- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Faisalābad, Punjab Province, Pákistán, 3800
- The University of Faisalabad
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Vestibulo-Ocular Reflex (VOR) Function
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Quality of Life
Časové okno: Baseline (Week 0), Week 4
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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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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