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
About this trial
This is an interventional treatment trial for Deformational Plagiocephaly focused on measuring Deformational Plagiocephaly,Treatment,Compliance
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
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
NCT ID
NCT02607969
First Posted
November 16, 2015
Last Updated
November 16, 2015
Sponsor
Hacettepe University
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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