An interventional study of Pediatric Manual Therapy and Educational Physical Therapy in Plagiocephaly, Plagiocephaly, Nonsynostotic and Plagiocephaly, Positional, sponsored by Universidad de Zaragoza. Completed at 1 site in Spain. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
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
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.
16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.
Browse Plagiocephaly studies →Universidad de Zaragoza is the lead sponsor of 111 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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
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
Also known as: Manual Therapy, Manual Physical Therapy
Also known as: Pediatric Physical Therapy
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
Time frame: 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
Time frame: 10 weeks
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
Time frame: 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.
Time frame: 10 weeks
Cranial circumference
Measured in cm with a measuring tape.
Time frame: 10 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2017 to primary completion in Jul 2019, 30 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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