, Viziano A, Pistillo R, Granito I, Micarelli B, Alessandrini M. Sleep Performance and Chronotype Behavior in Unilateral Vestibular Hypofunction. Laryngoscope. 2021 Oct;131(10):2341-2347. doi: 10.1002/lary.29719. Epub 2021 Jun 30.

Reference Type BACKGROUND
PMID: 34191310 (View on PubMed)

Micarelli A, Viziano A, Micarelli B, Augimeri I, Alessandrini M. Vestibular rehabilitation in older adults with and without mild cognitive impairment: Effects of virtual reality using a head-mounted display. Arch Gerontol Geriatr. 2019 Jul-Aug;83:246-256. doi: 10.1016/j.archger.2019.05.008. Epub 2019 May 10.

Reference Type BACKGROUND
PMID: 31102927 (View on PubMed)

Alessandrini M, Viziano A, Pistillo R, Granito I, Basso L, Preziosi N, Micarelli A. Changes in daily energy expenditure and movement behavior in unilateral vestibular hypofunction: Relationships with neuro-otological parameters. J Clin Neurosci. 2021 Sep;91:200-208. doi: 10.1016/j.jocn.2021.07.012. Epub 2021 Jul 17.

Reference Type BACKGROUND
PMID: 34373028 (View on PubMed)

Micarelli A, Viziano A, Granito I, Micarelli RX, Felicioni A, Alessandrini M. Changes in body composition in unilateral vestibular hypofunction: relationships between bioelectrical impedance analysis and neuro-otological parameters. Eur Arch Otorhinolaryngol. 2021 Jul;278(7):2603-2611. doi: 10.1007/s00405-020-06561-z. Epub 2021 Jan 3.

Reference Type BACKGROUND
PMID: 33392761 (View on PubMed)

Micarelli A, Viziano A, Augimeri I, Micarelli D, Alessandrini M. Three-dimensional head-mounted gaming task procedure maximizes effects of vestibular rehabilitation in unilateral vestibular hypofunction: a randomized controlled pilot trial. Int J Rehabil Res. 2017 Dec;40(4):325-332. doi: 10.1097/MRR.0000000000000244.

Reference Type BACKGROUND
PMID: 28723718 (View on PubMed)

McKeown J, McGeoch PD, Grieve DJ. The influence of vestibular stimulation on metabolism and body composition. Diabet Med. 2020 Jan;37(1):20-28. doi: 10.1111/dme.14166. Epub 2019 Nov 8.

Reference Type BACKGROUND
PMID: 31667892 (View on PubMed)

Fuller PM, Jones TA, Jones SM, Fuller CA. Neurovestibular modulation of circadian and homeostatic regulation: vestibulohypothalamic connection? Proc Natl Acad Sci U S A. 2002 Nov 26;99(24):15723-8. doi: 10.1073/pnas.242251499. Epub 2002 Nov 14.

Reference Type BACKGROUND
PMID: 12434016 (View on PubMed)

McGeoch PD. Can Vestibular Stimulation be Used to Treat Obesity?: Vestibular stimulation targeting the otoliths could rebalance energy homeostasis to trigger a leaner body habitus and thus treat metabolic syndrome. Bioessays. 2019 Feb;41(2):e1800197. doi: 10.1002/bies.201800197. Epub 2019 Jan 7.

Reference Type BACKGROUND
PMID: 30614540 (View on PubMed)

Fuller PM, Jones TA, Jones SM, Fuller CA. Evidence for macular gravity receptor modulation of hypothalamic, limbic and autonomic nuclei. Neuroscience. 2004;129(2):461-71. doi: 10.1016/j.neuroscience.2004.05.059.

Reference Type BACKGROUND
PMID: 15501603 (View on PubMed)

Tighilet B, Chabbert C. Adult neurogenesis promotes balance recovery after vestibular loss. Prog Neurobiol. 2019 Mar;174:28-35. doi: 10.1016/j.pneurobio.2019.01.001. Epub 2019 Jan 15.

Reference Type BACKGROUND
PMID: 30658127 (View on PubMed)

Other Identifiers

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UniterVestib

Identifier Type: -

Identifier Source: org_study_id