Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Plagiocephaly Clinical Trial

Official title:

Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659032
• Other study ID #: PMT1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: February 2020
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Plagiocephaly, Positional

Intervention

Procedure:
• Pediatric Manual Therapy

• Educational Physical Therapy

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 (13)

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

Ditthakasem K, Kolar JC. Deformational Plagiocephaly: A Review. Pediatr Nurs. 2017 Mar-Apr;43(2):59-64. Review. — View Citation

Kunz F, Schweitzer T, Große S, Waßmuth N, Stellzig-Eisenhauer A, Böhm 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. — View 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. — 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

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

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. Review. — View Citation

* Note: There are 13 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	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	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.	10 weeks
Secondary	Cranial circumference	Measured in cm with a measuring tape.	10 weeks