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

NCT04672837 | Unknown

• 1 other identifier: PMT2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Plagiocephaly, Nonsynostotic; Plagiocephaly, Positional; Congenital Muscular Torticollis

Keywords

Manual Therapy; Physical Therapy; Cranial Asymmetry; Preferential position of the head

Outcome Measures

Primary Outcomes (12)

• 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

  4 weeks

• 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

  10 weeks

• 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

  4 weeks

• 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

  10 weeks

• Active Cervical Rotation Range of movement

  Measured with photographs and digital angular analysis

  4 weeks

• Active Cervical Rotation Range of movement

  Measured with digital angular analysis

  10 weeks

• Passive Cervical Rotation Range of movement

  Measured lying down with joint goniometer

  4 weeks

• Passive Cervical Rotation Range of movement

  Measured lying down with joint goniometer

  10 weeks

• Passive Cervical Lateral Flexion Range of movement

  Measured lying down with joint goniometer

  4 weeks

• Passive Cervical Lateral Flexion Range of movement

  Measured lying down with joint goniometer

  10 weeks

• Muscle Function Test

  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

  Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk

  10 weeks

Secondary Outcomes (9)

• Cranial length

  4 weeks and 10 weeks

• Cranial length

  10 weeks

• Cranial wide

  4 weeks

• Cranial wide

  10 weeks

• Cranial maximal circumference

  4 weeks

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL

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

Stretching Group

ACTIVE COMPARATOR

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

Interventions

Pediatric Integrative Manual Therapy and educational therapy PROCEDURE

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.

Manual Therapy Group

Stretching and educational therapy PROCEDURE

It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.

Stretching Group

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sign of positional plagiocephaly
• Infants below 12 moths age

You may not qualify if:

• No neurological disorders
• No infectious diseases
• No respiratory diseases
• No other treatments

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Instituto deTerapias Integrativas

Zaragoza, 50001, Spain

RECRUITING

Related Publications (14)

• 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.

  PMID: 29072040 BACKGROUND

• 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.

  PMID: 27465676 BACKGROUND

• 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.

  PMID: 27603533 BACKGROUND

• 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.

  PMID: 30030600 BACKGROUND

• 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.

  PMID: 29372872 BACKGROUND

• 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.

  PMID: 29137851 BACKGROUND

• 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.

  PMID: 27815732 BACKGROUND

• 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.

  PMID: 25823758 BACKGROUND

• 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.

  PMID: 28104626 BACKGROUND

• 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.

  PMID: 21568831 BACKGROUND

• 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.

  PMID: 21145518 BACKGROUND

• 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.

  PMID: 19212900 BACKGROUND

• 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.

  PMID: 31232996 BACKGROUND

• 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.

  PMID: 27940801 BACKGROUND

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic; Congenital torticollis

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Orosia Lucha

  Universidad de Zaragoza

  STUDY CHAIR

Central Study Contacts

Iñaki Pastor Pons

CONTACT

+34657272757; inakipas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Investigator, Outcomes Assessor) The assessors who receive participants and do the measurement are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator at Manual Therapy Research Unit

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2019
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)