NCT04133025

Brief Summary

The aim of this study was to investigate of the effect of web-based System with oculomotor and optokinetic stimulation on rehabilitation in vestibular hypofunction. In the literature, studies on vestibular rehabilitation in unilateral hypofunction are very limited and there is no study about it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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 17, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

July 22, 2019

Last Update Submit

March 17, 2020

Conditions

Keywords

Vestibular RehabilitationUnilateral vestibular hypofunction

Outcome Measures

Primary Outcomes (5)

  • Change In Results of Head Thrust Test

    It tests the vestibulo-ocular reflex (VOR).The examiner holds the patient's head steady in the midline. The patient is instructed to maintain gaze on the nose of the examiner. The examiner then quickly turns the patient's head about 10-15 degrees to one side and observes the ability of the patient to keep the eyes locked on the examiner's nose. the test can also be performed by starting with the head turned to the side, and then making the quick movement back to the midline. If the patient's eyes stay locked on the examiner's nose (i.e., no corrective saccade) , then the peripheral vestibular system is assumed to be intact. Thus in a patient with acute dizziness, the absence of a corrective saccade suggests a Central Neural System(CNS) localization. If, however, the patient's eyes move with the head and then the patient makes a voluntary eye movement back to the examiner's nose (i.e., corrective saccade), then this suggests a lesion of the peripheral vestibular system and not the CNS

    Eight weeks.

  • Change In Results of Balance Tests At 8 Weeks.

    Periodic balance tests are standing on romberg, semi-tandem, tandem, one-leg positions with eyes open and closed in seconds and are recorded by timekeeper.

    Eight weeks.

  • Change In Levels of Oculomotor Functions

    Oculomotor functions are Saccade and Pursuit. They are assessed by software with normal oculomotor frequencies in Hertz.

    Eight weeks.

  • Change In Results of Head Shake Test at 8 weeks.

    The head-shaking test allows determination of an asymmetry between the two horizontal canals \[1\]. The head of the patient is shaken in the horizontal plane for 20 s and at the end of the stimulation the induced eye movements are observed. If the post head shaking nystagmus is shown, test is positive.

    Eight weeks.

  • Change In Results of Unterberger Test at 8 weeks

    The Unterberger stepping test is a simple means of identifying which labyrinth may be dysfunctional in a peripheral vertigo. The purpose of the Unterberger Test (UT) is to measure asymmetrical vestibulospinal reflex tone resulting from labyrinthine dysfunction. The UT is a low cost evaluation for dizzy patients; however, when compared with gold standard caloric irrigation unilateral weakness (UW) value ≥25%, the UT has not been shown to be a sensitive tool for identifying unilateral vestibular hypofunction

    Eight weeks.

Secondary Outcomes (2)

  • Kinesiophobia Assessment

    Before and after eight weeks treatment programmes

  • Quality of Life Assessment: Dizziness Handicap Inventory

    Before and after eight weeks treatment programmes

Study Arms (2)

Conventional vestibular rehabilitation

ACTIVE COMPARATOR

Conventional vestibular rehabilitation

Other: Vestibular Rehabilitation

Vestibular rehabilitation with software

ACTIVE COMPARATOR
Other: Vestibular Rehabilitation

Interventions

Vestibular Exercises and Software in vestibular rehabilitation

Conventional vestibular rehabilitationVestibular rehabilitation with software

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral vestibulopathy between the ages of 18-75,
  • No visual disability

You may not qualify if:

  • Mental retardation,
  • Inadequate communication in Turkish;
  • Having neurological problems,
  • Bilateral vestibular hypofunction
  • There is a serious orthopedic problem that will prevent standing and walking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Physiotherapy and Rehabilitation Doctoral Programme

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Ertunc Gulcelik G, Tarakci D, Gedik Soyuyuce O, Gence Gumus Z, Korkut N, Algun ZC. Research on the Effects of a Web-Based System With Oculomotor and Optokinetic Stimuli on Vestibular Rehabilitation. Am J Phys Med Rehabil. 2021 Jun 1;100(6):555-562. doi: 10.1097/PHM.0000000000001584.

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc PT (Specialist Physiotherapist)

Study Record Dates

First Submitted

July 22, 2019

First Posted

October 21, 2019

Study Start

January 17, 2019

Primary Completion

August 1, 2019

Study Completion

September 10, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations