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临床试验/NCT04408417
NCT04408417已完成不适用

Automated Harness Tightener for Child Safety Seat

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Change in harness tension

研究概览

简要总结

The overall objective of this study is to evaluate the efficacy of a tensioning progress indicator light to achieve proper harness tensioning in child safety seats.

详细描述

The primary objective of the study is to determine whether a prototype convertible child safety seat with visual indication of successful tensioning technology reduces the amount of harness slack compared with a standard safety seat. The secondary objective of the study is to assess caregivers' perceptions of the quality, design, and ease of use of the prototype child safety seat tensioning progress indicator lights. Participants will be parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age. Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to harness their child into two versions of a convertible child safety seat, twice in each car seat. The intervention seat will be equipped with the technology that gives visual indication of successful harness tensioning. Participants will be observed, assessed, and asked a series of survey questions after each harnessing period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants. Participants will be aware that the order of the harnessing periods is randomly assigned. Assignment status will not be concealed from the research assistants enrolling the dyads or the participants, or the rest of the study team.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-75 years who are the parent/legal guardian of a child aged 6 months-24 months
  • Parent/legal guardian has harnessed a child into a safety seat in the last 30 days

排除标准

  • Non-fluency in written and/or spoken English
  • Parent/legal guardian cannot install, and/or child cannot be harnessed into, a safety seat due to a physical or health limitation

结局指标

主要结局

Change in harness tension

时间窗: Up to 5 minutes

After each of the four harnessing periods, the tension force on the safety seat harness will be measured with a load cell in Newtons and/or a qualitative "pinch" test which provides a binary value of tight vs not-tight. Within-participant harness tension is compared.

次要结局

  • Participant perceptions of usability of the tension progress indicator light technology: survey(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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