Clinical trial NCT05231109: Effect of Vestibular Rehabilitation in Patients With Bilateral Vestibular Hypofunction
Official title: The Effect of Vestibular Rehabilitation on Balance and Quality of Life in Patients With Bilateral Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuals With Vestibular Hypofunction
Individuals Between the Ages of 18-65
Keywords: Bilateral vestibular hypofunction
Quality of life
Balance
Vestibular rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bilateral vestibular function is a heterogeneous chronic condition characterized by bilaterally decreased or absent function of vestibular organs, vestibular nerves, or both.1 Patients present with various symptoms such as oscillopsia, imbalance, visual vertigo, cognitive deficits, autonomic symptoms, and impaired spatial orientation. The aim of this study is to investigate the effectiveness of vestibular rehabilitation on balance, dynamic visual acuity and quality of life in patients with bilateral vestibular hypofunction. Twenty patients diagnosed with bilateral vestibular hypofunction by videonystagmography were included in the study. Balance Tests, Visual Analogue Scale, Dynamic Visual Acuity, Dizziness Disability Inventory for quality of life, computer modified for Sensory Interaction in Balance Clinical Test (MCTSIB) tests and Limits of Stability test, which provides evaluation of body movements, which are an important part of balance, in all directions. Evaluations were made at 3 and 6 months before treatment. Physiotherapy sessions were given at two-week intervals. According to the development of the patients, they were asked to perform a home exercise program with 10 repetitions 3 times a day.

Detailed description: After the initial evaluations, the patients included in the study were included in the rehabilitation program. The rehabilitation program consisted of two phases. The first phase included patient education. All patients were planned to receive a verbal training for 30 minutes by the physiotherapist, including the definition of unilateral vestibular hypofunction, its importance, risk factors, ways of prevention, and recommendations for preventing falls. The second phase consisted of the vestibular exercise program. In this phase, vestibular adaptation exercises, oculo-motor exercises, standing by changing the support area, the support surface and the arm positions, heel-toe walking, walking with head rotation, backward walking, counting on a soft surface with eyes open and closed, and dynamic balance exercises were taught to the patients. The exercise program was arranged 3 times a day for 6 months, and each exercise was 10 repetitions. The patients were called for physiotherapist control once every 2 weeks. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month.

Eligibility criteria: Inclusion Criteria:

1. To be diagnosed with bilateral vestibular hypofunction by Videonystagmography test
2. To be between the ages of 18-75
3. To have communication and cooperation skills
4. To have no problems originating from the central nervous system
5. To have previously had ear infections, not having undergone surgery

Exclusion Criteria:

1. Having cognitive dysfunction
2. Presence of temporal bone pathologies detected by magnetic resonance imaging
3. Presence of other inner ear disorders that may cause dizziness and imbalance as determined by audiogram, tympanogram, and acoustic reflexes
4. Previous lower extremity injuries
5. The presence of central findings in Videonystagmography results

Primary outcomes:
measure: Change from Baseline Static Posture Evaluation at 6 Months (Limits of Stability and modified for Sensory Interaction in Balance Clinical Test )
timeFrame: 6 months
measure: Change from Baseline Dizziness Handicap Inventory at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Results of Dynamic Visual Acuity, Subjective Visual
timeFrame: 6 months
measure: Results of Dizziness Severity Scale, Subjective Visual
timeFrame: 6 month
measure: Results of Tandem, Semi-tandem, Romberg and One-Leg Stance Test, Subjective Visual
timeFrame: 6 months
Other outcomes:
Locations:
city: Bağcılar
country: Turkey
facility: Bağcılar Safa Hastanesi
state: Yıldıztepe
Study officials:
affiliation: PhD student
name: Gamze Kılıç, master
role: PRINCIPAL_INVESTIGATOR
affiliation: head of physical medicine and rehabilitaton department
name: Z. Candan Algun, professor
role: STUDY_DIRECTOR
References: