Impaired MobilityNCT07011446
Usability Evaluation of the Safer Seat
A study testing Safer Seat Usability Trial in people with Impaired Mobility and Impaired Balance, run by Julie Faieta at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Mobility, Impaired Balance
- What is being tested?
- Safer Seat Usability Trial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Pittsburgh
Pittsburgh, Pennsylvania, 15203
About this study
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.
Read the detailed description
This study investigates the initial usability of the Safer Seat vehicle transfer aid. Participants with impaired mobility, strength, or balance are being asked to transfer onto and off of a vehicle seat with and without the device to trial its usability. In addition, transfers are doing rated by a licensed occupational therapist according to the Physical Mobility Scale to determine if independence level is affected. Usability evaluation is being done both qualitatively and quantitatively using Technology Assessment Surveys and a semi-structured interview. Insight gained through this initial trial will be used to refine the design of the Safer Seat.
- Conditions
- Impaired Mobility, Impaired Balance
- Being tested
- Safer Seat Usability Trial
- Keywords
- Transfers, Mobility Aid, Mobility Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safer Seat Usability TrialDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Safer Seat Usability Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (4)
Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use Questionnaires
Modified 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).
Measured: Day 1
Semi-Structured Interview: Usability Themes
Participants 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.
Measured: Day 1
Demographic Data: Diagnosis
Diagnoses 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.
Measured: Day 1
Demographic Data: Time Since Injury
Time since injury was not collected, it was not applicable to all participants.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start9 Apr 2025
- Primary completion1 Jun 2025
- Study completion1 Aug 2025
Why it stopped: Study spanned intended time period but fell short of targeted recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impaired MobilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Faieta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Faieta, University of Pittsburgh
- Investigators
- Julie Faieta, PhD, MOT, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011446
- Sponsor's protocol ID
- STUDY24090134
- Status last verified
- Jul 2026
- First submitted
- 20 May 2025
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Evaluation of the Safer Seat
- ClinicalTrials.gov ID
- NCT07011446
- Acronym / sponsor ID
- STUDY24090134
- Conditions
- Impaired Mobility, Impaired Balance
- Keywords
- Transfers, Mobility Aid, Mobility Support
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study spanned intended time period but fell short of targeted recruitment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Julie FaietaUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study investigates the initial usability of the Safer Seat vehicle transfer aid. Participants with impaired mobility, strength, or balance are being asked to transfer onto and off of a vehicle seat with and without the device to trial its usability. In addition, transfers are doing rated by a licensed occupational therapist according to the Physical Mobility Scale to determine if independence level is affected. Usability evaluation is being done both qualitatively and quantitatively using Technology Assessment Surveys and a semi-structured interview. Insight gained through this initial trial will be used to refine the design of the Safer Seat.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safer Seat Trial | Experimental | Device: Safer Seat Usability TrialThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safer Seat Usability TrialParticipants 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. | Device | Safer Seat Trial |
Primary outcome
Physical Mobility Scale
Time frame: Day 1
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.
4 secondary outcomes
Technology Acceptance Model Perceived Ease of Use, Usefulness, and Attitudes Toward Use Questionnaires
Time frame: Day 1
Semi-Structured Interview: Usability Themes
Time frame: Day 1
Demographic Data: Diagnosis
Time frame: Day 1
Demographic Data: Time Since Injury
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Faieta, PhD, MOT principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safer Seat Usability Trial in people with Impaired Mobility and Impaired Balance, run by Julie Faieta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Mobility Scale (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.