NCT06004505

Brief Summary

Thirty subjects with unilateral vestibular hypofunction diagnosed by videonystagmography (VNG) were voluntarily included in the study. In addition to Static Posturography test, head thrust test, Unterberger test, bucket test, eyes open/closed tandem stance test, eyes open/closed semitandem stance test, Romberg test, one leg standing on foam floor with eyes open/closed and before vestibular rehabilitation treatment In the initial evaluations, the Visual Analogue Scale (VAS) and the Dizziness Disability Inventory (DHI) were applied to assess the severity of standing on one leg with eyes open/closed, dynamic visual acuity, vertigo, and fatigue. As a result of the study, it was concluded that vestibular rehabilitation is beneficial in patients with unilateral vestibular hypofunction and its effectiveness can be monitored with Static Posturography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

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 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 16, 2023

Last Update Submit

August 16, 2023

Conditions

Unilateral Vestibular Dysfunction Disease

Keywords

Unilateral vestibular hypofunctionbalancestatic posturographyvestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Static Posturography

    In this study, balance assessment was performed using Otometrics ICS Balance Platform Version 7.1.331 Static Posturography device. The patients were asked to take off their shoes and stand on the pressure platform, align themselves at the zero point seen on the computer screen, and stand as still as possible with their hands at their sides. Posturography, Modified Clinical Test of Sensory Interaction Balance (mCTSIB), Limits of Stability (LOS) and Balance Training included in the device are the evaluations made in the study.

    8 weeks

Secondary Outcomes (8)

  • Videonystagmography (VNG)

    8 weeks

  • Tandem Posture Test

    8 weeks

  • Semitandem Posture Test

    8 weeks

  • Romberg Test

    8 weeks

  • One Leg Standing Test

    8 weeks

  • +3 more secondary outcomes

Study Arms (1)

Vestibular Rehabilitation Group

OTHER

Vestibular rehabilitation program; Gaze consisted of stabilization, adaptation, neck and balance exercises.

Other: Vestibular Rehabilitation

Interventions

Vestibular RehabilitationOTHER

The patients received vestibular rehabilitation treatment in 4 sessions at 15-day intervals and applied the given exercise programs as home exercise in the form of 10 repetitions, 3 times a day. The exercises were performed sitting, standing and walking, respectively. Balance exercises were developed by changing the support area, support surface and arm positions. When they come to each session, the exercise programs are according to the patient's condition; alternating standing and walking forward, backward, tandem and semitandem positions.

Vestibular Rehabilitation Group

Eligibility Criteria

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

You may qualify if:

  • Individuals diagnosed with unilateral vestibular hypofunction by VNG
  • Individuals aged 18-65
  • Normal otomicroscopic examination

You may not qualify if:

  • Individuals with neurological disorders
  • Having physical problems that may interfere with walking
  • Central finding as a result of the VNG test
  • Pathology in temporal bone MRI
  • Having a cognitive impairment that prevents communication
  • Have a severe visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Güneşli Erdem Hospital

Istanbul, Bağcılar, 34200, Turkey (Türkiye)

Location

Study Officials

  • Ebru SEVER, Lecturer

    Department of Physiotherapy & Rehabilitation

    PRINCIPAL INVESTIGATOR

  • Gamze KILIÇ, PHD

    Department of Physiotherapy & Rehabilitation

    PRINCIPAL INVESTIGATOR

  • Kaan Can UYANIK, Lecturer

    Department of Health Management

    PRINCIPAL INVESTIGATOR

  • Cengiz ÇELİKYURT, Assistant Professor/MD

    Clinic of Otolaryngology

    STUDY DIRECTOR

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
master

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

January 21, 2022

Primary Completion

July 5, 2022

Study Completion

January 16, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)