Effect of Vestibular Rehabilitation in Patients With Bilateral Vestibular Hypofunction

NCT05231109 | Completed

• 1 other identifier: 10840098-604.01.01-E.53654
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Individuals With Vestibular Hypofunction; Individuals Between the Ages of 18-65

Keywords

Bilateral vestibular hypofunction; Quality of life; Balance; Vestibular rehabilitation

Outcome Measures

Primary Outcomes (2)

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

  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.

  6 months

• Change from Baseline Dizziness Handicap Inventory at 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.

  6 months

Secondary Outcomes (3)

• 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 Arms (1)

vestibular rehabilitation group

OTHER

Vestibular rehabilitation was performed. The following exercises were done with the patients: 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.

Other: vestibular rehabilitation

Interventions

vestibular rehabilitation OTHER

Vestibular rehabilitation consisted of a total of 12 sessions, rearranged every 15 days. These exercises were prepared gradually to increase the vestibulo-ocular reflex and vestibulospinal reflex. The following exercises were done with the patients: 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 therapist gave the patients a home exercise program. It was emphasized that the exercises should be applied as 10 repetitions. After the session, the exercises shown to the patients were explained in written form and given as home exercises. They were also asked to do home exercises 3 times a day, 10 repetitions, for 15 days. Patients were re-evaluated before the treatment, at the 3rd month and after the 6th month.

vestibular rehabilitation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Bağcılar Safa Hastanesi

Bağcılar, Yıldıztepe, 34203, Turkey (Türkiye)

Location

Study Officials

• Gamze Kılıç, master

  PhD student

  PRINCIPAL INVESTIGATOR

• Z. Candan Algun, professor

  head of physical medicine and rehabilitaton department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 9, 2022
• Study Start: December 21, 2018
• Primary Completion: January 3, 2019
• Study Completion: September 24, 2019
• Last Updated: February 9, 2022

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)