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

JRCT ID: jRCTs032220285

Registered date:22/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: deformational plagiocephaly
• Date of first enrollment: 22/08/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): cranial remolding helmet with ventilation mechanism

Outcome(s)

• Primary Outcome: safety outcome: adverse events during helmet therapy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 6month old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hikosaka Makoto
• Source(s) of Monetary Support: Marubeni Information Systems Co., Ltd.