- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07616596
Gaze Stabilization vs Oculomotor Exercises on Cybersickness in Computer Users (GAZE-CS)
Effectiveness of Gaze Stabilization Exercises Versus Oculomotor Exercises on Cybersickness in Computer Users: A Randomized Clinical Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a single-blinded, randomized clinical trial. Participants (n=46) will be recruited from The University of Faisalabad. Inclusion criteria include screen time >6 hours/day, computer usage for at least 10 years, and a Simulator Sickness Questionnaire (SSQ) score between 20 and 40.
Group A (Intervention): Gaze Stabilization Exercises. Week 1: View X1 exercises. Week 2: View X2 exercises. Week 3: Gaze shift exercises. Week 4: Imaginary Target exercises. (3 sessions/week, 1 minute per exercise, 3 times each).
Group B (Active Comparator): Oculomotor Exercises. Week 1: Range exercises. Week 2: Saccadic exercises. Week 3: Pursuit exercises. Week 4: Vergence exercises. (3 sessions/week, 1 minute per exercise, 3 times each).
Outcomes: The primary outcome is the change in Dynamic Visual Acuity (LogMAR scale) and Cybersickness (SSQ score). The secondary outcome is Quality of Life (SF-36 questionnaire). Measurements will be taken at baseline, Week 2, and Week 4. Data will be analyzed using SPSS version 20.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Punjab Province
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Faisalābad, Punjab Province, Paquistão, 3800
- The University of Faisalabad
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Screen time > 6 hours per day
- Computer usage history of at least 10 years
- Complaints of vertigo, blurred vision, and nausea during computer usage
- Positive Romberg's test
- Abnormal VOR (4-6 lines lost on LogMAR scale)
- SSQ score between 20 and 40
Exclusion Criteria:
- Diagnosed vestibular disorders (e.g., BPPV, Meniere's)
- History of falls in the past 6 months
- Pregnancy
- Any neurological or neurodegenerative disease
- Use of walking aids
- Severe visual impairments (worse than 6/12 on Snellen)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Gaze Stabilization Exercises
Participants in this arm will receive Gaze Stabilization Exercises (GSE) for 4 weeks, 3 sessions per week.
The protocol includes View X1, View X2, Gaze Shift, and Imaginary Target exercises.
Each exercise is performed for 1 minute, repeated 3 times per session.
Exercises target the vestibulo-ocular reflex (VOR) by coordinating head and eye movements to reduce sensory conflict.
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Week 1 - View X1: Patient sits upright.
Target held at eye level 1 meter away.
Patient turns head horizontally (left/right) or vertically (up/down) while keeping eyes fixed on target.
Speed: slow (1Hz).
Duration: 1 minute.
Repetitions: 3 times per direction.
Week 2 - View X2: Same as View X1 but head movement speed increased to 2Hz.
Week 3 - Gaze Shift: Two targets placed 30 cm apart horizontally or vertically.
Patient rotates head to face Target 1, then shifts gaze to Target 2 while continuing head rotation toward Target 2. Duration: 1 minute.
Repetitions: 3 times.
Week 4 - Imaginary Target: Patient fixates on a target (e.g., a sticker on wall).
Closes eyes.
Rotates head 30-45 degrees away from target.
While eyes closed, patient imagines still looking at target.
Opens eyes and checks if fixation is accurate.
Duration: 1 minute.
Repetitions: 3 times per direction.
All exercises are performed under supervision for the first 3 sessions, then home-based with weekly follow-up calls.
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Comparador Ativo: Oculomotor Exercises Group
Participants in this arm will receive Oculomotor Exercises for 4 weeks, 3 sessions per week.
The protocol includes Range, Saccadic, Pursuit, and Vergence exercises.
Each exercise is performed for 1 minute, repeated 3 times per session.
Exercises target isolated eye movements without head motion to improve oculomotor control and reduce visual strain.
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Week 1 - Range Oculomotor Exercises: Eyes closed.
Patient moves eyes slowly in horizontal (left-right), vertical (up-down), diagonal (top-left to bottom-right), and rotational (clockwise/counterclockwise) directions.
Duration: 1 minute per direction.
Repetitions: 3 times.
Week 2 - Saccadic Exercises: Two stationary targets (e.g., two fingers) held 30 cm apart at eye level.
Patient rapidly shifts gaze between targets without moving head.
Duration: 1 minute.
Repetitions: 3 times.
Week 3 - Pursuit Exercises: A single target (e.g., pen) is moved slowly horizontally and vertically.
Patient follows target smoothly with eyes only (head still).
Speed: approx 20 degrees/second.
Duration: 1 minute per direction.
Repetitions: 3 times.
Week 4 - Vergence Exercises: Target (e.g., pen) starts at 50 cm from patient's nose.
Patient focuses on target as it is slowly moved toward nose to 5 cm (convergence), then back to 50 cm (divergence).
Duration: 1 minute.
Repetitions: 3 times under supervision.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Vestibulo-Ocular Reflex (VOR) Function
Prazo: Baseline (Week 0), Week 2, Week 4
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Measured by Dynamic Visual Acuity (DVA) test using a LogMAR chart.
Patient reads smallest line possible while head is stationary (static VA).
Then patient rotates head horizontally at 2Hz while reading.
Number of lines lost between static and dynamic conditions is recorded.
Normal VOR: 1-2 lines lost.
Abnormal: 4-6 lines lost.
Higher lines lost = worse VOR function.
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Baseline (Week 0), Week 2, Week 4
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Change in Cybersickness Severity
Prazo: Baseline (Week 0), Week 2, Week 4
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Measured by the Simulator Sickness Questionnaire (SSQ).
Contains 16 symptoms rated 0-3 (0=not at all, 3=severe).
Total score range 0-48.
Subscales: Nausea (symptoms 1,2,6,7,8,9,14,15), Oculomotor (3,4,5,10,11,12,13), and Disorientation (5,10,11,12,13,14,15).
Higher score = worse cybersickness.
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Baseline (Week 0), Week 2, Week 4
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Quality of Life
Prazo: Baseline (Week 0), Week 4
|
Measured by the Short Form-36 (SF-36) Health Survey.
Contains 36 items measuring 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health.
Scores transformed to 0-100 scale per domain.
Higher score = better quality of life.
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Baseline (Week 0), Week 4
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TUF/EIRB/ 211 /26
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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