- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07804836
Investigation of Muscle Activity With sEMG, Surface Topography and Radiographic Changes of Paraspinal Muscles in Individuals With Adolescent Idiopathic Scoliosis.
Investigation of Muscle Activity, Surface Topography and Radiographic Changes of Paraspinal Muscles in Individuals With Adolescent Idiopathic Scoliosis.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study was designed to examine paraspinal muscle activity, surface topography, and radiographic characteristics in adolescents with idiopathic scoliosis. The study plans to include adolescents aged 10-18 years diagnosed with idiopathic scoliosis, as well as healthy volunteers matched for age and gender.
Participants will be divided into three groups: adolescents with idiopathic scoliosis who wear a brace, adolescents with idiopathic scoliosis who do not wear a brace, and a healthy control group. A total of 45 participants are planned to be included in the study, with 15 participants in each group.
As part of the study, participants' demographic information will be recorded. Muscle activity in the paraspinal muscles will be assessed using surface electromyography (sEMG). Body surface topography will be assessed using an Artec Eva 3D scanner. Posture analysis will be performed, and spinal curvature will be assessed using the Cobb angle based on existing radiographic images. Quality of life will be determined using the Scoliosis Research Society-22 (SRS-22) questionnaire.
The measurement results obtained will be compared across groups, and the relationships between muscle activity, surface topography, postural characteristics, radiographic parameters, and quality of life will be evaluated.
As part of this study, participants will not receive any treatment or rehabilitation interventions; measurements will be taken to assess their current clinical and physical characteristics.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
- Be between the ages of 10 and 18
- Have been diagnosed with adolescent idiopathic scoliosis
- Be able to stand independently
- Sign the informed consent form
- Have no spinal deformity (for the control group)
- History of neurological disease
- History of spinal surgery
- Presence of congenital or traumatic scoliosis
- Presence of orthopedic or rheumatological conditions that could affect the measurements
- Inability to cooperate during the measurements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Study Participants
The study participants include adolescents with adolescent idiopathic scoliosis, including individuals who use a brace and those who do not use a brace, as well as healthy control individuals who meet the eligibility criteria.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Paraspinal Muscle Activity
Periodo de tiempo: Baseline (single assesment)
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Paraspinal muscle activity will be assessed using surfaces electromyography (sEMG) in adolescents with adolescent idiopathic scoliosis and healthy controls.
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Baseline (single assesment)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Surface Topography
Periodo de tiempo: Baseline (single assesment)
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Surface topography will be assessed to evaluate trunk surface characteristics in adolescents with adolescent idiopathic scoliosis and healthy controls.
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Baseline (single assesment)
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Radiographic Parameters
Periodo de tiempo: Baseline (single assesment)
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Radiographic parameters will be evaluated to assess spinal alignment in adolescents with adolescent idiopathic scoliosis.
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Baseline (single assesment)
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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
Otros números de identificación del estudio
- Paraspinal muscles for AIS
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