- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07663721
The Effects of Weight Shift Training on the Symmetry of Upper Extremity Weight Bearing in the Prone Position in Infants With Congenital Muscular Torticollis
Congenital muscular torticollis(CMT) is a common musculoskeletal condition in infancy that may result in asymmetrical posture and weight-bearing patterns, limited cervical range of motion, and delayed motor development. This randomized controlled trial aims to investigate the effects of weight shift training on upper extremity weight-bearing symmetry in infants with CMT.
A total of 30 infants aged 6 to 12 months diagnosed with CMT will be randomly assigned to either an experimental group(n = 15) or a control group(n = 15). The experimental group will receive weight shift training in prone and sitting positions in addition to stretching exercises, while the control group will receive stretching exercises only. Both groups will participate in 30-minute intervention sessions three times per week for eight weeks.
The primary outcome is upper extremity weight-bearing symmetry, which will be assessed using the Balancia software system. Secondary outcomes include motor development assessed by the Alberta Infant Motor Scale(AIMS), head tilt angle, and passive cervical rotation range of motion. The findings of this study may provide evidence regarding the effectiveness of weight shift training in improving postural symmetry and motor function in infants with congenital muscular torticollis.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Congenital muscular torticollis(CMT) is a musculoskeletal condition characterized by unilateral shortening or tightness of the sternocleidomastoid muscle, resulting in head tilt, limited cervical range of motion, and postural asymmetry. Infants with CMT frequently demonstrate asymmetrical weight bearing patterns.
Early physical therapy interventions, including stretching exercises, are widely used to improve cervical mobility and reduce postural asymmetry. However, interventions specifically targeting symmetrical weight bearing and postural control may provide additional benefits by promoting more symmetrical development in functional activities.
Weight shift training encourages active transfer of body weight while maintaining postural stability. Improved weight bearing symmetry may contribute to more efficient motor development and functional movement patterns in infants with CMT.
The purpose of this study is to determine whether the addition of weight shift training to conventional stretching exercises improves upper extremity weight-bearing symmetry, motor development, head posture, and cervical mobility in infants with congenital muscular torticollis. The findings of this study may provide evidence for the clinical effectiveness of incorporating weight shift training into rehabilitation programs for infants with CMT.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: junyeong Heo, PT
- Número de teléfono: +82-10-4206-3290
- Correo electrónico: hamstering99@naver.com
Ubicaciones de estudio
-
-
Gyeonggi-do
-
Yongin-si, Gyeonggi-do, Corea del Sur, 16943
- EZ Rehabilitation Medicine Clinic
-
Contacto:
- junyeong Heo, PT
- Número de teléfono: +82-10-4206-3290
- Correo electrónico: hamstering99@naver.com
-
Investigador principal:
- junyeong Heo, PT
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosed with congenital muscular torticollis by a physician
- Head tilt angle of 15 degrees or greater and limitation of passive cervical rotation range of motion
- Able to independently maintain the prone position and demonstrate asymmetrical upper extremity weight bearing
Exclusion Criteria:
- Diagnosed with non-muscular torticollis, including postural torticollis or ocular torticollis
- Presence of congenital cervical spine abnormalities or neurological complications
- Any medical condition that may interfere with participation in the intervention or outcome assessments
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 |
|---|---|
|
Experimental: Weight Shift Training + Stretching
Experimental groups will receive weight shift training in prone and sitting positions in addition to stretching exercises.
The intervention will be provided for 30 minutes per session, three times per week, for eight weeks.
|
Weight shift training will be performed in prone and sitting positions to facilitate symmetrical weight bearing and postural control in infants with congenital muscular torticollis.
Stretching exercises will be performed to improve head tilt and cervical range of motion in infants with congenital muscular torticollis.
|
|
Comparador activo: Stretching Only
Control groups will receive stretching exercises only.
The intervention will be provided for 30 minutes per session, three times per week, for eight weeks.
|
Stretching exercises will be performed to improve head tilt and cervical range of motion in infants with congenital muscular torticollis.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Symmetry of Upper Extremity Weight Bearing in the Prone Position
Periodo de tiempo: Baseline and Week 8
|
Symmetry of Upper extremity weight bearing in the prone position will be assessed using the Balancia software system.
Weight bearing distribution between the left and right upper extremities will be measured.
|
Baseline and Week 8
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Head tilt
Periodo de tiempo: Baseline and Week 8
|
Head tilt will be measured to evaluate postural asymmetry associated with congenital muscular torticollis.
|
Baseline and Week 8
|
|
Cervical rotation passive range of motion
Periodo de tiempo: Baseline and Week 8
|
Cervical rotation passive range of motion will be measured using standard clinical assessment procedures.
|
Baseline and Week 8
|
|
Motor Development Assessed by the Alberta Infant Motor Scale
Periodo de tiempo: Baseline and Week 8
|
Motor development will be assessed using the Alberta Infant Motor Scale.
The Alberta Infant Motor Scale is an observational measure of infant motor development with scores ranging from 0 to 58, where higher scores indicate better motor development.
|
Baseline and Week 8
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: junyeong Heo, PT, Sahmyook University
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
- Tortícolis congénita
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Ejercicio
- Ejercicios de estiramiento muscular
Otros números de identificación del estudio
- SYU 2026-04-026-003
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
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .