- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Vestibulo-Ocular Reflex (VOR) Function
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Quality of Life
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TUF/EIRB/ 211 /26
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