Usability Evaluation of the Safer Seat

NCT07011446 | Completed FDA Device

• 1 other identifier: STUDY24090134
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is an initial usability assessment of a vehicle Seat Transfer device, the Safer Seat. The study will involve target end users (individuals with mobility impairments) trialing the Safer Seat and providing feedback via the Technology Acceptance Model Survey's Modified from Davis (1985) and brief qualitative interview.

Conditions

Impaired Mobility; Impaired Balance

Keywords

Transfers; Mobility Aid; Mobility Support

Outcome Measures

Primary Outcomes (1)

• Physical Mobility Scale

  Used to rate ability level in sit to stand and stand to sit transfers from 0 if not able to bear weight, to 5 if independent and not needing to use upper extremities for assistance.

  Day 1

Secondary Outcomes (3)

• Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use questionnaires

  Day 1

• Semi structured interview

  Day 1

• Demographic Data

  Day 1

Study Arms (1)

Safer Seat Trial

EXPERIMENTAL

This study utilizes a single arm design per the goals of the usability trial. The intervention centers on trialing vehicle seat transfers with and without the Safer Seat.

Device: Safer Seat Usability Trial

Interventions

Safer Seat Usability Trial DEVICE

Participants will be asked to transfer onto/off of the vehicle seat using their normal method of transfer and then to trial transferring onto/off of a vehicle seat with the Safer Seat 1 one or more times with study personnel. Demographic data will be recorded for all participants to include age, sex, and type of mobility disability. Transfers will be observed by the research personnel and success in transfers will be recorded according to the Physical Mobility Scale. Usefulness and usability of the Safer Seat transfer experience will be reported by participants via Technology Acceptance Model Surveys; and participants will engage in a brief semi structured interview that will be audio recorded and transcribed via Microsoft Teams.

Safer Seat Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Currently living with impaired mobility, strength, or balance
• Self-reported ability to complete transfers at modified independent (independent with the use of an assistive device) or minimal assist (a small amount of assistance from another person) level

Sponsors & Collaborators

• Julie Faieta: lead

Study Sites (1)

Univeristy of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

Location

Study Officials

• Julie Faieta, PhD, MOT

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 8, 2025
• Study Start: April 9, 2025
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)