Trial Outcomes & Findings for Usability Evaluation of the Safer Seat (NCT NCT07011446)
NCT ID: NCT07011446
Last Updated: 2026-08-04
Results Overview
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.
TERMINATED
NA
8 participants
Day 1
2026-08-04
Participant Flow
All 8 participants were recruited through Pitt+Me, the University of Pittsburgh's research participant registry. Individuals who met eligibility criteria were contacted directly by the study team and scheduled for informed consent and data collection.
Participant milestones
| Measure |
Safer Seat Trial
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.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Safer Seat Trial
n=8 Participants
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. Therefore, participants included adutls with decreased mobility, strength, and/or balance.
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
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4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1Used 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.
Outcome measures
| Measure |
Safer Seat Trial
n=8 Participants
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. Therefore, participants included adutls with decreased mobility, strength, and/or balance.
|
|---|---|
|
Physical Mobility Scale
Sitting to Standing Safer Seat
|
3.50 Score on a scale
Standard Deviation 1.31
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Physical Mobility Scale
Standing to Sitting Control
|
3.75 Score on a scale
Standard Deviation 1.04
|
|
Physical Mobility Scale
Standing to Sitting Safer Seat
|
3.88 Score on a scale
Standard Deviation 0.64
|
|
Physical Mobility Scale
Sitting to Standing Control
|
3.25 Score on a scale
Standard Deviation 1.39
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SECONDARY outcome
Timeframe: Day 1Modified from Davis (1985) surveys to assess Perceived Usefulness, Perceived Ease of Use, and Attitudes Toward Use. Each subscale score reflects the mean of its items; subscales are not combined into a total score. Perceived Usefulness (7 items): subscale range 1 to 5; higher scores indicate greater perceived usefulness (better outcome). Perceived Ease of Use (10 items): subscale range 1 to 5; higher scores indicate greater perceived ease of use (better outcome). For both subscales, items are rated on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). Four items are phrased negatively and are reverse coded prior to scoring, such that higher scores consistently reflect a more favorable response. Attitudes Toward Use (5 items): subscale range 0 to 100; items rated on a visual analog scale from 0 (favorable pole) to 100 (unfavorable pole), reversed for scoring so that higher scores indicate more favorable attitudes toward use (better outcome).
Outcome measures
| Measure |
Safer Seat Trial
n=8 Participants
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. Therefore, participants included adutls with decreased mobility, strength, and/or balance.
|
|---|---|
|
Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use Questionnaires
Perceived Usefulness
|
3.98 Scores on a scale
Standard Deviation 0.72
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Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use Questionnaires
Perceived Ease of Use
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4.08 Scores on a scale
Standard Deviation 0.47
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Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use Questionnaires
Attitudes Toward Use
|
82.20 Scores on a scale
Standard Deviation 14.32
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SECONDARY outcome
Timeframe: Day 1Participants completed a six-question semi-structured interview focused on usability and usefulness of the Safer Seat. Questions served as qualitative prompts; responses were analyzed thematically. The number of participants whose responses reflected each identified theme is reported. Where responses were conditional or context-dependent, participants are counted only if their response reflected the theme without qualification.
Outcome measures
| Measure |
Safer Seat Trial
n=8 Participants
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. Therefore, participants included adutls with decreased mobility, strength, and/or balance.
|
|---|---|
|
Semi-Structured Interview: Usability Themes
Affirmed Safer Seat addresses a real problem
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7 Participants
|
|
Semi-Structured Interview: Usability Themes
Expressed unconditional intent to use Safer Seat routinely
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2 Participants
|
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Semi-Structured Interview: Usability Themes
Expressed conditional intent to use (vehicle type, portability, or fit dependent)
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5 Participants
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Semi-Structured Interview: Usability Themes
Expressed no intent to use Safer Seat routinely
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1 Participants
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Semi-Structured Interview: Usability Themes
Indicated willingness to recommend to others
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8 Participants
|
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Semi-Structured Interview: Usability Themes
Identified portability as a design refinement area
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3 Participants
|
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Semi-Structured Interview: Usability Themes
Identified vehicle compatibility as a design refinement area
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3 Participants
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SECONDARY outcome
Timeframe: Day 1Diagnoses were categorized by condition type. Individual diagnoses included fibromyalgia and functional seizure disorder, hip replacement, paraplegia, myasthenia gravis, peripheral neuropathy, bilateral club feet with hip dysplasia, chronic pain with lumbar degenerative disc disease, and sciatica with degenerative disc disease.
Outcome measures
| Measure |
Safer Seat Trial
n=8 Participants
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. Therefore, participants included adutls with decreased mobility, strength, and/or balance.
|
|---|---|
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Demographic Data: Diagnosis
Paraplegia
|
1 Participants
|
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Demographic Data: Diagnosis
Musculoskeletal Condition
|
4 Participants
|
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Demographic Data: Diagnosis
Neurological Condition
|
3 Participants
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SECONDARY outcome
Timeframe: Day 1Population: Time since injury was not collected during this study. The outcome was pre-specified in the protocol with the qualifier "if appropriate," as time since injury is not applicable to all diagnoses represented in this sample (e.g., fibromyalgia, hip replacement, degenerative disc disease). No participants had time since injury data recorded.
Time since injury was not collected, it was not applicable to all participants.
Outcome measures
Outcome data not reported
Adverse Events
Safer Seat Trial
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place