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

Primary Purpose

Congenital Muscular Torticollis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
soft tissue mobilization
home program controlled once six weeks
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Muscular Torticollis focused on measuring Congenital Muscular Torticollis, Manual Therapy, Infant

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hacettepe University Faculty of Health Sciences Department of Physiotherapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Soft tissue mobilization group

Home program controlled once six weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Passive range of motion
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.

Full Information

First Posted
March 15, 2015
Last Updated
November 6, 2015
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02403011
Brief Title
Investigating the Effectiveness of Mobilization on Congenital Muscular Torticollis and Deformational Plagiocephaly
Official Title
A Randomized Controlled Study in the Efficiency of Soft Tissue Mobilization in Babies With Congenital Muscular Torticollis and Deformational Plagiocephaly
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Muscular Torticollis
Keywords
Congenital Muscular Torticollis, Manual Therapy, Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soft tissue mobilization group
Arm Type
Experimental
Arm Description
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
Arm Title
Home program controlled once six weeks
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
soft tissue mobilization
Intervention Description
soft tissue mobilization technique has three phases. First phase 'the passive mobilization phase' is applied by gentle but tight gripping of the SKM muscle two or three fingers below the muscle origo and the muscle is mobilized rhythmically in the antero-posterior direction. Secondly, after gently continue to hold the muscle the baby was encouraged to do active repetitive cervical rotation to the affected side by means of catching the babies attention with colored and sonorous toys. Third phase was mobilization with stretching. Caregiver holds the baby on his/ her affected side while the therapist gently grips and withholds the muscle. Therapist mobilizes the muscle in the antero-posterior direction and stretch the muscle
Intervention Type
Other
Intervention Name(s)
home program controlled once six weeks
Intervention Description
Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations
Primary Outcome Measure Information:
Title
Head tilt with photographic method
Description
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.
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
Title
plagiocephaly severity scale
Description
scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry.
Time Frame
Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
Secondary Outcome Measure Information:
Title
Passive range of motion
Description
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.
Time Frame
Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Babies with congenital muscular torticollis and secondary deformational plagiocephaly Head tilt from 5 to 20 degrees Age between 0-6 months Exclusion Criteria: Have another health problem such as neurological, vertebral anomalies, craniosynostosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilal KEKLİCEK, PhD, PT
Phone
0903123051576
Ext
138
Email
hhotaman23@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma UYGUR, Prof, PhD
Phone
0903123051576
Ext
139
Email
fztuygur@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal KEKLİCEK, PhD,PT
Organizational Affiliation
Hacettepe University,Faculty of Health Sciences Department of Physiotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayse KARADUMAN
First Name & Middle Initial & Last Name & Degree
Fatma UYGUR, PT PhD
First Name & Middle Initial & Last Name & Degree
Hilal KEKLICEK, PT MSc

12. IPD Sharing Statement

Learn more about this trial

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

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