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Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Primary Purpose

Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pediatric Manual Therapy
Educational Physical Therapy
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plagiocephaly focused on measuring Manual Therapy, Cranial assymmetry, Cranial deformation, Physical Therapy

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto deTerapias Integrativas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pediatric Manual Therapy Group

Control 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.

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.

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
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

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 wide
Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
Cranial circumference
Measured in cm with a measuring tape.

Full Information

First Posted
September 1, 2018
Last Updated
February 27, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT03659032
Brief Title
Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
Official Title
Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plagiocephaly, Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
Keywords
Manual Therapy, Cranial assymmetry, Cranial deformation, Physical Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pediatric 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
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pediatric Manual Therapy
Other Intervention Name(s)
Manual Therapy, Manual Physical Therapy
Intervention Type
Procedure
Intervention Name(s)
Educational Physical Therapy
Other Intervention Name(s)
Pediatric Physical Therapy
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
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
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
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
10 weeks
Title
Cranial circumference
Description
Measured in cm with a measuring tape.
Time Frame
10 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orosia Lucha
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Study Director
Facility Information:
Facility Name
Instituto deTerapias Integrativas
City
Zaragoza
ZIP/Postal Code
50001
Country
Spain

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
18678803
Citation
Xia JJ, Kennedy KA, Teichgraeber JF, Wu KQ, Baumgartner JB, Gateno J. Nonsurgical treatment of deformational plagiocephaly: a systematic review. Arch Pediatr Adolesc Med. 2008 Aug;162(8):719-27. doi: 10.1001/archpedi.162.8.719.
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
29617743
Citation
Kunz F, Schweitzer T, Grosse S, Wassmuth N, Stellzig-Eisenhauer A, Bohm H, Meyer-Marcotty P, Linz C. Head orthosis therapy in positional plagiocephaly: longitudinal 3D-investigation of long-term outcomes, compared with untreated infants and with a control group. Eur J Orthod. 2019 Jan 23;41(1):29-37. doi: 10.1093/ejo/cjy012.
Results Reference
background
PubMed Identifier
29394478
Citation
Ditthakasem K, Kolar JC. Deformational Plagiocephaly: A Review. Pediatr Nurs. 2017 Mar-Apr;43(2):59-64.
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
28084919
Citation
Lam S, Luerssen TG, Hadley C, Daniels B, Strickland BA, Brookshier J, Pan IW. The health belief model and factors associated with adherence to treatment recommendations for positional plagiocephaly. J Neurosurg Pediatr. 2017 Mar;19(3):282-288. doi: 10.3171/2016.9.PEDS16278. Epub 2017 Jan 13.
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
34090515
Citation
Pastor-Pons I, Lucha-Lopez MO, Barrau-Lalmolda M, Rodes-Pastor I, Rodriguez-Fernandez AL, Hidalgo-Garcia C, Tricas-Moreno JM. Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial. Ital J Pediatr. 2021 Jun 5;47(1):132. doi: 10.1186/s13052-021-01079-4.
Results Reference
derived
PubMed Identifier
33632268
Citation
Pastor-Pons I, Hidalgo-Garcia C, Lucha-Lopez MO, Barrau-Lalmolda M, Rodes-Pastor I, Rodriguez-Fernandez AL, Tricas-Moreno JM. Effectiveness of pediatric integrative manual therapy in cervical movement limitation in infants with positional plagiocephaly: a randomized controlled trial. Ital J Pediatr. 2021 Feb 25;47(1):41. doi: 10.1186/s13052-021-00995-9.
Results Reference
derived

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Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

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