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临床试验/NCT06384989
NCT06384989已完成不适用

Phase II - Safety-Enhancing Motor Vehicle Child Safety Seat

Minnesota HealthSolutions1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Overall Correct Use of Load Leg

研究概览

简要总结

This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design.

详细描述

A descriptive study will be conducted to determine whether human subjects are able to install the new feature of the prototype car seat correctly. Participants will be presented with the prototype car seat and a set of basic written instructions and labels to guide their installations. The percentage of participants who use the new feature and use it correctly will be reported. Any installation errors on other parts of the child seat (seat belt, lower anchors, top tether) will also be reported.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 or older
  • •Be a care provider to a child who is up to 4 years of age
  • •Have installed a child safety seat in the last 2 years
  • •Able to lift and install a child safety seat into a vehicle
  • •English-speaking (because consent forms and explanation will be given in English)

排除标准

  • •Not meeting any of the above

结局指标

主要结局

Overall Correct Use of Load Leg

时间窗: 1 study visit, an average of 30 minutes

Number of participants who correctly install the load leg independently, without needing any prompt to use it.

Attempt to Use Load Leg Without Prompting

时间窗: 1 study visit, an average of 30 minutes

Number of participants who noticed the load leg on their own, unfolded it from storage, and attempted to use it without being prompted by the researcher.

Correct Load Leg Length

时间窗: 1 study visit, an average of 30 minutes

Number of participants who set the load leg to the correct length, including those who needed prompted to use it

Correct Load Leg Angle

时间窗: 1 study visit, an average of 30 minutes

Number of participants who set the load leg to the correct angle, including those who needed prompted to use it.

次要结局

  • Correct Understanding of Load Leg's Purpose(1 study visit, an average of 30 minutes)
  • Participants Who Like Having the Load Leg(1 study visit, an average of 30 minutes)

研究者

发起方
Minnesota HealthSolutions
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Julie Mansfield

Research Assistant Professor

Minnesota HealthSolutions

研究点 (1)

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