---
title: Monitoring System for Cranial Orthoses
nct_id: NCT06425172
overall_status: RECRUITING
sponsor: University of Texas Southwestern Medical Center
study_type: OBSERVATIONAL
primary_condition: Plagiocephaly
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06425172.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06425172"
ct_last_update_post_date: 2025-07-03
last_seen_at: "2026-05-12T07:13:02.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Monitoring System for Cranial Orthoses

**Official Title:** A Monitoring System for Cranial Remolding Orthoses

**NCT ID:** [NCT06425172](https://clinicaltrials.gov/study/NCT06425172)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** University of Texas Southwestern Medical Center
- **Collaborators:** National Institute on Disability, Independent Living, and Rehabilitation Research
- **Conditions:** Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
- **Start Date:** 2024-08-19
- **Completion Date:** 2026-06-01
- **CT.gov Last Update:** 2025-07-03

## Brief Summary

This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).

## Detailed Description

This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow). Although cranial remolding treatment has been used successfully for over 20 years, there is no clinical standard for objective monitoring of the fit and wear time.

In total, participation will consist of 7 visits over 11 weeks: (1) measurements and clinical evaluation \[approximately 60 minutes\], (2) fitting of standard helmet and pre-fitting and/or fitting of the research helmet \[approximately 60 minutes\], (3) fitting of research helmet (if not done at Visit #2) and in-office testing \[approximately 2 hours\], (4)/(5)/(6) follow up visits for research helmet \[approximately 30-60 minutes each\], and (7) final follow up visit and in-office testing for the research helmet \[approximately 2 hours\].

During the 8-9 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day (after a break-in schedule), and caregivers will keep a log of helmet wear time and any side effects (such as skin irritations), if they occur. The child will be seen clinically every 2 weeks (or more often, if caregivers request additional checkups).

At the end of the trial, participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet.

## Eligibility

- **Minimum age:** 3 Months
- **Maximum age:** 18 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)

Exclusion Criteria:

* non-English speaking caregivers
* infants with craniosynostosis or those not indicated for cranial remolding
* infants with developmental comorbidities which affect cranial growth
```

## Arms

- **Infants with with deformational head shapes** — Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.

## Interventions

- **Cranial Remolding Orthosis** (DEVICE) — A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

## Primary Outcomes

- **Wear time monitoring and validation** _(time frame: Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.)_ — The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software.
- **Fit monitoring** _(time frame: Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.)_ — The investigators will examine pressure in the void space of the helmet throughout the 8-9 weeks of wear time. In theory, the pressure in this area should never increase as the cranium should not come in contact with this sensor no matter what position the infant is in (i.e. laying down, sitting, etc).

## Secondary Outcomes

- **Survey Participation** _(time frame: Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year.)_
- **Wear time comparison between objective and subjective reporting** _(time frame: Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.)_

## Locations (1)

- UT Southwestern Medical Center, Dallas, Texas, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ut southwestern medical center|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06425172.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06425172*  
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