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Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

NCT03970395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-02-12

Study results available
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Summary

The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.

Conditions

  • Nonsynostotic Plagiocephaly

Interventions

OTHER

Osteopathic manipulative therapy (OMTh)

The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.

OTHER

Light Touch Therapy (LTT)

The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.

OTHER

Repositioning therapy

It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.

Sponsors & Collaborators

  • Scuola Superiore di Osteopatia Italiana

    collaborator OTHER

  • PRIOLO CLAUDIO

    lead OTHER

Principal Investigators

  • Claudio G Priolo, Medical · Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy

  • Daniele Farina, Medical · Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2020-02-26
Completion
2020-02-26

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970395 on ClinicalTrials.gov