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Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Sponsor
Universidad de Zaragoza (Other)
Overall Status
Completed
CT.gov ID
NCT03659032
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
36.3
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pediatric Manual Therapy
  • Procedure: Educational Physical Therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel assignmentParallel assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The assessors who receive participants and do the measurement are masked
Primary Purpose:
Treatment
Official Title:
Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 30, 2019
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Right Oblique Cranial Vault Diameter [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 [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 Outcome Measures

    1. Cranial length [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 [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 [10 weeks]

      Measured in cm with a measuring tape.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto deTerapias Integrativas Zaragoza Spain 50001

    Sponsors and Collaborators

    • Universidad de Zaragoza

    Investigators

    • Study Director: Orosia Lucha, Universidad de Zaragoza

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Iñaki Pastor Pons, Researcher at PhD School, Universidad de Zaragoza
    ClinicalTrials.gov Identifier:
    NCT03659032
    Other Study ID Numbers:
    • PMT1
    First Posted:
    Sep 6, 2018
    Last Update Posted:
    Mar 3, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Iñaki Pastor Pons, Researcher at PhD School, Universidad de Zaragoza
    Manual Therapy
    Cranial assymmetry
    Cranial deformation
    Physical Therapy
    Additional relevant MeSH terms:
    Plagiocephaly
    Plagiocephaly, Nonsynostotic

    Study Results

    No Results Posted as of Mar 3, 2020