跳至主要内容
临床试验/NCT02403011
NCT02403011Unknown不适用

A Randomized Controlled Study in the Efficiency of Soft Tissue Mobilization in Babies With Congenital Muscular Torticollis and Deformational Plagiocephaly

Hacettepe University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Head tilt with photographic method

研究概览

简要总结

This study investigates the effect of soft tissue mobilization in babies with neck muscle problem. Babies received soft tissue mobilization or home exercises program

详细描述

Objectives: Investigating the effectiveness of soft tissue mobilization in babies with congenital muscular torticollis and deformational plagiocephaly.

Design: A Randomized controlled trial design Setting: University research department Participants:Babies with congenital muscular torticollis, aged between 0-6 months, who had a head tilt from 5 to 20 degrees and no other health problems were the participants of the study. The study included two groups; home program group was seen once every six weeks, the study group in addition to the home program also received soft tissue mobilization three times in a week. All groups received a baseline home program consisting of positioning, handling strategies plus stretching, stretching and strengthening exercises, environmental adaptations and classical massage. Babies were allocated to two groups by sealed envelope randomization. Babies were evaluated initially, at sixth weeks, at 12 weeks and follow-up at 18 weeks with muscle function scale, head tilt and ear shift assessments which included photographing method, neck normal range of motions (lateral flexion and rotation) and plagiocephaly severity scale

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
Single (Participant)

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Babies with congenital muscular torticollis and secondary deformational plagiocephaly
  • •Head tilt from 5 to 20 degrees
  • •Age between 0-6 months

排除标准

  • •Have another health problem such as neurological, vertebral anomalies, craniosynostosis

研究组 & 干预措施

Soft tissue mobilization group

Experimental

soft tissue mobilization was applied three times in a week and home program exercises were recommended which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations

干预措施: soft tissue mobilization (Other)

Home program controlled once six weeks

Experimental

Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations were recommended

干预措施: home program controlled once six weeks (Other)

结局指标

主要结局

Head tilt with photographic method

时间窗: Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks

Baby lies supine while taking photo of baby's habitual head position. The angle between the two lines, connecting eyes pupils and connecting acromions, is assessed.

plagiocephaly severity scale

时间窗: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks

scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry.

次要结局

  • Passive range of motion(Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

hhotaman

Research Assistant, PhD, PT

Hacettepe University

研究点 (1)

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