Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly
Comparison the Effectiveness Control Frequency of Physiotherapy Home Program on Deformational Plagiocephaly
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 18, 2015
November 1, 2015
4 months
November 16, 2015
November 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plagiocephaly severity scale
scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry.
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 Outcomes (1)
Head tilt with photographic method
Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
Study Arms (2)
seen once every six weeks
EXPERIMENTALParents will be educated about home program and they will be asked to control once every six weeks.
seen once a week.
EXPERIMENTALParents will be educated about home program and they will be asked to control once a week.
Interventions
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
Eligibility Criteria
You may qualify if:
- Babies with congenital muscular torticollis and secondary deformational plagiocephaly
- Head tilt from 5 to 20 degrees
- Age between 0-6 months
You may not qualify if:
- Have another health problem such as neurological, vertebral anomalies, craniosynostosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hilal KEKLİCEK, PhD, PT
Hacettepe University,Faculty of Health Sciences Department of Physiotherapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, PT
Study Record Dates
First Submitted
November 16, 2015
First Posted
November 18, 2015
Study Start
November 1, 2015
Primary Completion
March 1, 2016
Study Completion
November 1, 2016
Last Updated
November 18, 2015
Record last verified: 2015-11