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OpenTrials
Completed

NCT Number: NCT03659032

Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

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

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Key information

Conditions

Plagiocephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Plagiocephaly, Nonsynostotic Plagiocephaly, Positional

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto deTerapias Integrativas

Zaragoza, 50001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Manual Therapy

Procedure

Other names: Manual Therapy, Manual Physical Therapy

Educational Physical Therapy

Procedure

Other names: Pediatric Physical Therapy

Primary outcomes

  1. Right Oblique Cranial Vault Diameter

    Time frame: 10 weeks

    Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane

  2. Left Oblique Cranial Vault Diameter

    Time frame: 10 weeks

    Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane

Secondary outcomes

  1. Cranial length

    Time frame: 10 weeks

    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

  2. Cranial wide

    Time frame: 10 weeks

    Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.

  3. Cranial circumference

    Time frame: 10 weeks

    Measured in cm with a measuring tape.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 6, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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