- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- 1-Km Defence Road, near Bhuptian Chowk, Lahore, Pakistan.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Balance
Periodo de tiempo: 6 semanas
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6 semanas
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Arooj Fatima
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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