NCT05070936

Brief Summary

Vestibular hypofunction is a disease which emerge through a partial or total loss on a vestibular organ or vestibular nerve. It can be seen unilateral or bilateral. Aim of the study is to examine effects of vestibular rehabilitation on kinesiophobia, quality of life, dynamic vision acuity and balance. The study was conducted with patients diagnosed with vestibular hypofunction. 30 patients who are in the ages between 18 and 65 have participated in the study. Exercise programs has given to patients to do at home. Patients were observed every two weeks in the hospital. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Before and after the treatment, Tampa Kinesiophobia Scale, World Health Organization Quality of Life Scale-Short form in Turkish, Dynamic Visual Acuity Test, Balance Tests, Unterberger Test, Visual Analog Scale to measure dizziness and fatigue, for verticality and horizontality perception Subjective Visual Vertical and Subjective Visual Horizontal tests have been applied. As a result of the study, statistical correlations have been found except semi-tandem posture test with eyes open and Romberg's test both with eyes open and closed. It can be said that vestibular rehabilitation has improved quality of life, balance, dynamic vision acuity and overcame kinesiophobia on the patients.

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 Feb 2020

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

February 14, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

October 6, 2021

Last Update Submit

September 16, 2024

Conditions

Keywords

BalanceDynamic visual acuityKinesiophobiaVestibular hypofunctionVestibular rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Before and After Tampa Kinesiophobia Scale Values

    It was determined that there was a statistically significant difference between the before and after measurement values of the Tampa kinesiophobia scale dimensions.

    8 Weeks

Secondary Outcomes (2)

  • World Health Organization Quality of Life Scale-Short form Before and After Values

    8 Weeks

  • : Results of Tandem Stance Test, Subjective Visual Vertical and Subjective Visual Horizontal Tests, Dizziness Severity and Dynamic Visual Acuity Parameters

    8 Weeks

Study Arms (1)

vestibular rehabilitation group

OTHER

Vestibular rehabilitation was performed. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Patients were observed in the hospital every two weeks. The exercises given in the session were given as home exercises, 3 times a day, for 10 repetitions.

Other: vestibular rehabilitation

Interventions

Vestibular rehabilitation consisted of a total of 4 sessions, rearranged every 15 days. These exercises were prepared gradually to increase the vestibulo-ocular reflex and vestibulospinal reflex. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. The therapist gave the patients a home exercise program. It was emphasized that the exercises should be applied as 10 repetitions. After the session, the exercises shown to the patients were explained in written form and given as home exercises. They were also asked to do home exercises 3 times a day, 10 repetitions, for 15 days. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients.

vestibular rehabilitation group

Eligibility Criteria

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

You may qualify if:

  • Individuals with vestibular hypofunction diagnosed by videonystagmography test
  • Patients aged between 18-65 years.

You may not qualify if:

  • Patients with visual impairment and neurological involvement
  • Individuals with wavy vertigo
  • Ataxia, or other lesions causing oscillopsia
  • Dementia
  • Patients with severely limited mobility and unable to walk without using a walker, cane, or orthosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Güneşli Erdem Hastanesi

Bağcılar, Güneşli, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Ebru Sever, master

    master student

    PRINCIPAL INVESTIGATOR
  • Z.Candan Algun, professor

    head of physical medicine and rehabilitation department

    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
Specialist Physiotherapist

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 7, 2021

Study Start

February 14, 2020

Primary Completion

September 14, 2020

Study Completion

April 2, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations