- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07583901
Effects of Gaze Stabilization Exercises and Optokinetic Training in Peripheral Vestibular Disorders
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dizziness
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FUI/FUCP/CTR/Neuro1/AqsaKhalil
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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