The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases

Medipol University

Status: Completed

Conditions: Vestibular Hypofunction; Rehabilitation; Unilateral Vestibular Deficit; Vestibular Assessment; Vestibulopathy; Vestibular Exercises

Treatments: Device: 3D/Virtual Reality Visual Habituation; Behavioral: 2D Visual Habituation; Behavioral: Cawthorne-Cooksey Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07606196

stozturk1

1063 (21.12.2023) (Other Identifier)

Details and patient eligibility

About

This randomized controlled study compared the clinical and electrophysiological effectiveness of three vestibular rehabilitation approaches in patients with unilateral peripheral vestibular disease accompanied by otolith dysfunction: (1) traditional Cawthorne-Cooksey exercises (CCE), (2) two-dimensional (2D) otolith-targeted visual habituation, and (3) three-dimensional/virtual reality (3D/VR) otolith-targeted visual habituation. Forty-five patients aged 18-60 years were randomized into three groups and followed for 6 weeks. The Dizziness Handicap Inventory (DHI) was used as the primary clinical outcome, and cervical and ocular Vestibular Evoked Myogenic Potentials (cVEMP and oVEMP) were used as objective electrophysiological measures. Patients were monitored remotely using the Moodle learning management system.

Full description

Vestibular rehabilitation is a cornerstone of management in peripheral vestibular hypofunction. While conventional protocols such as the Cawthorne-Cooksey exercises focus largely on vestibulo-ocular reflex adaptation, otolith organs (utricle and saccule) are often underaddressed despite their critical role in spatial orientation and postural stability. Visual habituation protocols delivering wide-field optokinetic stimuli in the horizontal and vertical planes may target otolith-related symptoms more directly.

In this trial, 45 patients with chronic unilateral peripheral vestibular hypofunction (>3 months post-attack) and VEMP asymmetry >40% were randomized into three groups: CCE (n=16), 2D visual habituation (n=13), and 3D/VR visual habituation (n=16). Each group performed assigned exercises three times daily for 6 weeks, supported by the Moodle e-learning platform. Outcomes were assessed pre- and post-intervention using DHI and cVEMP/oVEMP latency, amplitude, and interaural asymmetry ratio (IAR).

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosed unilateral peripheral vestibular disease No identified hearing loss (symmetric hearing) VEMP interaural asymmetry >40% At least 3 months post-acute attack (chronic phase) No ocular disorders No cervical/physical problems No history of psychological or neurological disorders No regular use of alcohol or vestibular suppressant medications Non-fluctuating vestibular symptoms

Exclusion criteria

Additional balance disorder pathology beyond unilateral peripheral vestibular disease BPPV repositioning maneuver within the last 30 days Asymmetric or moderate-to-severe hearing loss Motion sickness Active BPPV symptoms in history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Cawthorne-Cooksey Exercises (CCE)

Active Comparator group

Description:

Traditional vestibular rehabilitation protocol consisting of progressive eye, head, and body movements (saccade and VOR exercises, balance exercises) performed three times daily for 6 weeks, with hierarchical difficulty progression across weeks 1-2, 3-4, and 5-6.

Treatment:

Behavioral: Cawthorne-Cooksey Exercises

2D Visual Habituation

Experimental group

Description:

Otolith-targeted visual habituation using 2D wide-field optokinetic flow videos in horizontal and vertical planes. Patients viewed videos on a screen positioned at eye level at 1 meter distance, three times daily (morning/noon/evening), approximately 15-20 minutes per session, for 6 weeks.

Treatment:

Behavioral: 2D Visual Habituation

3D/Virtual Reality Visual Habituation

Experimental group

Description:

Otolith-targeted visual habituation delivered via VR headset (VR Shinecon G04ea) presenting 3D wide-field optokinetic flow in horizontal and vertical planes. Same dosing as 2D arm: three times daily, 15-20 minutes per session, for 6 weeks.

Treatment:

Device: 3D/Virtual Reality Visual Habituation