- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07583901
Effects of Gaze Stabalization Exercises and Optokinetic Training in Peripheral Vestibular Disorders
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Peripheral vestibular disorders (PVD) commonly cause dizziness, postural instability, and decreased balance confidence, which increase the risk of falls and limit participation in daily activities. Vestibular rehabilitation is widely used to manage these symptoms. Among rehabilitation approaches, Gaze Stabilization Exercises (GSE) aim to improve vestibulo-ocular reflex function, while Optokinetic Training (OKT) promotes symptom habituation through visual motion stimulation. However, the comparative effectiveness of these two interventions remains unclear.
This study aims to compare the effects of GSE and OKT on dizziness severity, postural stability, and balance confidence in individuals with peripheral vestibular disorders. Participants will undergo intervention sessions three times per week for six weeks. Outcome measures will be assessed at baseline, mid-intervention (week 3), and post-intervention (week 6).
Primary and secondary outcomes will include the Dizziness Handicap Inventory (DHI), Dynamic Gait Index (DGI), and the Activities-specific Balance Confidence (ABC) Scale. Data will be analyzed using SPSS statistical software. It is hypothesized that both interventions will improve dizziness, balance, and confidence, though differences in effectiveness may exist between the two approaches.
The findings of this study are expected to contribute to evidence-based vestibular rehabilitation by identifying effective intervention strategies. The results may help clinicians design personalized rehabilitation programs aimed at reducing fall risk, improving functional mobility, and enhancing quality of life in individuals with peripheral vestibular disorders.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Islamabad, Pákistán, 44000
- Foundation University College of Physical Therapy
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Male and female patients aged 35-55 years
- Complaining of dizziness for at least three months
- Reporting at least one dizziness episode per month
- Medical diagnosis of chronic peripheral vestibular disease
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Medical history or signs of central nervous system disorders and/or psychiatric disorders
- Uncontrolled hypertension and diabetes
- Incapacity to understand and follow simple verbal commands
- Inability to independently remain in standing position
- Severe visual impairment or visual impairment not compensated by corrective lenses
- Orthopedic disorders resulting in movement limitation or use of lower-limb prostheses
- Previous body balance rehabilitation in the last six months
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Gaze Stabilization Exercises
Purpose: Enhance gaze stability, postural control, and confidence in functional activities. Description: Week 1: Sitting, VOR x1 horizontal, fixate on near target - start gaze stability. Week 2: Sitting, VOR x1 vertical, near/far target - increase head speed. Week 3: Standing, VOR x1 horizontal, fixate on target - improve upright balance. Week 4: Standing, VOR x1 with busy background - challenge visual-vestibular interaction. Week 5: Standing, VOR x2 horizontal/vertical - advanced gaze stabilization. Week 6: Standing, VOR x2 with busy background - integrate dynamic visual input. |
The control group received gaze stabilization exercises for 6 weeks, comprising 18 supervised sessions conducted three times weekly.
Training included VOR x1 and VOR x2 exercises in horizontal and vertical planes using near and far visual targets.
Exercises progressed from sitting to standing positions and from simple to visually busy backgrounds.
Each session also included balance training activities such as weight shifts, tandem stance, pivot turns, and walking with head movements, with rest periods provided as needed.
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Aktivní komparátor: Optokinetic Training
Purpose: Reduce visually induced dizziness, enhance balance, and improve confidence in daily activities. Description: Week 1: Horizontal stripes Week 2: Vertical motion Week 3: Real-world videos Week 4: Crowded/busy scenes Week 5: Moving environment + light movement Week 6: Provocative videos (spirals/crowded) |
The experimental group underwent optokinetic training for 6 weeks with 18 supervised sessions conducted three times weekly.
Participants were exposed to progressively challenging moving visual stimuli, including distortion patterns, busy street scenes, motorway driving videos, and chequerboard jiggle/wrap patterns.
Training advanced from sitting to standing with dynamic movements as visual complexity increased.
Baseline and task-specific balance exercises were incorporated into every session, with adequate rest periods provided when necessary.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Dizziness
Časové okno: 6 weeks
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It will be measured by using Dizziness Handicap Inventory. Score Interpretation: 0-30: Slight or Mild Handicap 31-60: Moderate Handicap 61-100: Severe Handicap |
6 weeks
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Postural Stability
Časové okno: 6 weeks
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It will be measured by using Dynamic Gait Index (DGI). Interpretation: ≤19 = increased fall risk 20-24 = safe ambulation Higher scores = better gait performance and dynamic balance Lower scores = impaired gait and higher fall risk |
6 weeks
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Balance Confidence
Časové okno: 6 weeks
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It will be measured by using Activities-specific Balance Confidence (ABC) Scale. Interpretation: <50% = low level of physical functioning and high fall risk 50-80% = moderate level of functioning80% = high level of functioning and confidence Higher scores = greater balance confidence Lower scores = fear of falling and reduced functional independence |
6 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
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