Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Not Applicable

Completed

• Conditions: Plagiocephaly, Nonsynostotic; Plagiocephaly; Plagiocephaly, Positional
• Interventions: Procedure: Pediatric Manual Therapy; Procedure: Educational Physical Therapy

• Registration Number: NCT03659032
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

This study evaluates the efficacy of Pediatric Manual Therapy in the treatment of positional plagiocephaly in infants. 40 participants will receive a protocol of Pediatric Manual Therapy and educational physiotherapy in combination, while the other 20 will receive only educational physiotherapy

Detailed Description

The Manual Therapy has shown efficacy in different pathologies in the adult but it is not know its utility in infants and children population, nor in specific pathologies as non synostotic plagiocephaly.

In the conservative treatment of plagiocephaly the educational physiotherapy and the helmet therapy have the better level of evidence among other treatments.

A protocol of ten sessions of Pediatric Manual Therapy will be applied to infants with positional plagiocephaly in combination with educational physiotherapy. The protocol consists in soft cervical mobilisation, myofascial induction and the application of some pressures to the cranial bones to improve the asymmetry of the head. Educational therapy which consists in more "tummy time" stimulation, stimulation to the non preference position of the head and counter positioning.

The control group will receive only Educational therapy.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-09-01
• Study First Submitted QC: 2018-09-01
• Study First Posted: 2018-09-06
• Primary Completion: 2019-07-30
• Study Completion: 2020-01-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Sign of positional plagiocephaly
• Infants below 6 moths age

Exclusion Criteria

• No neurological disorders
• No infectious diseases
• No respiratory diseases
• No other treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric Manual Therapy Group	Pediatric Manual Therapy	10 sessions of Pediatric Manual Therapy, once a week. Soft cervical mobilisation, myofascial induction and cranial techniques will be administered. Educational physiotherapy consists in "tummy time" stimulation, visual and kinaesthetic stimulation on the non preferential head position and counter position will be also administered.
Control Group	Educational Physical Therapy	Only Educational Physical Therapy consists in "tummy time" stimulation, visual and kinaesthetic stimulation on the non preferential head position and counter position will be administered.

Primary Outcome Measures

Name	Time	Method
Left Oblique Cranial Vault Diameter	10 weeks	Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Right Oblique Cranial Vault Diameter	10 weeks	Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane

Secondary Outcome Measures

Name	Time	Method
Cranial circumference	10 weeks	Measured in cm with a measuring tape.
Cranial length	10 weeks	Measured with calliper, is the distance from most anterior point in the frontal bone in the middle line to the most posterior point in the cranial vault on the horizontal plane in the middle line
Cranial wide	10 weeks	Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.

Trial Locations

Locations (1)

Instituto deTerapias Integrativas; 🇪🇸 Zaragoza, Spain