Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

February 27, 2020 updated by: Iñaki Pastor Pons, Universidad de Zaragoza
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50001
        • Instituto deTerapias Integrativas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pediatric Manual Therapy Group
10 sessions of Pediatric Manual Therapy, once a week. Soft cervical mobilisation, myofascial induction and cranial techniques will be administered. Educational physiotherapy consists in "tummy time" stimulation, visual and kinaesthetic stimulation on the non preferential head position and counter position will be also administered.
Procedure: Pediatric Manual Therapy
Other Names:
  • Manual Therapy
  • Manual Physical Therapy
ACTIVE_COMPARATOR: Control Group
Only Educational Physical Therapy consists in "tummy time" stimulation, visual and kinaesthetic stimulation on the non preferential head position and counter position will be administered.
Procedure: Educational Physical Therapy
Other Names:
  • Pediatric Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 weeks
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
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 weeks
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.
10 weeks
Cranial circumference
Time Frame: 10 weeks
Measured in cm with a measuring tape.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Zaragoza

Investigators

  • Study Director: Orosia Lucha, Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

July 30, 2019

Study Completion (ACTUAL)

January 10, 2020

Study Registration Dates

First Submitted

September 1, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (ACTUAL)

September 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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