- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07583901
Effects of Gaze Stabilization Exercises and Optokinetic Training in Peripheral Vestibular Disorders
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dizziness
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FUI/FUCP/CTR/Neuro1/AqsaKhalil
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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