Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Passive Cervical Lateral Flexion Range of movement
研究概览
简要总结
This study evaluates the efficacy of Pediatric Integrative Manual Therapy in the treatment of positional plagiocephaly in infants. 25 participants will receive a protocol of Pediatric Integrative Manual Therapy and educational physiotherapy in combination, while the other 25 will receive a stretching protocol and 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. When babies present preferential position of the head or Congenital Muscular Torticollis, stretching has shown efficacy.
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 a protocol of stretching at home done by their parents and 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
Double (Investigator, Outcomes Assessor) The assessors who receive participants and do the measurement are masked
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign of positional plagiocephaly
- •Infants below 12 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
Passive Cervical Lateral Flexion Range of movement
时间窗: 10 weeks
Measured lying down with joint goniometer
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
Active Cervical Rotation Range of movement
时间窗: 10 weeks
Measured with digital angular analysis
Passive Cervical Rotation Range of movement
时间窗: 10 weeks
Measured lying down with joint goniometer
Muscle Function Test
时间窗: 10 weeks
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
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
次要结局
- Cranial maximal circumference(10 weeks)
- Cranial wide(10 weeks)
- Alberta Infant Motor Scale(10 weeks)
- Visual Analogical Scale about improvement in cervical movement after intervention(10 weeks)
- Cranial length(10 weeks)
- Visual Analogical Scale about improvement in cranial asymmetry after intervention(10 weeks)
研究者
Iñaki Pastor Pons
Principal Investigator at Manual Therapy Research Unit
Universidad de Zaragoza