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临床试验/NCT02403011
NCT02403011
Unknown
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2014年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Congenital Muscular Torticollis
发起方
Hacettepe University
入组人数
30
试验地点
1
主要终点
Head tilt with photographic method
最后更新
10年前

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

注册库
clinicaltrials.gov
开始日期
2014年1月
结束日期
2015年11月
最后更新
10年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

hhotaman

Research Assistant, PhD, PT

Hacettepe University

入排标准

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

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)

研究点 (1)

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