Hanger Helmet Study

Prospective Study to Evaluate Effectiveness of the Hanger Helmet vs the P Pod Helmet in Improving the Head and Face Symmetry

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02561728

Enrollment

Registered

2015-09-28

Start date

2016-07-31

Completion date

2023-10-31

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniosynostosis, Plagiocephaly

Keywords

Helmet, Hangar, P-Pod, Plagiocephaly, Surgery

Brief summary

The purpose of this study is to examine a group of patients requiring helmet therapy (either patients with plagiocephaly or post-surgical patients) to compare outcomes of infants treated with the Hanger helmet (Hanger, Inc.) to outcomes of infants treated with the P Pod Helmet (Lorica Scientific, LLC). Currently both helmets are prescribed at CCHMC. The investigators' goal is to determine which helmet is more effective in skull remodeling and to standardize the investigators' care for these patient types.

Detailed description

The use of helmet therapy to correct abnormal head shape due to either positional plagiocephaly secondary to pressure on the posterior skull with infant position and furniture use or after minimally invasive surgery for craniosynostosis is currently the treatment of choice at Cincinnati Children's Hospital (CCHMC). Helmet treatment in children with positional plagiocephaly is initiated for infants between 4 and 9 months of age (at CCHMC). Helmet treatment for children undergoing surgery for craniosynostosis is initiated following endoscopic cranial vault and stip craniectomy surgery after swelling from the surgery has subsided (generally within two weeks of surgery). Treatment with helmet therapy has been shown to improve head shape in both patient diagnoses. There are two types of helmets available to the investigators' patients (Hanger Helmet and P Pod Helmet) and to date, no research has evaluated whether one helmet type is more efficient in reshaping the skull than the other type. The current study seeks to fill this gap in the literature by comparing the outcomes for infants treated with a Hanger Helmet to the outcomes for infants treated with a P Pod Helmet. The investigators will measure skull symmetry with a 3dMD camera and take routine cross lateral measurements with a caliper designed for this use. Infants participating in the study will be randomized using a computerized program, Minim.

Interventions

DEVICEHangar Helmet

Child will be fitted with the Hangar Helmet

DEVICEP-Pod Helmet

Child will be fitted with the P-Pod Helmet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 10 Months

Healthy volunteers

Inclusion criteria

* Diagnosis which requires helmet therapy treatment * Under 10 months of age

Exclusion criteria

* Children who do not need helmet therapy

Design outcomes

Primary

Measure	Time frame	Description
Root Mean Square (RMS)	5 years	RMA is measured by first taking a picture of the child's head with the helmet on with a 3dMD camera. RMS is a measurement unique to the 3dMD camera. RMS will be used to quantify symmetry by superimposing left and right quadrants and calculating the mean value of aggregate distances between surfaces.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026