Clinical Trial: Investigating the Effectiveness of Mobilization on Congenital Muscular Torticollis and Deformational Plagiocephaly

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:

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


Sponsor: Hacettepe University

Current Primary Outcome:

  • Head tilt with photographic method [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Passive range of motion [ Time Frame: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks ]

Baby lies in supine position and caregiver holds the baby's upper extremities by stabilizing shoulders to prevent compansatuar movements. For lateral flexion therapist bends the neck to opposite side from affected SCM. For neck rotation, therapist rotate the neck to affected SCM.


Original Secondary Outcome: Same as current

Information By: Hacettepe University

Dates:
Date Received: March 15, 2015
Date Started: January 2014
Date Completion: November 2015
Last Updated: November 6, 2015
Last Verified: November 2015