Efficacy of Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
| Registry | NCT04672837 |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 50 (Estimated) |
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| Sponsor | Universidad de Zaragoza (Other) |
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| Conditions | Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Congenital Muscular Torticollis |
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| Interventions | Pediatric Integrative Manual Therapy and educational therapy, Stretching and educational therapy (Procedure) |
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| Dates | start 2019-06-01, primary completion 2023-05-30 (estimated), completion 2023-06-30 (estimated), first posted 2020-12-17, last updated 2022-05-20 |
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| Locations | 1 site in Spain |
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Related Papers Related Patents Related Grants Related Experts
All trials for Plagiocephaly, Nonsynostotic All trials for Plagiocephaly, Positional All trials of Pediatric Integrative Manual Therapy and educational therapy All trials of Stretching and educational therapy
-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
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+Detailed 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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Manual Therapy Group | Experimental | Procedure: Pediatric Integrative Manual Therapy and educational therapy | 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. |
| Stretching Group | Active comparator | Procedure: Stretching and educational therapy | 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. |
- 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.
- 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.
+Outcome measures
Primary outcomes
- Right Oblique Cranial Vault Diameter [4 weeks]: Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
- Right Oblique Cranial Vault Diameter [10 weeks]: Measured with caliper, is the distance from left external part of the orbit to the right lambdoid suture at the horizontal plane
- Left Oblique Cranial Vault Diameter [4 weeks]: Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
- Left Oblique Cranial Vault Diameter [10 weeks]: Measured with caliper, is the distance from right external part of the orbit to the left lambdoid suture at the horizontal plane
- Active Cervical Rotation Range of movement [4 weeks]: Measured with photographs and digital angular analysis
- Active Cervical Rotation Range of movement [10 weeks]: Measured with digital angular analysis
- Passive Cervical Rotation Range of movement [4 weeks]: Measured lying down with joint goniometer
- Passive Cervical Rotation Range of movement [10 weeks]: Measured lying down with joint goniometer
- Passive Cervical Lateral Flexion Range of movement [4 weeks]: Measured lying down with joint goniometer
- Passive Cervical Lateral Flexion Range of movement [10 weeks]: Measured lying down with joint goniometer
- Muscle Function Test [4 weeks]: Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
- Muscle Function Test [10 weeks]: Measured in lateral suspension giving a value of 0 to 5 according to the alignment of the head with the trunk
Secondary outcomes
- Cranial length [4 weeks and 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
- Cranial length [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
- Cranial wide [4 weeks]: Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
- Cranial wide [10 weeks]: Measured with calliper, is the distance between the two more lateral points in the vault, usually in the temporal or parietal bone.
- Cranial maximal circumference [4 weeks]: Measured in cm with a measuring tape.
- Cranial maximal circumference [10 weeks]: Measured in cm with a measuring tape.
- Alberta Infant Motor Scale [10 weeks]: 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.
- Visual Analogical Scale about improvement in cervical movement after intervention [10 weeks]: 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.
- Visual Analogical Scale about improvement in cranial asymmetry after intervention [10 weeks]: 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
+Eligibility
Sex: All, ages: 0 Months to 12 Months
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
+Locations (1)
| Facility | City | Country | Status |
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| Instituto deTerapias Integrativas | Zaragoza | Spain | Recruiting |
+Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
+Investigators