- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07758712
Effectiveness of a Horse Riding Simulator in Adolescents With Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity associated with impaired respiratory muscle strength, balance, postural control, body image, and health-related quality of life. Core stabilization exercises are widely used in the conservative management of AIS. Horse riding simulator training reproduces the multidirectional rhythmic movements of horseback riding while eliminating the potential risks associated with conventional hippotherapy and may provide additional benefits for postural control and trunk muscle activation.
The aim of this randomized controlled trial is to investigate the effects of adding horse riding simulator training to a core stabilization exercise program on respiratory muscle strength, balance, health-related quality of life, and perceived cosmetic deformity in adolescents with idiopathic scoliosis. Participants will be randomly assigned to either an experimental group receiving horse riding simulator training combined with core stabilization exercises or a control group receiving core stabilization exercises alone. Outcomes will be assessed before and after the 12-week intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sefa Yıldırım
- Número de teléfono: +905385984870
- Correo electrónico: syildirim@bezmialem.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Reclutamiento
- Bezmialem Vakıf University
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Contacto:
- Sefa Yıldırım
- Número de teléfono: +905395984870
- Correo electrónico: syildirim@bezmialem.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosis of adolescent idiopathic scoliosis
- Age between 10 and 19 years
- Cobb angle between 10° and 40°, measured on standing spinal radiographs
- Willingness of the participant and, when applicable, the parent or legal guardian to participate in the study
Exclusion Criteria:
- Scoliosis of a non-idiopathic etiology
- History of surgery within the previous 3 months
- Presence of an orthopedic, neurological, or systemic condition that may prevent participation in the exercise program
- Cognitive, communication, or behavioral disorders that may interfere with understanding instructions, answering questions, or performing the exercises
- Participation in regular exercise on 3 or more days per week
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 |
|---|---|
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Experimental: Horse Riding Simulator + Core Stabilization
Participants will receive supervised 60-minute core stabilization exercises combined with 30-minute horse riding simulator training twice weekly for 12 weeks.
Home-based core stabilization exercises will be performed on the remaining days of the week.
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Participants will receive 30-minute horse riding simulator training twice weekly for 12 weeks in addition to supervised core stabilization exercises.
Each session consists of 5 minutes of warm-up at low speed, 20 minutes of training at the highest speed tolerated by the participant, and 5 minutes of cool-down at low speed.
Participants will perform supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be prescribed for the remaining days of the week.
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Comparador activo: Core Stabilization
Participants will receive supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be performed on the remaining days of the week.
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Participants will perform supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be prescribed for the remaining days of the week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Balance
Periodo de tiempo: Baseline and after 12 weeks
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Balance will be assessed using the Biodex Balance System.
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Baseline and after 12 weeks
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Respiratory Muscle Strength
Periodo de tiempo: Baseline and after 12 weeks
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Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable mouth pressure device.
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Baseline and after 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health-Related Quality of Life
Periodo de tiempo: Baseline and after 12 weeks
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Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire.
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Baseline and after 12 weeks
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Perceived Cosmetic Deformity
Periodo de tiempo: Baseline and after 12 weeks
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Perceived cosmetic deformity will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
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Baseline and after 12 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- BVUsyildirim04
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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