Clinical trial NCT03659032: Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
Official title: Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plagiocephaly
Plagiocephaly, Nonsynostotic
Plagiocephaly, Positional
Keywords: Manual Therapy
Cranial assymmetry
Cranial deformation
Physical Therapy
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Right Oblique Cranial Vault Diameter
timeFrame: 10 weeks
measure: Left Oblique Cranial Vault Diameter
timeFrame: 10 weeks
Secondary outcomes:
measure: Cranial length
timeFrame: 10 weeks
measure: Cranial wide
timeFrame: 10 weeks
measure: Cranial circumference
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Instituto deTerapias Integrativas
Study officials:
affiliation: Universidad de Zaragoza
name: Orosia Lucha
role: STUDY_DIRECTOR
References:
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