Effects of Structured Exercise Program in Bilateral Vestibular Hypofunction

NCT ID: NCT05853562

Last Updated: 2023-05-10

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-05-31

Brief Summary

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Background: The vestibular rehabilitation is an exercise-based method, aiming to maximize central nervous system(CNS) compensation at vestibular nuclear and other CNS levels for vestibular pathology. A minimal number of studies have documented the impact of Vestibular rehabilitation on the recovery rate of patients with Bilateral Vestibular Hypofunction(BVH).

Objective: The purpose of this study was to investigate the effectiveness of structured vestibular rehabilitation (VR) programs on severity of dizziness, kinesiophobia, balance, fatigue, quality of sleep, activities of daily living( ADL) and quality of life(QoL) in subjects with chronic BVH.

Method: Twenty-five participants diagnosed with BVH were included in the study. A structured VR program was applied in 50-minute sessions once a week and as a home exercise program 3 days a week over 8 weeks. Participants were evaluated for severity of dizziness with the Visual Analog Scale (VAS), for kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), for balance with the Semitandem, tandem, and standing tests, for quality of sleep with the Pittsburgh Sleep Quality Index (PSQI), for ADL with the Vestibular Disorders Activities of Daily Life (VADL), for QoL with Dizziness Handicap Inventory (DHI) and for fatigue with the Fatigue Severity Scale (FSS) at the baseline (T0), at 4th week (T1), 8th week (T2), and 20th week (T3) after study started.

Detailed Description

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Conditions

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Bilateral Vestibular Hypofunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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T0-T1 period

It was a control period. Participants were asked to continue their routine activities for 4 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

T1-T2 period (structured vestibular rehabilitation program)

A structured vestibular rehabilitation program was applied in 50-minute sessions under the supervision of a physiotherapist once a week and as a home exercise program 3 days a week over 4 weeks.

Group Type EXPERIMENTAL

structured vestibular rehabilitation program

Intervention Type OTHER

The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.

T2-T3 period

A structured vestibular rehabilitation program was applied in 50-minute sessions under the supervision of a physiotherapist once a week and as a home exercise program 3 days a week over 4 weeks. Afterwards, participants participated in the home program with telerehabilitation for 8 weeks.

Group Type ACTIVE_COMPARATOR

structured vestibular rehabilitation program

Intervention Type OTHER

The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.

Interventions

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structured vestibular rehabilitation program

The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between 20-80 years old
* Diagnosed with bilateral peripheral vestibular hypofunction by videonystagmography
* Have symptoms for more than three months from onset of illness

Exclusion Criteria

* having no symptoms of bilateral peripheral vestibular hypofunction
* having Meniere's disease, vestibular migraine and other undulating vestibular disorders, cognitive, visual, neurological or general motor impairment
* having previously received vestibular rehabilitation
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Miray Budak

OTHER

Sponsor Role lead

Responsible Party

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Miray Budak

Asst Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BVH_Structured_Exercise

Identifier Type: -

Identifier Source: org_study_id

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