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Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly

Primary Purpose

Deformational Plagiocephaly

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home program
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deformational Plagiocephaly focused on measuring Deformational Plagiocephaly,Treatment,Compliance

Eligibility Criteria

1 Month - 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    seen once every six weeks

    seen once a week.

    Arm Description

    Parents will be educated about home program and they will be asked to control once every six weeks.

    Parents will be educated about home program and they will be asked to control once a week.

    Outcomes

    Primary Outcome Measures

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

    Secondary 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.

    Full Information

    First Posted
    November 16, 2015
    Last Updated
    November 16, 2015
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02607969
    Brief Title
    Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly
    Official Title
    Comparison the Effectiveness Control Frequency of Physiotherapy Home Program on Deformational Plagiocephaly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    November 2016 (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
    30 babies with Deformational Plagiocephaly (DP) due to the congenital muscular torticollis will be the participants of the study. The subjects will randomly allocated into the two home program groups; first home program group was seen once every six weeks (SxW), second home program group was seen once a week (OW). Parents will educate about the same home program which consisted of positioning the neck and head, sleep in alternating head positions and in side-laying to increase head shape symmetry and place infants, when awake and under supervision, regularly in the prone position a day to stimulate normal motor development (tummy time), decreasing the time spent in car seat at supine position. Environmental settings also will be given to challenge the baby look through from the side no flattening to room, place colorful and sonorous toys or mirror on the opposite of the flattening side, and stimulate active rotation by communicating with baby from this side. Handling strategies, stretching and strengthening exercises will be given for CMT. The parents will be reinforme if necessary. Positioning strategies will spread throughout the day.Plagiocephaly severity assessment scale (PSS) which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry will be used to evaluate severity of DP.
    Detailed Description
    30 babies with Deformational Plagiocephaly due to the congenital muscular torticollis will be the participants of the study. The subjects will randomly allocate into the two home program groups; first home program group was seen once every six weeks (SxW), second home program group was seen once a week (OW), by utilizing sealed envelope if babies met the following inclusion and exclusion criteria. After the initial evaluation, parents will be educate about the same home program which consisted of positioning the neck and head, sleep in alternating head positions and in side-laying to increase head shape symmetry and place infants, when awake and under supervision, regularly in the prone position a day to stimulate normal motor development (tummy time), decreasing the time spent in car seat at supine position. Environmental settings also will be given to challenge the baby look through from the side no flattening to room, place colorful and sonorous toys or mirror on the opposite of the flattening side, and stimulate active rotation by communicating with baby from this side. Handling strategies, stretching and strengthening exercises will be given CMT. One or two days after the first visit the parents will asked to come again and demonstrate how they had implemented the home program and what adaptations they had made. The parents will be reinformed if necessary. Positioning strategies will spread throughout the day. Participants will be allocated to the groups with sealed envelope randomization after parent will be given the same home program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deformational Plagiocephaly
    Keywords
    Deformational Plagiocephaly,Treatment,Compliance

    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
    seen once every six weeks
    Arm Type
    Experimental
    Arm Description
    Parents will be educated about home program and they will be asked to control once every six weeks.
    Arm Title
    seen once a week.
    Arm Type
    Experimental
    Arm Description
    Parents will be educated about home program and they will be asked to control once a week.
    Intervention Type
    Other
    Intervention Name(s)
    Home program
    Intervention Description
    Parents will be educated about the home program which consisted of positioning the neck and head, sleep in alternating head positions and in side-laying to increase head shape symmetry and place infants, when awake and under supervision, regularly in the prone position a day to stimulate normal motor development (tummy time), decreasing the time spent in car seat at supine position. Environmental settings also were given to challenge the baby look through from the side no flattening to room, place colorful and sonorous toys or mirror on the opposite of the flattening side, and stimulate active rotation by communicating with baby from this side. Handling strategies, stretching and strengthening exercises will given for CMT
    Primary Outcome Measure Information:
    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 head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
    Secondary 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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    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 PhD, PT KEKLİCEK, PhD, PT
    Phone
    0903123051576
    Email
    hhotaman23@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma UYGUR, Prof,PhD
    Phone
    0903123051576
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly

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