Clinical trial NCT06563076: Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation
Official title: Evaluation of the Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Vestibular Disorder
Vestibular Vertigo
Keywords: Vertigo
Rehabilitation
TENS
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Dizziness Severity Visual Analog Scale
timeFrame: Baseline and after 4 weeks
measure: Timed Up and Go Test
timeFrame: Baseline and after 4 weeks
measure: Berg Balance Score
timeFrame: Baseline and after 4 weeks
measure: Activity Specific Balance and Confidence Scale
timeFrame: Baseline and after 4 weeks
measure: Beck Depression Inventory
timeFrame: Baseline and after 4 weeks
measure: Beck Anxiety Inventory
timeFrame: Baseline and after 4 weeks
measure: Static Posturography
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Bilal Burak Bayraklı, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: Ömer Kuzu, M.D
role: STUDY_CHAIR
affiliation: Ankara City Hospital Bilkent
name: Canan Çelik, Professor
role: STUDY_DIRECTOR
affiliation: Ankara City Hospital Bilkent
name: Özlem Öztürk Tan, M.D
role: STUDY_CHAIR
References: