A Monitoring System for Cranial Remolding Orthoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fit monitoring
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)
排除标准
- •non-English speaking caregivers
- •infants with craniosynostosis or those not indicated for cranial remolding
- •infants with developmental comorbidities which affect cranial growth
研究组 & 干预措施
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.
干预措施: Cranial Remolding Orthosis (Device)
结局指标
主要结局
Fit monitoring
时间窗: 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).
Wear time monitoring and validation
时间窗: 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.
次要结局
- Survey Participation(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(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.)
研究者
Tiffany Graham
Associate Professor
University of Texas Southwestern Medical Center