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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04672837
Enrollment
50
Registered
2020-12-17
Start date
2019-06-01
Completion date
2023-06-30
Last updated
2022-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Muscular Torticollis, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional

Keywords

Manual Therapy, Physical Therapy, Cranial Asymmetry, Preferential position of the head

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.

Interventions

PROCEDUREPediatric Integrative Manual Therapy and educational therapy

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.

PROCEDUREStretching and educational therapy

It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Double (Investigator, Outcomes Assessor) The assessors who receive participants and do the measurement are masked

Intervention model description

Parallel assignment

Eligibility

Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle Function Test4 weeksMeasured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Right Oblique Cranial Vault Diameter4 weeksMeasured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Left Oblique Cranial Vault Diameter4 weeksMeasured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Active Cervical Rotation Range of movement4 weeksMeasured with photographs and digital angular analysis
Passive Cervical Rotation Range of movement4 weeksMeasured lying down with joint goniometer
Passive Cervical Lateral Flexion Range of movement4 weeksMeasured lying down with joint goniometer

Secondary

MeasureTime frameDescription
Cranial length4 weeks and 10 weeksMeasured 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
Cranial wide4 weeksMeasured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Cranial maximal circumference4 weeksMeasured in cm with a measuring tape.
Alberta Infant Motor Scale10 weeksNeuromotor 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 intervention10 weeksParents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the cervical movement.
Visual Analogical Scale about improvement in cranial asymmetry after intervention10 weeksParents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the head shape

Countries

Spain

Contacts

Primary ContactIñaki Pastor Pons
inakipas@gmail.com+34657272757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026