search
Back to results

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

Primary Purpose

Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Congenital Muscular Torticollis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pediatric Integrative Manual Therapy and educational therapy
Stretching and educational therapy
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plagiocephaly, Nonsynostotic focused on measuring Manual Therapy, Physical Therapy, Cranial Asymmetry, Preferential position of the head

Eligibility Criteria

0 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto deTerapias IntegrativasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy Group

Stretching Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cranial length
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
Cranial length
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
Cranial wide
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Cranial wide
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Cranial maximal circumference
Measured in cm with a measuring tape.
Cranial maximal circumference
Measured in cm with a measuring tape.
Alberta Infant Motor Scale
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.
Visual Analogical Scale about improvement in cervical movement after intervention
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.
Visual Analogical Scale about improvement in cranial asymmetry after intervention
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

Full Information

First Posted
December 2, 2020
Last Updated
May 19, 2022
Sponsor
Universidad de Zaragoza
search

1. Study Identification

Unique Protocol Identification Number
NCT04672837
Brief Title
Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
Official Title
Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Congenital Muscular Torticollis
Keywords
Manual Therapy, Physical Therapy, Cranial Asymmetry, Preferential position of the head

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Double (Investigator, Outcomes Assessor) The assessors who receive participants and do the measurement are masked
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pediatric Integrative Manual Therapy and educational therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stretching and educational therapy
Intervention Description
It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.
Primary Outcome Measure Information:
Title
Right Oblique Cranial Vault Diameter
Description
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Time Frame
4 weeks
Title
Right Oblique Cranial Vault Diameter
Description
Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
Time Frame
10 weeks
Title
Left Oblique Cranial Vault Diameter
Description
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Time Frame
4 weeks
Title
Left Oblique Cranial Vault Diameter
Description
Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
Time Frame
10 weeks
Title
Active Cervical Rotation Range of movement
Description
Measured with photographs and digital angular analysis
Time Frame
4 weeks
Title
Active Cervical Rotation Range of movement
Description
Measured with digital angular analysis
Time Frame
10 weeks
Title
Passive Cervical Rotation Range of movement
Description
Measured lying down with joint goniometer
Time Frame
4 weeks
Title
Passive Cervical Rotation Range of movement
Description
Measured lying down with joint goniometer
Time Frame
10 weeks
Title
Passive Cervical Lateral Flexion Range of movement
Description
Measured lying down with joint goniometer
Time Frame
4 weeks
Title
Passive Cervical Lateral Flexion Range of movement
Description
Measured lying down with joint goniometer
Time Frame
10 weeks
Title
Muscle Function Test
Description
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Time Frame
4 weeks
Title
Muscle Function Test
Description
Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Cranial length
Description
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
Time Frame
4 weeks and 10 weeks
Title
Cranial length
Description
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
Time Frame
10 weeks
Title
Cranial wide
Description
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Time Frame
4 weeks
Title
Cranial wide
Description
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Time Frame
10 weeks
Title
Cranial maximal circumference
Description
Measured in cm with a measuring tape.
Time Frame
4 weeks
Title
Cranial maximal circumference
Description
Measured in cm with a measuring tape.
Time Frame
10 weeks
Title
Alberta Infant Motor Scale
Description
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.
Time Frame
10 weeks
Title
Visual Analogical Scale about improvement in cervical movement after intervention
Description
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.
Time Frame
10 weeks
Title
Visual Analogical Scale about improvement in cranial asymmetry after intervention
Description
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
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iñaki Pastor Pons
Phone
+34657272757
Email
inakipas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orosia Lucha
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto deTerapias Integrativas
City
Zaragoza
ZIP/Postal Code
50001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iñaki Pastor Pons
Phone
+34657272757
Email
inakipas@gmail.com
First Name & Middle Initial & Last Name & Degree
Elena Lecha
Phone
+34 976284470
Email
elena@itifisioterapia.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29072040
Citation
Billi M, Greco A, Colonneli P, Volpi G, Valente D, Galeoto G. The functional manual therapy intervention in infants with non-synostotic plagiocephaly: a pilot study. Minerva Pediatr (Torino). 2022 Jun;74(3):294-300. doi: 10.23736/S2724-5276.17.04838-1. Epub 2017 Oct 25.
Results Reference
background
PubMed Identifier
27465676
Citation
Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benitez-Feliponi A, Robles-Vizcaino C, Ruiz-Extremera A. Effects of manual therapy on treatment duration and motor development in infants with severe nonsynostotic plagiocephaly: a randomised controlled pilot study. Childs Nerv Syst. 2016 Nov;32(11):2211-2217. doi: 10.1007/s00381-016-3200-5. Epub 2016 Jul 27.
Results Reference
background
PubMed Identifier
27603533
Citation
Bagagiolo D, Didio A, Sbarbaro M, Priolo CG, Borro T, Farina D. Osteopathic Manipulative Treatment in Pediatric and Neonatal Patients and Disorders: Clinical Considerations and Updated Review of the Existing Literature. Am J Perinatol. 2016 Sep;33(11):1050-4. doi: 10.1055/s-0036-1586113. Epub 2016 Sep 7.
Results Reference
background
PubMed Identifier
30030600
Citation
Ballardini E, Sisti M, Basaglia N, Benedetto M, Baldan A, Borgna-Pignatti C, Garani G. Prevalence and characteristics of positional plagiocephaly in healthy full-term infants at 8-12 weeks of life. Eur J Pediatr. 2018 Oct;177(10):1547-1554. doi: 10.1007/s00431-018-3212-0. Epub 2018 Jul 20.
Results Reference
background
PubMed Identifier
29372872
Citation
Williams E. Preventing "Flat-headed" Babies: A Commentary on "Impact of Parent Practices of Infant Positioning on Head Orientation Profile and Development of Positional Plagiocephaly in Healthy Term Infants". Phys Occup Ther Pediatr. 2018 Feb;38(1):15-17. doi: 10.1080/01942638.2018.1405661. No abstract available.
Results Reference
background
PubMed Identifier
29137851
Citation
Nahles S, Klein M, Yacoub A, Neyer J. Evaluation of positional plagiocephaly: Conventional anthropometric measurement versus laser scanning method. J Craniomaxillofac Surg. 2018 Jan;46(1):11-21. doi: 10.1016/j.jcms.2017.10.010. Epub 2017 Oct 16.
Results Reference
background
PubMed Identifier
27815732
Citation
van Vlimmeren LA, Engelbert RH, Pelsma M, Groenewoud HM, Boere-Boonekamp MM, der Sanden MW. The course of skull deformation from birth to 5 years of age: a prospective cohort study. Eur J Pediatr. 2017 Jan;176(1):11-21. doi: 10.1007/s00431-016-2800-0. Epub 2016 Nov 4.
Results Reference
background
PubMed Identifier
25823758
Citation
Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Preventing deformational plagiocephaly through parent guidance: a randomized, controlled trial. Eur J Pediatr. 2015 Sep;174(9):1197-208. doi: 10.1007/s00431-015-2520-x. Epub 2015 Apr 1.
Results Reference
background
PubMed Identifier
28104626
Citation
De Bock F, Braun V, Renz-Polster H. Deformational plagiocephaly in normal infants: a systematic review of causes and hypotheses. Arch Dis Child. 2017 Jun;102(6):535-542. doi: 10.1136/archdischild-2016-312018. Epub 2017 Jan 19.
Results Reference
background
PubMed Identifier
21568831
Citation
Ohman A, Mardbrink EL, Stensby J, Beckung E. Evaluation of treatment strategies for muscle function in infants with congenital muscular torticollis. Physiother Theory Pract. 2011 Oct;27(7):463-70. doi: 10.3109/09593985.2010.536305. Epub 2011 May 15.
Results Reference
background
PubMed Identifier
21145518
Citation
Ohman A, Nilsson S, Beckung E. Stretching treatment for infants with congenital muscular torticollis: physiotherapist or parents? A randomized pilot study. PM R. 2010 Dec;2(12):1073-9. doi: 10.1016/j.pmrj.2010.08.008.
Results Reference
background
PubMed Identifier
19212900
Citation
Ohman AM, Nilsson S, Beckung ER. Validity and reliability of the muscle function scale, aimed to assess the lateral flexors of the neck in infants. Physiother Theory Pract. 2009 Feb;25(2):129-37. doi: 10.1080/09593980802686904.
Results Reference
background
PubMed Identifier
31232996
Citation
Di Chiara A, La Rosa E, Ramieri V, Vellone V, Cascone P. Treatment of Deformational Plagiocephaly With Physiotherapy. J Craniofac Surg. 2019 Oct;30(7):2008-2013. doi: 10.1097/SCS.0000000000005665.
Results Reference
background
PubMed Identifier
27940801
Citation
Systematic Review and Evidence-Based Guidelines for the Management of Patients with Positional Plagiocephaly. Pediatrics. 2016 Nov;138(5):e20162802. doi: 10.1542/peds.2016-2802. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs