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Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03659032
Enrollment
60
Registered
2018-09-06
Start date
2017-01-01
Completion date
2020-01-10
Last updated
2020-03-03

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

Conditions

Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional

Keywords

Manual Therapy, Cranial assymmetry, Cranial deformation, Physical Therapy

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.

Interventions

PROCEDUREPediatric Manual Therapy
PROCEDUREEducational Physical Therapy

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

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

Masking description

The assessors who receive participants and do the measurement are masked

Intervention model description

Parallel assignment

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Right Oblique Cranial Vault Diameter10 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 Diameter10 weeksMeasured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane

Secondary

MeasureTime frameDescription
Cranial circumference10 weeksMeasured in cm with a measuring tape.
Cranial length10 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 wide10 weeksMeasured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026