Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Final Head Shape
研究概览
简要总结
This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.
详细描述
Infants 2 months of age who have been diagnosed with a deformational head shape will be begin repositioning therapy (and physical therapy if torticollis is present) and be followed at least monthly. At 4, 5, and 6 months of age, if the head shape has not resolved, they will be given the option to pursue treatment with a cranial remolding orthosis. All affected infants will undergo active treatment until the head shape is resolved or the infant is 12 months of age (whichever comes first).
Normal infants will be evaluated at 2, 6, and 12 months of age and will not be enrolled in any active treatment.
All infants will return at 12 months of age for a final evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Control Group:
- •Healthy infants with normal physical development and no need for physical therapy intervention
排除标准
- •for Control Group:
- •Infants with abnormal head shapes (plagiocephaly or craniosynostosis)
- •Infants with growth abnormalities (such as genetic conditions)
- •Infants with developmental delay significant to warrant physical therapy or occupational therapy
研究组 & 干预措施
Repositioning Therapy
Infants will be treated with at-home repositioning strategies for their deformational head shape. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.
干预措施: Repositioning Therapy (Other)
Repositioning Therapy + Cranial Remolding Orthoses
After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.
干预措施: Repositioning Therapy (Other)
Repositioning Therapy + Cranial Remolding Orthoses
After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.
干预措施: Cranial Remolding Orthosis (Device)
Control
Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.
结局指标
主要结局
Final Head Shape
时间窗: 10 months after enrollment (at 12 months of age)
Cranial measurements will be used to assess residual cranial deformation in affected infants. A group of unaffected, typically-developing infants will be used as normal growth examples. Measurements include 2-dimensional measurements (taken at the greater equator of the skull with cranial calipers or a measuring tape): Cranial circumference, medio-lateral dimension of the skull, anterior-posterior dimension of the skull, two opposing diagonal measurements taken 30 degrees from the mid-sagittal line. These will be used to calculate the asymmetry and proportion of the skull and track growth. Measurements include 3-dimensional measurements: 1) An FDA-approved non-invasive, eye-safe laser scanner called the STARscanner will be used to track measurements throughout treatment. For those who switch to Cranial Remolding Therapy, this scanner will be used for custom helmet fabrication. 2) The 3dMD system will use photographs to create a 3-dimensional rendering of your child's head.
次要结局
- Overall Change in Head Shape(Assessment to occur within 2 years of enrollment closure.)
- Compliance with treatment(Assessment to occur within 2 years of enrollment closure.)
研究者
Tiffany Graham
Assistant Professor
University of Texas Southwestern Medical Center