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Clinical Trials/NCT06384989
NCT06384989CompletedNot Applicable

Phase II - Safety-Enhancing Motor Vehicle Child Safety Seat

Minnesota HealthSolutions1 site in 1 country50 target enrollmentStarted: May 22, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Overall Correct Use of Load Leg

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •Not meeting any of the above

Outcomes

Primary Outcomes

Overall Correct Use of Load Leg

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Minnesota HealthSolutions
Sponsor Class
Industry
Responsible Party
Principal Investigator
Principal Investigator

Julie Mansfield

Research Assistant Professor

Minnesota HealthSolutions

Study Sites (1)

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