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Clinical Trials/NCT05231109
NCT05231109
Completed
N/A

The Effect of Vestibular Rehabilitation on Balance and Quality of Life in Patients With Bilateral Vestibular Hypofunction

Istanbul Medipol University Hospital1 site in 1 country20 target enrollmentDecember 21, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Individuals With Vestibular Hypofunction
Sponsor
Istanbul Medipol University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Change from Baseline Static Posture Evaluation at 6 Months (Limits of Stability and modified for Sensory Interaction in Balance Clinical Test )
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2018
End Date
September 24, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change from Baseline Static Posture Evaluation at 6 Months (Limits of Stability and modified for Sensory Interaction in Balance Clinical Test )

Time Frame: 6 months

With the limits of stability program on the balance device called Otometrics ICS Balance Platform, the body's final reaching points, the speed of movement, and direct control were evaluated, in 8 directions. Within this device, the modified for Sensory Interaction in Balance Clinical Test test was evaluated by showing areas of oscillation. Modified-CTSIB is a clinical test that is generally used as a semi-quantitative test measurement, and is scored according to the person's ability to perform various standing static positions.Before removing the patient on the device, the center of gravity is determined by entering the height and weight, and the patient visually sees the center of gravity when he/she gets on the balance platform. Then all tests are done according to this center of gravity.

Change from Baseline Dizziness Handicap Inventory at 6 Months

Time Frame: 6 months

Dizziness Handicap Inventory was used to evaluate the quality of life of patients. This scale consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases.

Secondary Outcomes

  • Results of Dynamic Visual Acuity, Subjective Visual(6 months)
  • Results of Dizziness Severity Scale, Subjective Visual(6 month)
  • Results of Tandem, Semi-tandem, Romberg and One-Leg Stance Test, Subjective Visual(6 months)

Study Sites (1)

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