Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Left Oblique Cranial Vault Diameter
研究概览
简要总结
This study evaluates the efficacy of Pediatric Manual Therapy in the treatment of positional plagiocephaly in infants. 40 participants will receive a protocol of Pediatric Manual Therapy and educational physiotherapy in combination, while the other 20 will receive only educational physiotherapy
详细描述
The Manual Therapy has shown efficacy in different pathologies in the adult but it is not know its utility in infants and children population, nor in specific pathologies as non synostotic plagiocephaly.
In the conservative treatment of plagiocephaly the educational physiotherapy and the helmet therapy have the better level of evidence among other treatments.
A protocol of ten sessions of Pediatric Manual Therapy will be applied to infants with positional plagiocephaly in combination with educational physiotherapy. The protocol consists in soft cervical mobilisation, myofascial induction and the application of some pressures to the cranial bones to improve the asymmetry of the head. Educational therapy which consists in more "tummy time" stimulation, stimulation to the non preference position of the head and counter positioning.
The control group will receive only Educational therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The assessors who receive participants and do the measurement are masked
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign of positional plagiocephaly
- •Infants below 6 moths age
排除标准
- •No neurological disorders
- •No infectious diseases
- •No respiratory diseases
- •No other treatments
结局指标
主要结局
Left Oblique Cranial Vault Diameter
时间窗: 10 weeks
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Right Oblique Cranial Vault Diameter
时间窗: 10 weeks
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
次要结局
- Cranial circumference(10 weeks)
- Cranial length(10 weeks)
- Cranial wide(10 weeks)
研究者
Iñaki Pastor Pons
Researcher at PhD School
Universidad de Zaragoza