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Clinical Trials/NCT06563076
NCT06563076
Completed
N/A

Evaluation of the Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation

Ankara City Hospital Bilkent1 site in 1 country38 target enrollmentJanuary 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vestibular Diseases
Sponsor
Ankara City Hospital Bilkent
Enrollment
38
Locations
1
Primary Endpoint
Dizziness Handicap Inventory
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aimed to evaluate the effectiveness of the vestibular rehabilitation program applied to patients with chronic unilateral vestibular hypofunction and the vestibular electrical stimulation applied to the trapezius muscles and cervical paravertebral muscles along with the rehabilitation program.

Detailed Description

This study included 40 patients with unilateral vestibular hypofunction findings, aged between 18 and 65, and whose unilateral vestibulo-ocular reflex (VOR) gain for any semicircular canal was below 0.7 based on the video head impulse test (vHIT) test, were randomized into two groups. While one group underwent a supervised vestibular rehabilitation program for 4 weeks, the other group received 80 Hz high frequency transcutaneous vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program. The treatment was applied to each group, 3 days a week, for a total of 12 sessions. Detailed musculoskeletal system examinations and vestibular system examinations of the included patients were performed, and sociodemographic characteristics (age, gender, body mass index (BMI), education level) were recorded. Both groups were tested before treatment and at the end of the 4th week, Dizziness Disability Inventory (DHI), Visual Analogue Scale (VAS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Activity-Specific Balance and Confidence Scale (ABCs), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and Static Posturography.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bilal Burak Bayraklı

Principal Investigator, Medical Doctor

Ankara City Hospital Bilkent

Eligibility Criteria

Inclusion Criteria

  • Being between the ages of 18-65
  • Patients who were evaluated by a Neurologist, Physical Medicine and Rehabilitation Specialist and otorhinolaryngologist and diagnosed with chronic unilateral vestibular hypofunction and have findings of chronic unilateral vestibular hypofunction
  • Patients whose VOR gain for any unilateral semicircular canal based on vHIT test is below 0.7
  • Patients who volunteered to participate in the study and signed the consent forms

Exclusion Criteria

  • Existing neurological or mental disorders
  • Patients using vestibulosuppressant drugs
  • Stroke, head trauma and other neurological diseases
  • Patients with a history of brain surgery
  • Patients with severely limited neck joint range of motion (those with a limitation of 45 degrees or more)

Outcomes

Primary Outcomes

Dizziness Handicap Inventory

Time Frame: Baseline and after 4 weeks

'Dizziness Handicap Inventory (DHI)' consists of 25 items that determine the functional and sensory consequences of vestibular system diseases as well as the factors that aggravate dizziness and balance disorders. Questions 1, 4, 8, 11, 13, 17 and 25 of the scale are structured to measure physical disability; questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 are structured to measure emotional disability; questions 3, 5, 6, 7, 12, 14, 16, 19 and 24 are structured to measure functional disability. Each question is scored as yes (4 points), no (0 points) and sometimes (2 points). The level of disability can be categorized according to the scale: 16-34 points = mild disability; 36-52 points = moderate disability; 54+ points = severe disability

Secondary Outcomes

  • Beck Depression Inventory(Baseline and after 4 weeks)
  • Beck Anxiety Inventory(Baseline and after 4 weeks)
  • Timed Up and Go Test(Baseline and after 4 weeks)
  • Berg Balance Score(Baseline and after 4 weeks)
  • Dizziness Severity Visual Analog Scale(Baseline and after 4 weeks)
  • Activity Specific Balance and Confidence Scale(Baseline and after 4 weeks)
  • Static Posturography(Baseline and after 4 weeks)

Study Sites (1)

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