deformational plagiocephaly deformational plagiocephaly, positional plagiocephaly, nonsynostotic plagiocephaly
Conditions
Interventions
cranial remolding helmet with ventilation mechanism
helmet, cranial remolding
Sponsors
Hikosaka Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with deformational plagiocephaly 2. Patients who are younger than 6 months old at the start of helmet therapy 3. Patients with cranial asymmetry =>15 4. Patients who gained head and neck control 5. Patients whose guardians showed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with conditions which affect cranial shape (ie: hydrocephalus, craniosynostosis). 2. Patients with syndrome and other systemic comorbidity. 3. Patients with comorbidity of other organs (ie: metabolic disorders, heart defects). 4. Patients with disorders of head skin which makes helmet therapy difficult. 5. Patients who are expected to be lost to follow up during the study period. 6. Patients who are judged to be inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety outcome: adverse events during helmet therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy outcome: improvement in cranial asymmetry other outcomes: Argenta classification, cephalic index, head circumference, number of unexpected extra visit for helmet adjustment. | — |
Contacts
Public ContactMakoto Hikosama
National Center for Child Health and Development
Outcome results
None listed