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Completed

NCT Number: NCT04133025

Investigation of The Effect of Web-Based System With Oculomotor and Optokinetic Stimulation on Rehabilitation in Vestibular Hypofunction

The aim of this study was to investigate of the effect of web-based System with oculomotor and optokinetic stimulation on rehabilitation in vestibular hypofunction. In the literature, studies on vestibular rehabilitation in unilateral hypofunction are very limited and there is no study about it.

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Key information

Conditions

Vestibular Rehabilitation Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases Vestibular Disease Vestibular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Physiotherapy and Rehabilitation Doctoral Programme

Istanbul, Turkey (Türkiye)

About this study

Vestibular system is one of the sensory systems used for postural control. The function of this system is to maintain balance during head movements and to sense the sense of position in the space.Information from the vestibular system goes to the neural processing center. To achieve or maintain postural control as a result of neural reorganization, balance is achieved by controlling eye movements and muscles.

Basic symptoms in vestibular pathologies are; vertigo and dizziness. Besides these; vestibulo-visual symptoms (oscillopsia, decreased visual acuity, visual tilt, etc.), postural symptoms (feeling of falling, swaying, etc.), and symptoms of motion sickness are. The occurrence of these symptoms varies according to diseases and individual characteristics.

In the treatment of vestibular diseases; there are medical treatment, vestibular rehabilitation, surgical interventions and psychosocial education.Medical treatments; it is often used to suppress or control vestibular symptoms (nausea, etc.). Surgical interventions are the last choice of treatment in patients with severe attacks such as disabling function such as labyrinthectomy or signaling the vestibular nerve. Vestibular Rehabilitation is an exercise based approach to maximize central nervous system compensation for vestibular pathology.

In recent years, the effectiveness of the technologies that have been used in different areas of rehabilitation in vestibular rehabilitation has started to be investigated. In the researches, it is seen that virtual reality is one of the most used technologies. In terms of virtual reality usage, it has cost, size and portability advantages (3). However, in other studies, different systems apart from virtual reality are almost not found among the assistive technologies in vestibular rehabilitation.

In recent years, vestibular rehabilitation methods, adaptation to changing sensory conditions and sensory repetition methods in compensation process have been emphasized to increase adaptation to vestibular losses. However, individual therapeutic programs need to be planned in accordance with clinical symptoms. To this end, there is a need to develop reliable objective and technological feedback techniques to measure the interaction of peripheral senses and central adjustment mechanisms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral vestibulopathy between the ages of 18-75,
  • No visual disability

Exclusion criteria

  • Mental retardation,
  • Inadequate communication in Turkish;
  • Having neurological problems,
  • Bilateral vestibular hypofunction
  • There is a serious orthopedic problem that will prevent standing and walking.

Treatment and study plan

Vestibular Rehabilitation

Other

Vestibular Exercises and Software in vestibular rehabilitation

Primary outcomes

  1. Change In Results of Head Thrust Test

    Time frame: Eight weeks.

    It tests the vestibulo-ocular reflex (VOR).The examiner holds the patient's head steady in the midline. The patient is instructed to maintain gaze on the nose of the examiner. The examiner then quickly turns the patient's head about 10-15 degrees to one side and observes the ability of the patient to keep the eyes locked on the examiner's nose. the test can also be performed by starting with the head turned to the side, and then making the quick movement back to the midline. If the patient's eyes stay locked on the examiner's nose (i.e., no corrective saccade) , then the peripheral vestibular system is assumed to be intact. Thus in a patient with acute dizziness, the absence of a corrective saccade suggests a Central Neural System(CNS) localization. If, however, the patient's eyes move with the head and then the patient makes a voluntary eye movement back to the examiner's nose (i.e., corrective saccade), then this suggests a lesion of the peripheral vestibular system and not the CNS

  2. Change In Results of Balance Tests At 8 Weeks.

    Time frame: Eight weeks.

    Periodic balance tests are standing on romberg, semi-tandem, tandem, one-leg positions with eyes open and closed in seconds and are recorded by timekeeper.

  3. Change In Levels of Oculomotor Functions

    Time frame: Eight weeks.

    Oculomotor functions are Saccade and Pursuit. They are assessed by software with normal oculomotor frequencies in Hertz.

  4. Change In Results of Head Shake Test at 8 weeks.

    Time frame: Eight weeks.

    The head-shaking test allows determination of an asymmetry between the two horizontal canals [1]. The head of the patient is shaken in the horizontal plane for 20 s and at the end of the stimulation the induced eye movements are observed. If the post head shaking nystagmus is shown, test is positive.

  5. Change In Results of Unterberger Test at 8 weeks

    Time frame: Eight weeks.

    The Unterberger stepping test is a simple means of identifying which labyrinth may be dysfunctional in a peripheral vertigo. The purpose of the Unterberger Test (UT) is to measure asymmetrical vestibulospinal reflex tone resulting from labyrinthine dysfunction. The UT is a low cost evaluation for dizzy patients; however, when compared with gold standard caloric irrigation unilateral weakness (UW) value ≥25%, the UT has not been shown to be a sensitive tool for identifying unilateral vestibular hypofunction

Secondary outcomes

  1. Kinesiophobia Assessment

    Time frame: Before and after eight weeks treatment programmes

    Tampa Kinesiophobia Scale (TKS) is used. It is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.

  2. Quality of Life Assessment: Dizziness Handicap Inventory

    Time frame: Before and after eight weeks treatment programmes

    Dizziness Handicap Inventory is used. The purpose of this scale is to identify difficulties that you may be experiencing because of your dizziness.Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2019
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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