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- Ensayo clínico NCT07778654
Vestibular Stimulation Versus Foot Intrinsic Muscle Exercises in Children With Down Syndrome (VESTIB-FIME)
Effects of Vestibular Stimulation VS Foot Intrinsic Muscles Exercises on Balance and Functional Mobility in Children With Down's Syndrome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Down syndrome (DS) is a genetic disorder commonly associated with hypotonia, ligamentous laxity, impaired postural control, motor incoordination, and balance difficulties. These impairments can negatively affect functional mobility and participation in activities of daily living. Balance is one of the major functional domains affected in children and adolescents with Down syndrome. Postural instability may result in increased displacement of the center of mass during gait and center of pressure during standing, which can further affect gait performance, transfers, and other functional activities.
Pes planus (flat foot) is also frequently observed in individuals with Down syndrome and may contribute to impaired balance, physical activity, and quality of life. Vestibular stimulation exercises (VSE) provide repetitive sensory information regarding body position, movement, and orientation in space and may improve postural control and balance. Similarly, foot intrinsic muscle exercises (FIMEs) aim to strengthen the muscles responsible for foot stability and may improve foot function, postural control, gait, and functional mobility.
Previous studies have reported beneficial effects of vestibular stimulation and foot intrinsic muscle exercises when used independently in individuals with Down syndrome or balance-related impairments. However, there is limited research directly comparing these two approaches in children with Down syndrome. Therefore, this study will compare the effects of vestibular stimulation exercises and foot intrinsic muscle exercises on balance and functional mobility in children aged 4-15 years with Down syndrome.
Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated using the Timed Up and Go (TUG) test. The study aims to determine which intervention provides greater improvement in balance and functional mobility. The findings may help physiotherapists and rehabilitation professionals select an appropriate exercise approach for children with Down syndrome and contribute to the development of more effective pediatric rehabilitation strategies.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: laiba shad, DPT
- Número de teléfono: 03066493073
- Correo electrónico: laibashad27@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: arooj hanif, DPT
- Número de teléfono: 03206550216
- Correo electrónico: aroojhanif6@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- • Children with Down syndrome with age range (4-15 years) both male and female children included [12]. • Children who are able to stand and walk/ambulate independently and follow verbal instructions and commands and comply with intervention protocol [13]. • No visual and hearing impairment • Parent/guardian willing to provide consent for participant
Exclusion Criteria:
- Associated congenital heart disease • Hearing impairment, eye problems such as cataract or other visual impairment • Dementia and cognitive decline. • Lower limb trauma or surgical intervention within the previous 6 months affecting comprehension or ability to perform balance/mobility activities [13]
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Vestibular Stimulation Exercise Group
Participants in this group will receive vestibular stimulation exercises 3 times per week for 8 weeks, for a total of 24 sessions.
Each session will last 20 minutes, with a 5-minute rest interval.
The intervention will include spinning while sitting on a Swiss ball, sliding while lying on a large roller pillow, and vertical bouncing while sitting on a roller.
Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12).
Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
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A structured vestibular stimulation exercise program designed to improve postural control, balance, and functional mobility in children with Down syndrome.
The program includes sensory-motor activities involving controlled rotational, linear, and vertical movements.
Otros nombres:
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Experimental: Foot Intrinsic Muscle Exercises
Participants in this group will receive foot intrinsic muscle exercises 3 times per week for 8 weeks, for a total of 24 sessions.
Each session will last 20 minutes, with a 5-minute rest interval.
The intervention will include toe curls, marble pickups, short foot exercises, ball rolling, heel raises, step-ups, and football kicking.
Seated calf stretching will be performed as a warm-up and cool-down before and after strengthening exercises.
Balance and functional mobility will be assessed at baseline (Week 0), immediately after the intervention (Week 8), and at follow-up (Week 12).
Balance will be measured using the Pediatric Balance Scale (PBS), and functional mobility will be assessed using the Timed Up and Go (TUG) test.
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A structured foot muscle strengthening program designed to improve foot stability, postural control, balance, and functional mobility in children with Down syndrome.
The program targets the intrinsic muscles of the foot through functional strengthening activities.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Balance Measured by the Pediatric Balance Scale (PBS)
Periodo de tiempo: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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Balance will be assessed using the Pediatric Balance Scale (PBS), a 14-item clinical measure of functional balance in children.
The total score ranges from 0 to 56, with higher scores indicating better balance.
The change in PBS score from baseline will be evaluated to determine the effect of the interventions on balance.
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Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test
Periodo de tiempo: Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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Functional mobility will be assessed using the Timed Up and Go (TUG) test.
The TUG measures the time, in seconds, required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
A shorter completion time indicates better functional mobility.
The change in TUG completion time from baseline will be evaluated.
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Baseline (Week 0), immediately post-intervention (Week 8), and follow-up (Week 12)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: DR SADAF TABASSAM, PHD, Shalamar Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Bu Q, Qiang R, Cheng H, et al. Front Pediatr. 2022;10:882722. Khan F, Rahiyab M, Hussain I, et al. Int Health Rev. 2025;5(2):19-44. Giustino V, Messina G, Alesi M, et al. Hum Mov. 2021;22(1):66-71. Nahla IM, El-Sayed SE, Ragaa AE, et al. Afr Health Sci. 2022;22(1):377-383. Tuncer D, Erekdag A, Senaran H, et al. Eur J Pediatr. 2025;184:636. Halwsh SD, Algabbani MF, Alqabbani S, et al. Brain Sci. 2026;16(1):79. Siddiqui M, Farooqui S, Rizvi J, et al. Ann King Edward Med Univ. 2024;30(2):112-118. Ghouri EURK, Memon AG, Ali S, et al. J Liaquat Univ Med Health Sci. 2024;23(2):116-120. Adeeba N, Farooqui SI, Hasan ZM, et al. Dev Neurorehabil. 2024;27(5-6):145-153.
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
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Genéticas Congénitas
- Manifestaciones neuroconductuales
- Anomalías congénitas
- Anomalías Múltiples
- Discapacidad intelectual
- Trastornos cromosómicos
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Síndrome de Down
Otros números de identificación del estudio
- SSAHS-2026-1126
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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