The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases
18 de mayo de 2026 actualizado por: Şeyma Tuğba Öztürk, Medipol University
The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases: A Randomized Comparison of Cawthorne-Cooksey Exercises, 2D Visual Habituation, and 3D/Virtual Reality Visual Habituation
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Actual)
45
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34810
- Istanbul Medipol University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Cawthorne-Cooksey Exercises (CCE)
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.
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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.
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Experimental: 2D Visual Habituation
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.
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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.
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Experimental: 3D/Virtual Reality Visual Habituation
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean change in Dizziness Handicap Inventory (DHI) total score
Periodo de tiempo: Baseline and 6 weeks post-intervention
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The Dizziness Handicap Inventory (DHI) is a 25-item self-report questionnaire measuring perceived dizziness-related handicap.
Each item is scored as "Yes" (4 points), "Sometimes" (2 points), or "No" (0 points).
The total score is calculated by summing all 25 items and ranges from 0 to 100, where 0 indicates no perceived handicap and 100 indicates maximum perceived handicap.
Higher scores represent greater dizziness-related disability.
The outcome is reported as the mean change in total DHI score, calculated as post-intervention total score minus baseline total score for each participant.
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Baseline and 6 weeks post-intervention
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Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency is an objective electrophysiological measure of saccular and inferior vestibular nerve function.
Recordings were obtained using the Interacoustics Eclipse platform with 500 Hz tone-burst stimuli at 100 dB SPL delivered monaurally through insert earphones.
Surface EMG electrodes were placed over the sternocleidomastoid muscle, with the ground electrode at the vertex and reference electrode at the sternum.
The latency of the first positive peak (P13) was measured from stimulus onset to peak in milliseconds.
The outcome is reported as the mean change in P13 latency, calculated as post-intervention latency minus baseline latency for each participant.
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Baseline and 6 weeks post-intervention
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Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency is an objective electrophysiological measure of saccular and inferior vestibular nerve function.
Recordings were obtained using the Interacoustics Eclipse platform with 500 Hz tone-burst stimuli at 100 dB SPL delivered monaurally through insert earphones.
Surface EMG electrodes were placed over the sternocleidomastoid muscle.
The latency of the negative peak (N23) following the P13 peak was measured from stimulus onset to peak in milliseconds.
The outcome is reported as the mean change in N23 latency, calculated as post-intervention latency minus baseline latency for each participant.
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Baseline and 6 weeks post-intervention
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Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency is an objective electrophysiological measure of utricular and superior vestibular nerve function.
Recordings were obtained using the Interacoustics Eclipse platform with monaural acoustic stimuli delivered through insert earphones.
Surface electrodes were placed below the contralateral eye over the inferior oblique muscle, with reference electrodes 2 cm below the active electrodes and ground at the vertex.
Participants maintained an upward gaze at a fixed visual target during recording.
The latency of the first negative peak (N10) was measured from stimulus onset to peak in milliseconds.
The outcome is reported as the mean change in N10 latency, calculated as post-intervention latency minus baseline latency for each participant.
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Baseline and 6 weeks post-intervention
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Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency is an objective electrophysiological measure of utricular and superior vestibular nerve function.
Recordings were obtained using the Interacoustics Eclipse platform with monaural acoustic stimuli delivered through insert earphones.
Surface electrodes were placed over the inferior oblique muscle below the contralateral eye, with participants maintaining an upward gaze at a fixed visual target.
The latency of the positive peak (P15) following the N10 peak was measured from stimulus onset to peak in milliseconds.
The outcome is reported as the mean change in P15 latency, calculated as post-intervention latency minus baseline latency for each participant.
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Baseline and 6 weeks post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Change in cVEMP peak-to-peak amplitude from baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Baseline and 6 weeks post-intervention
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Change in oVEMP peak-to-peak amplitude from baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Baseline and 6 weeks post-intervention
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Change in cVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Baseline and 6 weeks post-intervention
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Change in oVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Periodo de tiempo: Baseline and 6 weeks post-intervention
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Baseline and 6 weeks post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Smolka W, Smolka K, Markowski J, Pilch J, Piotrowska-Seweryn A, Zwierzchowska A. The efficacy of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction. Int J Occup Med Environ Health. 2020 Apr 30;33(3):273-282. doi: 10.13075/ijomeh.1896.01330. Epub 2020 Mar 26.
- Chen PY, Hsieh WL, Wei SH, Kao CL. Interactive wiimote gaze stabilization exercise training system for patients with vestibular hypofunction. J Neuroeng Rehabil. 2012 Oct 9;9:77. doi: 10.1186/1743-0003-9-77.
- Lacour M, Helmchen C, Vidal PP. Vestibular compensation: the neuro-otologist's best friend. J Neurol. 2016 Apr;263 Suppl 1:S54-64. doi: 10.1007/s00415-015-7903-4. Epub 2016 Apr 15.
- Dutia MB. Mechanisms of vestibular compensation: recent advances. Curr Opin Otolaryngol Head Neck Surg. 2010 Oct;18(5):420-4. doi: 10.1097/MOO.0b013e32833de71f.
- Fujimoto C, Suzuki S, Kinoshita M, Egami N, Sugasawa K, Iwasaki S. Clinical features of otolith organ-specific vestibular dysfunction. Clin Neurophysiol. 2018 Jan;129(1):238-245. doi: 10.1016/j.clinph.2017.11.006. Epub 2017 Nov 21.
- Baloh RW, Kerber KA. Clinical Neurophysiology of the Vestibular System. p.480, 4th ed. Oxford: Oxford University Press, 2010
- Van De Graaff KM. Senses of hearing and balance. p.516-30. In: Human Anatomy. 6th ed. The McGraw-Hill Companies Publishing, 2001
- Dickman JD. The vestibular system. p.320-333 In: Fundamental Neuroscience for Basic and Clinical Applications. 5th ed. Elsevier Inc, 2018.
- Öndağ N. Periferik vestibüler sistem hastalıklarında uyarılmış vestibüler myojenik potansiyeller (VEMP). Gazi Üniversitesi, 2008.
- Öztürk ŞT. The Effect and Rehabilitation of Otolith Dysfunction in Vestibular Diseases [doctoral thesis]. Istanbul: Istanbul Medipol University; 2026.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2025
Finalización primaria (Actual)
24 de diciembre de 2025
Finalización del estudio (Actual)
24 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
14 de noviembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- stozturk1
- 1063 (21.12.2023) (Otro identificador: Istanbul Medipol University No)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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