## Protocol Section
### Identification Module
**NCT ID:** NCT06425172

**Brief Title:** Monitoring System for Cranial Orthoses

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

#### Organization Study ID Info
**ID:** STU-2022-0556
#### Organization
**Class:** OTHER
**Full Name:** University of Texas Southwestern Medical Center
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** National Institute on Disability, Independent Living, and Rehabilitation Research

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Texas Southwestern Medical Center

#### Responsible Party

**Investigator Affiliation:** University of Texas Southwestern Medical Center

**Investigator Full Name:** Tiffany Graham

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day, 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.

### Conditions Module

**Conditions:**

- Plagiocephaly

- Brachycephaly

- Deformational Plagiocephaly

- Deformational Posterior Plagiocephaly

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 12

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.

**Intervention Names:**

- Device: Cranial Remolding Orthosis

**Label:** Infants with with deformational head shapes

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Infants with with deformational head shapes

**Description:** A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

**Name:** Cranial Remolding Orthosis

**Other Names:**

- Custom Helmet

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Wear time monitoring and validation

**Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

**Description:** We will examine pressure in the void space of the helmet throughout the 8 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).

**Measure:** Fit monitoring

**Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

#### Secondary Outcomes

**Description:** Parents will take a survey regarding their experience with the research helmet

**Measure:** Survey Participation

**Time Frame:** Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year.

**Description:** The wear time based on iButton and custom temperature readings will be compared to the caregiver-reported wear time log and any differences in log times reviewed.

**Measure:** Wear time comparison between objective and subjective reporting

**Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 18 Months

**Minimum Age:** 3 Months

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Infants who are clinically indicated for cranial remolding orthoses.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Tiffany.Graham@utsouthwestern.edu

**Name:** Tiffany Graham, MS

**Phone:** 2146458250

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** University of Texas Southwestern Medical Center

**Name:** Tiffany Graham, MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Individual participant data will be protected and only shared within the research team and treating practitioners.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019465

- Term: Craniofacial Abnormalities

- ID: D000009139

- Term: Musculoskeletal Abnormalities

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000000013

- Term: Congenital Abnormalities

- ID: D000013580

- Term: Synostosis

- ID: D000004413

- Term: Dysostoses

- ID: D000001848

- Term: Bone Diseases, Developmental

- ID: D000001847

- Term: Bone Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29382

- Name: Plagiocephaly

- Relevance: HIGH

- As Found: Plagiocephaly

- ID: M26018

- Name: Plagiocephaly, Nonsynostotic

- Relevance: HIGH

- As Found: Deformational Plagiocephaly

- ID: M6613

- Name: Craniosynostoses

- Relevance: HIGH

- As Found: Brachycephaly

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M21420

- Name: Craniofacial Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M12096

- Name: Musculoskeletal Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16357

- Name: Synostosis

- Relevance: LOW

- As Found: Unknown

- ID: M7587

- Name: Dysostoses

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5127

- Name: Bone Diseases, Developmental

- Relevance: LOW

- As Found: Unknown

- ID: T4584

- Name: Plagiocephaly

- Relevance: HIGH

- As Found: Plagiocephaly

- ID: T1638

- Name: Craniosynostosis

- Relevance: LOW

- As Found: Unknown

- ID: T5091

- Name: Saethre-Chotzen Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059041

- Term: Plagiocephaly

- ID: D000049068

- Term: Plagiocephaly, Nonsynostotic

- ID: D000003398

- Term: Craniosynostoses

### Misc Info Module

- Version Holder: 2024-05-31
