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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cranial length |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iñaki Pastor Pons | Contact | +34657272757 | inakipas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Orosia Lucha | Universidad de Zaragoza | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto deTerapias Integrativas | Recruiting | Zaragoza | 50001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29072040 | Background | 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. | |
| 27465676 | 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. |
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Parallel assignment
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Double (Investigator, Outcomes Assessor) The assessors who receive participants and do the measurement are masked
|
| 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. |
|
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 |
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 |
| 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 |
| 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 |
| Cranial maximal circumference | Measured in cm with a measuring tape. | 4 weeks |
| Cranial maximal circumference | Measured in cm with a measuring tape. | 10 weeks |
| 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 |
| 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 |
| 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 |
| 27603533 | 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. |
| 30030600 | 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. |
| 29372872 | 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. |
| 29137851 | 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. |
| 27815732 | 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. |
| 25823758 | 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. |
| 28104626 | 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. |
| 21568831 | 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. |
| 21145518 | 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. |
| 19212900 | 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. |
| 31232996 | 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. |
| 27940801 | 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. |
| ID | Term |
|---|---|
| D049068 | Plagiocephaly, Nonsynostotic |
| C535425 | Congenital torticollis |
| ID | Term |
|---|---|
| D059041 | Plagiocephaly |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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