Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly

Deformational Plagiocephaly Clinical Trial

Official title:

Comparison the Effectiveness Control Frequency of Physiotherapy Home Program on Deformational Plagiocephaly

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02607969
• Other study ID #: G014/15
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2015
• Last updated: November 16, 2015
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2015
• Source: Hacettepe University
• Contact: Hilal PhD, PT KEKLICEK, PhD, PT
• Phone: 0903123051576
• Email: hhotaman23[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deformational Plagiocephaly
• Plagiocephaly
• Plagiocephaly, Nonsynostotic

Intervention

Other:
• Home program
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks	Yes