NCT05676307

Brief Summary

The purpose of this study is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients. The Caloric test and Video Head Impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to Clinic with complaints of vertigo, dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. In order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was done with timed balance tests and quality of life assessment was performed with Dizziness Handicap Inventory.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
Last Updated

January 9, 2023

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

December 2, 2022

Last Update Submit

December 22, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Evaluation of Oculomotor Activity (Saccade Frequency Level)

    Oculomotor Function Level was evaluated with Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System. The name of this web-based system that supports VOR wient in the evaluation part of the vestibular software.sth oculomotor and optokinetic stimuli is Simulation of Vestibulo-Ocular Reflex Exercises (SVORE). This system includes Assessment and Rehabilitation departments. The maximum saccade frequency levels were determined with the measurements. For the evaluation of saccade eye movement, patient will be asked to focus on the objects on the screen.

    8 week

  • Quality of Life Assesment

    The level of quality of life was evaluated with Dizziness Handicap inventory.The Dizziness Handicap Inventory (DHI), which evaluates the quality of life in vestibular diseases, was used in the study. This 25-item scale determines the emotional and functional outcomes of patients in vestibular system diseases as well as aggravating factors related to dizziness and impaired balance.

    8 weeks

  • Static Balance Tests

    To evaluate the static balance of the patients; Length of standing in romberg, semitandem, tandem, standing on one leg, eyes open-closed positions were recorded in seconds with a stopwatch.

    8 weeks

  • Evaluation of Oculomotor Activity (Pursuit Frequency Level)

    Oculomotor Function Level was evaluated with Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System. The name of this web-based system that supports VOR wient in the evaluation part of the vestibular software.sth oculomotor and optokinetic stimuli is Simulation of Vestibulo-Ocular Reflex Exercises (SVORE). This system includes Assessment and Rehabilitation departments. The maximum pursuit frequency levels were determined with the measurements.For the evaluation of pursuit eye movement, patient will be asked to focus continuely on the objects on the screen.

    8 weeks

Study Arms (1)

Bilateral Vestibular Hypofunction

EXPERIMENTAL

Vestibular Rehabilitation in Bilateral Vestibular Hypofunction

Behavioral: Vestibular Rehabilitation

Interventions

Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc)

Bilateral Vestibular Hypofunction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18-70 years of age with bilateral vestibular hypofunction and peripheral vestibulopathy

You may not qualify if:

  • Patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gönül Ertunç Gülçelik

Kocaeli, 41030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bilateral Vestibulopathy

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 2, 2022

First Posted

January 9, 2023

Study Start

January 15, 2022

Primary Completion

October 23, 2022

Study Completion

November 12, 2022

Last Updated

January 9, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations