Clinical trial NCT04672837: Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
Official title: Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plagiocephaly, Nonsynostotic
Plagiocephaly, Positional
Congenital Muscular Torticollis
Keywords: Manual Therapy
Physical Therapy
Cranial Asymmetry
Preferential position of the head
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Right Oblique Cranial Vault Diameter
timeFrame: 4 weeks
measure: Right Oblique Cranial Vault Diameter
timeFrame: 10 weeks
measure: Left Oblique Cranial Vault Diameter
timeFrame: 4 weeks
measure: Left Oblique Cranial Vault Diameter
timeFrame: 10 weeks
measure: Active Cervical Rotation Range of movement
timeFrame: 4 weeks
measure: Active Cervical Rotation Range of movement
timeFrame: 10 weeks
measure: Passive Cervical Rotation Range of movement
timeFrame: 4 weeks
measure: Passive Cervical Rotation Range of movement
timeFrame: 10 weeks
measure: Passive Cervical Lateral Flexion Range of movement
timeFrame: 4 weeks
measure: Passive Cervical Lateral Flexion Range of movement
timeFrame: 10 weeks
measure: Muscle Function Test
timeFrame: 4 weeks
measure: Muscle Function Test
timeFrame: 10 weeks
Secondary outcomes:
measure: Cranial length
timeFrame: 4 weeks and 10 weeks
measure: Cranial length
timeFrame: 10 weeks
measure: Cranial wide
timeFrame: 4 weeks
measure: Cranial wide
timeFrame: 10 weeks
measure: Cranial maximal circumference
timeFrame: 4 weeks
measure: Cranial maximal circumference
timeFrame: 10 weeks
measure: Alberta Infant Motor Scale
timeFrame: 10 weeks
measure: Visual Analogical Scale about improvement in cervical movement after intervention
timeFrame: 10 weeks
measure: Visual Analogical Scale about improvement in cranial asymmetry after intervention
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_CHAIR
References:
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