Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Conditions
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Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional

Intervention / Treatment
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* Procedure: Pediatric Manual Therapy
* Procedure: Educational Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Pediatric 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 Manual Therapy<br> <br> * Other names: Manual Physical Therapy;|
| Active Comparator: Control Group<br>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. | Procedure: Educational Physical Therapy<br> <br> * Other names: Pediatric Physical Therapy;|

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 | 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 | 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 | 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. | 10 weeks | 
| Cranial circumference | Measured in cm with a measuring tape. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual Therapy, Cranial assymmetry, Cranial deformation, Physical Therapy