- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07777692
Vestibular Rehabilitation Exercises to Improve Gait, Balance, and Dynamic Visual Acuity in Patients With Vestibular Hypofunction
## Brief Summary
Unilateral vestibular hypofunction (UVH) is a condition characterized by reduced or absent function of one vestibular system and commonly results in dizziness, impaired postural control, gait difficulties, reduced dynamic visual acuity, and increased risk of falls. These impairments can substantially affect functional independence and quality of life. Vestibular rehabilitation therapy (VRT) is an exercise-based physiotherapy approach designed to promote central vestibular compensation through gaze stabilization, habituation, balance, and gait training. However, the evidence comparing the additional benefits of VRT with conventional physiotherapy, particularly in the local population, remains limited. Therefore, this study was conducted to determine and compare the effects of VRT and conventional physiotherapy on balance, gait, dynamic visual acuity, and dizziness-related disability in patients with chronic unilateral vestibular hypofunction.
A single-blinded randomized controlled trial was conducted on 58 participants aged 38-60 years with chronic unilateral vestibular hypofunction. Participants were randomly allocated into an experimental group and a control group, with 29 participants in each group. The experimental group received conventional physiotherapy combined with vestibular-specific rehabilitation, including VOR x1/x2 gaze stabilization, postural stability exercises, and habituation exercises. The control group received conventional physiotherapy consisting of core strengthening and gait training without vestibular-specific interventions. Both groups received treatment twice weekly for eight weeks, with each session lasting approximately 45 minutes. Outcome measures included the Timed Up and Go (TUG) test for functional mobility, Dynamic Visual Acuity (DVA) for visual stability, Dizziness Handicap Inventory (DHI) for dizziness-related disability, and Tandem Romberg testing for balance.
The findings demonstrated greater improvements in the experimental group across the assessed outcomes. TUG performance improved, while DVA and DHI scores showed marked improvement, indicating better visual stability and reduced dizziness-related disability. Romberg performance also improved substantially, reflecting enhanced postural stability and balance control. In comparison, the control group demonstrated smaller or inconsistent changes, particularly in DVA, DHI, and functional mobility. Statistical analysis was performed using non-parametric tests because most study variables were not normally distributed. Within-group comparisons were conducted using the Wilcoxon Signed-Rank Test, while between-group comparisons were performed using the Mann-Whitney U Test.
The study concluded that vestibular rehabilitation therapy is an effective intervention for improving balance, dynamic visual acuity, and dizziness-related disability in patients with unilateral vestibular hypofunction. The experimental group showed greater improvements in postural stability, visual stability, and perceived disability than the conventional physiotherapy group. However, no significant between-group difference was observed for TUG, suggesting that conventional physiotherapy may provide adequate improvement in basic functional mobility. Overall, the findings support incorporating vestibular rehabilitation into physiotherapy management of UVH to enhance sensory integration and functional recovery.
The study recommends early initiation of VRT, individualized exercise programs, and emphasis on home exercises to improve adherence and long-term outcomes. Future research should involve larger samples, multicenter studies, longer follow-up periods, and investigation of optimal exercise dosage and progression.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- 1-Km Defence Road, near Bhuptian Chowk, Lahore, Pakistan.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
• Age group of 39 - 60 was included in this study. (Grill et al., 2018)
- Both male and female gender
- Participants who have chronic condition (past 3 months) (Karabulut et al., 2023)
- Diagnostic tests:
- Tandem Romberg with eyes closed (<30s)
- Timed Up and Go (6 s) - Single leg stance with eyes closed
- Timed Up and Go (7 s) Tandem Romberg with eyes closed
- Timed Up and Go (8 s) Standing on foam with eyes closed (Salah et al., 2020)
- Referred patient were confirmed by dynamic visual acuity test (DVAT)(Vital et al., 2010).
Exclusion Criteria:
• Dizziness associated with other neurological conditions (e.g Stroke, diabetic neuropathy) (Yang et al., 2024)
- Bilateral vestibular hypofunction was excluded (Karabulut et al., 2023)
- Patients diagnosed with other neurological conditions that may affect balance, gait, or vestibular function, such as multiple sclerosis, Parkinson's disease, cerebellar ataxia etc. (Hall et al., 2022)
- Participants with cognitive dysfunction (Hall et al., 2022)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Vestibular Rehabilitation Therapy + Conventional Physiotherapy
Participants in this group will receive vestibular rehabilitation therapy in addition to conventional physiotherapy for 8 weeks.
Vestibular rehabilitation will include gaze stabilization exercises (VOR x1/x2), habituation exercises, and balance training.
Treatment will be provided twice weekly, with each session lasting approximately 45 minutes.
|
Vestibular rehabilitation therapy consisting of gaze stabilization exercises (VOR x1/x2), habituation exercises, and balance training, administered in addition to conventional physiotherapy.
The intervention will be provided twice weekly for 8 weeks, with each session lasting approximately 45 minutes.
Conventional physiotherapy consisting of core strengthening and gait training, administered for 8 weeks.
Participants received treatment twice weekly.
|
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Aktivní komparátor: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy alone for 8 weeks.
The conventional physiotherapy program will include core strengthening and gait training without the vestibular-specific rehabilitation program.
|
Vestibular rehabilitation therapy consisting of gaze stabilization exercises (VOR x1/x2), habituation exercises, and balance training, administered in addition to conventional physiotherapy.
The intervention will be provided twice weekly for 8 weeks, with each session lasting approximately 45 minutes.
Conventional physiotherapy consisting of core strengthening and gait training, administered for 8 weeks.
Participants received treatment twice weekly.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Zůstatek
Časové okno: 6 týdnů
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6 týdnů
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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
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