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

May 19, 2022 updated by: Iñaki Pastor Pons, Universidad de Zaragoza

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

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

Study Overview

Status

Recruiting

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. 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.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

Study Locations

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

1 second to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 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.
Active Comparator: Stretching Group

A protocol of Stretching at home. 3-5 sessions twice a day. Each stretch will be maintain10 to 30 seconds. Each session 15 will take no less than 15 minutes. 7 days a week.

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: Stretching 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right Oblique Cranial Vault Diameter
Time Frame: 4 weeks
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
4 weeks
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: 4 weeks
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
4 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
Active Cervical Rotation Range of movement
Time Frame: 4 weeks
Measured with photographs and digital angular analysis
4 weeks
Active Cervical Rotation Range of movement
Time Frame: 10 weeks
Measured with digital angular analysis
10 weeks
Passive Cervical Rotation Range of movement
Time Frame: 4 weeks
Measured lying down with joint goniometer
4 weeks
Passive Cervical Rotation Range of movement
Time Frame: 10 weeks
Measured lying down with joint goniometer
10 weeks
Passive Cervical Lateral Flexion Range of movement
Time Frame: 4 weeks
Measured lying down with joint goniometer
4 weeks
Passive Cervical Lateral Flexion Range of movement
Time Frame: 10 weeks
Measured lying down with joint goniometer
10 weeks
Muscle Function Test
Time Frame: 4 weeks
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
4 weeks
Muscle Function Test
Time Frame: 10 weeks
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cranial length
Time Frame: 4 weeks and 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
4 weeks and 10 weeks
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: 4 weeks
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
4 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 maximal circumference
Time Frame: 4 weeks
Measured in cm with a measuring tape.
4 weeks
Cranial maximal circumference
Time Frame: 10 weeks
Measured in cm with a measuring tape.
10 weeks
Alberta Infant Motor Scale
Time Frame: 10 weeks
Neuromotor 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.
10 weeks
Visual Analogical Scale about improvement in cervical movement after intervention
Time Frame: 10 weeks
Parents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the cervical movement.
10 weeks
Visual Analogical Scale about improvement in cranial asymmetry after intervention
Time Frame: 10 weeks
Parents perception of changes in their baby. Minimum value -10; maximum value +10. Higher scores indicate a better perception of change in the head shape
10 weeks

Collaborators and Investigators

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

Sponsor

Universidad de Zaragoza

Investigators

  • Study Chair: 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)

June 1, 2019

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMT2

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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