Efficacy of Pediatric Manual Therapy in the Positional Plagiocephaly
NCT ID: NCT03659032
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2017-01-01
2020-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pediatric Integrative Manual Therapy in Babies With Deformational Plagiocephaly and Congenital Muscular Torticollis
NCT04672837
Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course
NCT06173102
Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly
NCT02607969
The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Spastic Diplegia Cerebral Palsy
NCT05198921
Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies
NCT05313295
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pediatric Manual Therapy Group
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.
Pediatric Manual Therapy
Control Group
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.
Educational Physical Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pediatric Manual Therapy
Educational Physical Therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Infants below 6 moths age
Exclusion Criteria
* No infectious diseases
* No respiratory diseases
* No other treatments
6 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Zaragoza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Iñaki Pastor Pons
Researcher at PhD School
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Orosia Lucha
Role: STUDY_DIRECTOR
Universidad de Zaragoza
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto deTerapias Integrativas
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Ditthakasem K, Kolar JC. Deformational Plagiocephaly: A Review. Pediatr Nurs. 2017 Mar-Apr;43(2):59-64.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PMT1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.