Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis

Not Applicable

• Conditions: Congenital Muscular Torticollis; Plagiocephaly, Positional; Plagiocephaly, Nonsynostotic
• Interventions: Procedure: Pediatric Integrative Manual Therapy and educational therapy; Procedure: Stretching and educational therapy

• Registration Number: NCT04672837
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

This study evaluates the efficacy of Pediatric Integrative Manual Therapy in the treatment of positional plagiocephaly in infants. 25 participants will receive a protocol of Pediatric Integrative Manual Therapy and educational physiotherapy in combination, while the other 25 will receive a stretching protocol and 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. When babies present preferential position of the head or Congenital Muscular Torticollis, stretching has shown efficacy.

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 a protocol of stretching at home done by their parents and Educational therapy.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Sign of positional plagiocephaly
• Infants below 12 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
Manual Therapy Group	Pediatric Integrative Manual Therapy and educational 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.
Stretching Group	Stretching and educational therapy	A protocol of Stretching at home. 3-5 sessions twice a day. Each stretch will be maintain10 to 30 seconds. Each session 15 will take no less than 15 minutes. 7 days a week. 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
Passive Cervical Lateral Flexion Range of movement	10 weeks	Measured lying down with joint goniometer
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
Active Cervical Rotation Range of movement	10 weeks	Measured with digital angular analysis
Passive Cervical Rotation Range of movement	10 weeks	Measured lying down with joint goniometer
Muscle Function Test	10 weeks	Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
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

Secondary Outcome Measures

Name	Time	Method
Cranial maximal circumference	10 weeks	Measured in cm with a measuring tape.
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.
Alberta Infant Motor Scale	10 weeks	Neuromotor scale for infants from 0 to 14 months. Maximum value 90th; minimum value 0th. Higher scores indicate a better motor and postural development. Values below 15th indicate risk of development delay.
Visual Analogical Scale about improvement in cervical movement after intervention	10 weeks	Parents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the cervical movement.
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
Visual Analogical Scale about improvement in cranial asymmetry after intervention	10 weeks	Parents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the head shape

Trial Locations

Locations (1)

Instituto deTerapias Integrativas; 🇪🇸 Zaragoza, Spain