Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation

NCT ID: NCT06563076

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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Vestibular Diseases Vestibular Disorder Vestibular Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vestibular Rehabilitation Group

underwent vestibular rehabilitation program

Group Type ACTIVE_COMPARATOR

Vestibular Rehabilitation

Intervention Type OTHER

supervised vestibular rehabilitation program

Vestibular Rehabilitation and Vestibular Electrical Stimulation Group

underwent vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program.

Group Type ACTIVE_COMPARATOR

Vestibular Rehabilitation

Intervention Type OTHER

supervised vestibular rehabilitation program

Vestibular Electrical Stimulation

Intervention Type OTHER

80 Hz high frequency transcutaneous vestibular electrical stimulation (VES)

Interventions

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Vestibular Rehabilitation

supervised vestibular rehabilitation program

Intervention Type OTHER

Vestibular Electrical Stimulation

80 Hz high frequency transcutaneous vestibular electrical stimulation (VES)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Bilal Burak Bayraklı

Principal Investigator, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bilal Burak Bayraklı, M.D

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Ömer Kuzu, M.D

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Canan Çelik, Professor

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Özlem Öztürk Tan, M.D

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10026336

Identifier Type: OTHER

Identifier Source: secondary_id

E2-22-2962

Identifier Type: -

Identifier Source: org_study_id

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