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The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases

18 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

45

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Turquia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turquia (Türkiye), 34810
        • Istanbul Medipol University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Comportamental: 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.
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.
Comportamental: 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.
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.
Dispositivo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean change in Dizziness Handicap Inventory (DHI) total score
Prazo: Baseline and 6 weeks post-intervention
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.
Baseline and 6 weeks post-intervention
Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency
Prazo: Baseline and 6 weeks post-intervention
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.
Baseline and 6 weeks post-intervention
Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency
Prazo: Baseline and 6 weeks post-intervention
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.
Baseline and 6 weeks post-intervention
Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency
Prazo: Baseline and 6 weeks post-intervention
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.
Baseline and 6 weeks post-intervention
Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency
Prazo: Baseline and 6 weeks post-intervention
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.
Baseline and 6 weeks post-intervention

Medidas de resultados secundários

Medida de resultado
Prazo
Change in cVEMP peak-to-peak amplitude from baseline to 6 weeks
Prazo: Baseline and 6 weeks post-intervention
Baseline and 6 weeks post-intervention
Change in oVEMP peak-to-peak amplitude from baseline to 6 weeks
Prazo: Baseline and 6 weeks post-intervention
Baseline and 6 weeks post-intervention
Change in cVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Prazo: Baseline and 6 weeks post-intervention
Baseline and 6 weeks post-intervention
Change in oVEMP interaural asymmetry ratio (IAR) from baseline to 6 weeks
Prazo: Baseline and 6 weeks post-intervention
Baseline and 6 weeks post-intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Medipol University

Colaboradores

Istanbul Medeniyet University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2025

Conclusão Primária (Real)

24 de dezembro de 2025

Conclusão do estudo (Real)

24 de março de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de novembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

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Palavras-chave

Outros números de identificação do estudo

  • stozturk1
  • 1063 (21.12.2023) (Outro identificador: Istanbul Medipol University No)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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