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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis

Conditions
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Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Congenital Muscular Torticollis

Intervention / Treatment
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* Procedure: Pediatric Integrative Manual Therapy and educational therapy
* Procedure: Stretching and educational therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy Group<br>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. | Procedure: Pediatric Integrative Manual Therapy and educational therapy<br>* Pediatric Integrative Manual Therapy is a soft Orthopedic Manual Therapy approach por infants and children. It integrates joints soft mobilisation, myofascial release and neurodynamic mobilisation. Also the educational therapy.<br>|
| Active Comparator: Stretching Group<br>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. | Procedure: Stretching and educational therapy<br>* It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right Oblique Cranial Vault Diameter | Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane | 4 weeks | 
| Right Oblique Cranial Vault Diameter | Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane | 10 weeks | 
| Left Oblique Cranial Vault Diameter | Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane | 4 weeks | 
| Left Oblique Cranial Vault Diameter | Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane | 10 weeks | 
| Active Cervical Rotation Range of movement | Measured with photographs and digital angular analysis | 4 weeks | 
| Active Cervical Rotation Range of movement | Measured with digital angular analysis | 10 weeks | 
| Passive Cervical Rotation Range of movement | Measured lying down with joint goniometer | 4 weeks | 
| Passive Cervical Rotation Range of movement | Measured lying down with joint goniometer | 10 weeks | 
| Passive Cervical Lateral Flexion Range of movement | Measured lying down with joint goniometer | 4 weeks | 
| Passive Cervical Lateral Flexion Range of movement | Measured lying down with joint goniometer | 10 weeks | 
| Muscle Function Test | Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk | 4 weeks | 
| Muscle Function Test | Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cranial length | 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 | 4 weeks and 10 weeks | 
| Cranial length | 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 | 10 weeks | 
| Cranial wide | Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone. | 4 weeks | 
| Cranial wide | Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone. | 10 weeks | 
| Cranial maximal circumference | Measured in cm with a measuring tape. | 4 weeks | 
| Cranial maximal circumference | Measured in cm with a measuring tape. | 10 weeks | 
| Alberta Infant Motor Scale | 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. | 10 weeks | 
| Visual Analogical Scale about improvement in cervical movement after intervention | 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. | 10 weeks | 
| Visual Analogical Scale about improvement in cranial asymmetry after intervention | 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 | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual Therapy, Physical Therapy, Cranial Asymmetry, Preferential position of the head