- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07754747
Effects of Vestibular-Oriented Balance Training Versus Motor Dual Task Training on Balance, Postural Control, and Fall Risk in Chronic Stroke Survivors
Effects of Vestibular-Oriented Balance Training Versus Motor Dual Task Training on Balance, Postural Control, and Fall Risk in Chronic Stroke SurvivorsIIUI/RERC
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke is one of the leading causes of long-term disability worldwide and is associated with significant impairments in balance, postural control, mobility, and functional independence. Balance dysfunction remains one of the most challenging complications in chronic stroke survivors despite conventional rehabilitation interventions.
Vestibular-Oriented Balance Training (VOBT) is an evidence-based rehabilitation approach designed to improve balance by stimulating the vestibular system and enhancing sensory integration. This intervention includes exercises involving head movements, gaze stabilization, balance challenges on stable and unstable surfaces, dynamic postural tasks, and coordinated body movements.
Although both Vestibular-Oriented Balance Training and Motor Dual Task Training have demonstrated beneficial effects individually, there is limited high-quality evidence directly comparing their effectiveness in improving balance, postural control, and fall risk among chronic stroke survivors. Identifying the more effective rehabilitation strategy would assist physiotherapists in selecting evidence-based interventions that optimize patient recovery and functional independence.
The present study is designed as a randomized controlled trial to compare the effects of Vestibular-Oriented Balance Training and Motor Dual Task Training on balance, postural control, and fall risk in individuals with chronic stroke. A total of 50 eligible participants diagnosed with chronic stroke will be recruited using predefined inclusion and exclusion criteria. Participants will be randomly allocated into two parallel intervention groups using a computer-generated randomization sequence.
Participants allocated to the experimental group will receive Vestibular-Oriented Balance Training in addition to conventional physiotherapy. The intervention will consist of progressive vestibular exercises including gaze stabilization, head movement exercises, balance training on different support surfaces, weight-shifting activities, dynamic standing balance tasks, reaching activities, stepping exercises, and functional gait activities. The intensity and difficulty of the exercises will be progressively increased according to each participant's performance and tolerance throughout the intervention period.
Participants allocated to the active comparator group will receive Motor Dual Task Training together with the same conventional physiotherapy program. The intervention will include simultaneous performance of balance and mobility tasks combined with functional motor activities such as walking while carrying objects, obstacle negotiation, reaching during standing, stepping while manipulating objects, and other progressively challenging motor dual-task exercises. Exercise progression will be individualized according to participant performance to ensure safety and maximize functional improvement.
Both groups will receive intervention sessions three times per week for five consecutive weeks. Each treatment session will last approximately 45 to 60 minutes. Conventional physiotherapy will be standardized across both groups to ensure that the only difference between groups is the assigned experimental intervention.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hafsah Arshad, PhD*
- Número de teléfono: 03315165234
- Correo electrónico: hafsah.arshad@uipt.iiui.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Ijaz Ahmed, MS-NMPT
- Número de teléfono: +923437149637
- Correo electrónico: ejaza788@gmail.com
Ubicaciones de estudio
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Rawalpindi, Pakistán, 46000
- Reclutamiento
- Armed Forces Institute of Rehabilitation Medicine Rawalpindi, Pakistan
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Contacto:
- Ijaz Ahmed, MS-NMPT
- Número de teléfono: +923437149637
- Correo electrónico: ejaza788@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosis of ischemic stroke.
- Stroke duration ≥6 months.
- Rhomberg scale
- MMSE ≥ 24
- Able to walk with or without assistive device.
- Able to understand commands
- Willing to participate and provide consent aged between 40-70 years.
Exclusion Criteria:
- Severe visual impairements which effect balance.
- Participants with acute or sub acute stroke <6 moths.
- Uncontrolled hypertension
- Uncontrolled diabetes
- Other neurological disorders such as Parkinson's disease or multiple sclerosis and Alzheimer's
- Participation in any other interventional trail.
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-Oriented Balance Training
Participants will receive vestibular-oriented balance exercises together with conventional physiotherapy for five weeks
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Participants will receive vestibular-oriented balance exercises together with conventional physiotherapy for five weeks
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|
Comparador activo: Motor Dual Task Training
Participants will receive motor dual-task balance training together with conventional physiotherapy for five weeks
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Participants will receive motor dual-task balance training together with conventional physiotherapy for five weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biodex Over all stability Index
Periodo de tiempo: assessment at baseline and after 6 weeks
|
Overall Stability Index (OSI) on the Biodex Balance System is a comprehensive score measuring how well a person controls their balance and keeps a moving platform level.
Higher numbers mean more platform tilt and poorer balance control, while lower numbers show better stability and stronger neuromuscular coordination.
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assessment at baseline and after 6 weeks
|
|
Biodex Fall Risk index
Periodo de tiempo: at baseline and after 6 weeks
|
It measures a person's stability and risk of falling by tracking how much they sway on a moveable balance platform.
Higher scores indicate poor stability and a higher likelihood of falls
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at baseline and after 6 weeks
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Modified clinical test of sensory interaction on balance
Periodo de tiempo: at baseline and after 6 weeks
|
a clinical tool used to evaluate static postural control and identify which sensory systems (vision, vestibular, or somatosensory/proprioceptive) a patient relies on or struggles with to maintain balance.
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at baseline and after 6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biodex APSI
Periodo de tiempo: at baseline and after 6 weeks
|
Anterior/Posterior Stability Index (APSI) on the Biodex Balance System measures front-to-back postural sway and balance ability.
Higher scores indicate greater platform displacement and poorer stability, while lower scores reflect better front-to-back neuromuscular control and stability.
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at baseline and after 6 weeks
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Biodex Medial/Lateral Stability Index
Periodo de tiempo: at baseline and after 6 weeks
|
A lower score indicates better stability, meaning the person stayed closer to the center level.
A higher score represents greater side-to-side sway, indicating poor postural performance or a higher risk of falling.
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at baseline and after 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIUI/RERC/ADT/2026/07/366
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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