NCT04842474

Brief Summary

Gaze stability exercise is a medical procedure for persons with unilateral vestibular disturbances such as vestibular neuritis or persons who have had tumors of their 8th nerve. They are a crucial part of the vestibular dysfunction rehabilitation protocols in health centers. These activities which involve turning one's eyes at different angles while having their eyes focused on an optotype are aimed at helping improve the vestibular ocular reflex (VOR), visual acuity during head movements and also reducing vertigo and dizziness. Study aim: This review will be establishing the effectiveness of applying gaze stability with balance exercises procedure among participants who are suffering vertigo due to vestibular neuritis. Methods: Twenty volunteers between the age of 25-59 years old, diagnosed, and confirmed to be suffering from vestibular neuritis and vertigo will be used in this study. Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes. The following outcome measures for each participant will be assessed pre-and post-treatment after completing four weeks of intervention. They include; Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale), Arabic version of Dizziness Handicap Inventory (A-DHI), Berg Balance Scale (BBS), and Katz Index of Independence in Activities of Daily Living (Katz ADL). The findings will then be subjected to statistical methods and data analysis using the SPSS toolkit. In this study we hypothesis that practicing gaze stability and balance exercises will have a positive influence on balance and activities of daily living among vestibular neuritis patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

February 7, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 2, 2021

Last Update Submit

April 12, 2021

Conditions

Keywords

vertigovestibular neuritisgaze stability exercisebalance exercisevestibular rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale)

    measure patient self-confidence for doing activities without losing balance. Minimum 0%, maximum 100%, lower value means lower self confidence to do activity without loose balance

    Change from baseline A-ABC at 4 weeks

  • Arabic version of the Dizziness handicap inventory questionnaire (A-DHI)

    To assess the impact of dizziness on activities, It is ordinal scale including Yes, sometimes, No answers.

    Change from baseline A-DHI at 4 weeks

  • Berg Balance Scale (BBS)

    to evaluate static balance and fall risk in adult. minimum 0, maximum 56, lower score means less balance and higher score indicates better balance.

    Change from baseline BBS at 4 weeks

  • Katz Index of Independence in Activities of Daily Living (Katz ADL)

    to define problems in performing ADLs. minimum 0 patient is dependent, maximum 6 patient is independent.

    Change from baseline Katz ADL at 4 weeks

Study Arms (1)

Gaze stability and balance exercises

EXPERIMENTAL

Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes.

Other: Gaze stability exercises and balance exercises

Interventions

Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes.

Gaze stability and balance exercises

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A convenience volunteers of adults of 25-59 years old are diagnosed with vestibular neuritis and vertigo.
  • Participants should not be either with a previous history of neurological diseases or brain surgery affecting equilibrium.
  • Both male and female are cognitively intact.
  • Subjects with medical issues, e.g., hypertension and diabetes, are undertaking medication regularly.
  • Independent participants or those requiring reasonable assistance, but with balance disturbance in daily living activities and transferring.
  • Having Berg Balance Scale between 21-56 are included in the study.

You may not qualify if:

  • Subjects with the inability to follow instructions or completely dependent on the assistive device during mobility.
  • Participants with chronic dizziness diagnosed specifically with benign paroxysmal positional vertigo (BPPV), or Meniere's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

VertigoMigraine DisordersVestibular Neuronitis

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesVestibulocochlear Nerve DiseasesRetrocochlear DiseasesCranial Nerve Diseases

Study Officials

  • Maha M Almarwani, PHD

    King Saud University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Gaze stability exercises are included in five phases: eyeball movement, saccadic eye movement, pursuit eye movement, vengeance eye movement, and vestibular-ocular reflex exercise. Gaze stability exercises will be performed while patients are seated, and each exercise lasts for 30 seconds. Balance exercises, both static and dynamic with or without closing eyes, are recommended to improve postural stability. In the first two weeks, patients will perform balance exercises with opening eyes, and then in the next couple of weeks, participants will do the same exercises with closing eyes. It involves standing on a firm surface with feet apart, heel stand, toe stand, marching on a firm surface, semi tandem stand, walking forward and backward with a normal support base. It will be applied twice each alternative day with ten repetitions for a total treatment period of four weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

April 2, 2021

First Posted

April 13, 2021

Study Start

February 7, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations