The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases
NCT07606196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-05-26
Summary
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.
Conditions
- Vestibular Hypofunction
- Vestibular Assessment
- Vestibular Exercises
- Vestibulopathy
- Rehabilitation
- Unilateral Vestibular Deficit
Interventions
- BEHAVIORAL
-
Cawthorne-Cooksey Exercises
A classical vestibular rehabilitation protocol promoting central vestibular compensation through habituation and adaptation mechanisms. The 6-week protocol consists of hierarchical eye, head, and body movements progressing across three phases: Weeks 1-2 in sitting position (saccade and VOR exercises, single-leg standing, head shaking with eyes closed); Weeks 3-4 in standing position (saccades and VOR while standing, walking on mat, sit-to-stand exercises); Weeks 5-6 dynamic phase (saccades and VOR while walking, walking with head shaking, single-leg standing on soft surface). Exercises were performed three times daily (morning, noon, evening). Progression was individualized based on symptom provocation. Patients received initial in-clinic training and were followed remotely via the Moodle e-learning platform with weekly video-based exercise modules.
- BEHAVIORAL
-
2D Visual Habituation
A digital visual habituation protocol targeting otolith organs through wide-field 2D optokinetic visual flow stimuli. Pre-recorded videos generating horizontal-plane and vertical-plane motion perception (vection) were used to promote otolith re-weighting and habituation. Participants viewed videos seated in front of a screen at eye level, 1 meter away. Each session lasted 15-20 minutes and was performed three times daily (morning, noon, evening) for 6 weeks. Both horizontal and vertical optokinetic stimuli were delivered per session. Stimulus duration, speed, and complexity were gradually increased according to individual symptom tolerance. Sessions were paused if marked nausea or severe dizziness developed. Patients accessed videos through dedicated Moodle e-learning platform modules via smartphone or computer, ensuring standardized delivery and adherence monitoring.
- DEVICE
-
3D/Virtual Reality Visual Habituation
An immersive virtual reality (VR) visual habituation protocol targeting otolith organs through 3D wide-field optokinetic stimuli. The horizontal- and vertical-plane motion stimuli used in the 2D protocol were adapted for VR delivery using Movavi Video Editor 360 software and presented via a head-mounted display (VR Shinecon G04ea, Scinecon, China). Participants were immersed in 3D visual flow scenarios generating motion perception (vection), providing a more naturalistic stimulus than screen-based delivery. Sessions lasted 15-20 minutes and were performed three times daily for 6 weeks. Stimulus intensity and complexity were progressively increased according to tolerance. Short breaks were provided to minimize cybersickness. The Moodle platform supported protocol delivery and remote adherence monitoring. The protocol targeted otolith-related symptoms through systematic desensitization and sensory re-weighting.
Sponsors & Collaborators
-
Istanbul Medeniyet University
collaborator OTHER -
Medipol University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2025-12-24
- Completion
- 2026-03-24
Countries
- Turkey (Türkiye)
Study Locations
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