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

Congenital Muscular Torticollis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672837
• Other study ID #: PMT2
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: Universidad de Zaragoza
• Contact: Iñaki Pastor Pons
• Phone: +34657272757
• Email: inakipas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Muscular Torticollis
• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Plagiocephaly, Positional
• Torticollis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Instituto deTerapias Integrativas	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (14)

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. — View 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. Review. — View 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. — View Citation

Billi M, Greco A, Colonneli P, Volpi G, Valente D, Galeoto G. The functional manual therapy intervention in infants with nonsynostotic plagiocephaly: a pilot study. Minerva Pediatr. 2017 Oct 25. doi: 10.23736/S0026-4946.17.04838-1. [Epub ahead of print] — View Citation

Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benítez-Feliponi A, Robles-Vizcaíno 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. Epub 2016 Jul 27. — View 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. Review. — View 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. — View 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. — View Citation

Ohman A, Mårdbrink 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. — View 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. — View 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. — View Citation

Systematic Review and Evidence-Based Guidelines for the Management of Patients with Positional Plagiocephaly. Pediatrics. 2016 Nov;138(5). pii: e20162802. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Active Cervical Rotation Range of movement	Measured with photographs and digital angular analysis	4 weeks
Primary	Active Cervical Rotation Range of movement	Measured with digital angular analysis	10 weeks
Primary	Passive Cervical Rotation Range of movement	Measured lying down with joint goniometer	4 weeks
Primary	Passive Cervical Rotation Range of movement	Measured lying down with joint goniometer	10 weeks
Primary	Passive Cervical Lateral Flexion Range of movement	Measured lying down with joint goniometer	4 weeks
Primary	Passive Cervical Lateral Flexion Range of movement	Measured lying down with joint goniometer	10 weeks
Primary	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
Primary	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	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	4 weeks and 10 weeks
Secondary	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	10 weeks
Secondary	Cranial wide	Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.	4 weeks
Secondary	Cranial wide	Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.	10 weeks
Secondary	Cranial maximal circumference	Measured in cm with a measuring tape.	4 weeks
Secondary	Cranial maximal circumference	Measured in cm with a measuring tape.	10 weeks
Secondary	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.	10 weeks
Secondary	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.	10 weeks
Secondary	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	10 weeks