Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly

NCT03659032 | Completed

• 1 other identifier: PMT1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Plagiocephaly; Plagiocephaly, Nonsynostotic; Plagiocephaly, Positional

Keywords

Manual Therapy; Cranial assymmetry; Cranial deformation; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  10 weeks

Secondary Outcomes (3)

• Cranial length

  10 weeks

• Cranial wide

  10 weeks

• Cranial circumference

  10 weeks

Study Arms (2)

Pediatric 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 Manual Therapy

Control Group

ACTIVE COMPARATOR

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.

Procedure: Educational Physical Therapy

Interventions

Pediatric Manual Therapy PROCEDURE

Also known as: Manual Therapy, Manual Physical Therapy

Pediatric Manual Therapy Group

Educational Physical Therapy PROCEDURE

Also known as: Pediatric Physical Therapy

Control Group

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Sign of positional plagiocephaly
• Infants below 6 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

Location

Related Publications (15)

• 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

• 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.

  PMID: 18678803 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

• 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.

  PMID: 29617743 BACKGROUND

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

  PMID: 29394478 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

• 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.

  PMID: 28084919 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

• 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.

  PMID: 34090515 DERIVED

• 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.

  PMID: 33632268 DERIVED

MeSH Terms

Conditions

Plagiocephaly; Plagiocephaly, Nonsynostotic

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Orosia Lucha

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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: Researcher at PhD School

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: September 6, 2018
• Study Start: January 1, 2017
• Primary Completion: July 30, 2019
• Study Completion: January 10, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)