Safety and efficacy of cranial remolding helmet with ventilation mechanism for treatment of deformational plagiocephaly

Phase 2

Recruiting

• Conditions: deformational plagiocephaly; deformational plagiocephaly, positional plagiocephaly, nonsynostotic plagiocephaly; D049068

• Registration Number: JPRN-jRCTs032220285
• Lead Sponsor: Hikosaka Makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety outcome: adverse events during helmet therapy

Secondary Outcome Measures

Name	Time	Method
efficacy outcome: improvement in cranial asymmetry<br>other outcomes: Argenta classification, cephalic index, head circumference, number of unexpected extra visit for helmet adjustment.