Neurologic DisordersPReFSNCT07280923
Reliability and Validity of the PReFS
An observational study of Neurologic Disorders and Spinal Cord Injury, run by Baylor University at 1 site in United States.
Trial summary
This study is testing the psychometric properties of a new tool to determine recommendations for pressure relief frequency in wheelchair users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorders, Spinal Cord Injury, Stroke
- What is being tested?
- Interview
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Individuals with a diagnosed neurologic disorder who are primary wheelchair users.
Who may be able to join
- primary wheelchair user
- diagnosed with a neurologic disorder
Who cannot join
- does not use a wheelchair for more than 50% of waking hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Pressure Relief Frequency Scale
This study is testing the psychometric properties of a new tool to determine recommendations for pressure relief frequency in wheelchair users.
Read the detailed description
The goal of the proposed study is to establish the content validity and inter-rater reliability of a new tool, the Pressure Relief Frequency Scale (PReFS). Findings from this study will provide clinicians with a tool that can be used to develop an individualized approach to teaching patients how frequently to perform weight shifts. The part of the study will establish the inter-rater reliability of the PReFs through video recordings of individuals who are wheelchair users.
- Being tested
- Interview
- Keywords
- wheelchair user, pressure relief, skin integrity
- Medical subject headings
- Nervous System Diseases, Spinal Cord Injuries, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participants will be interviewed for this study. No intervention will occur.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Users | Individuals with a neurologic disorder who are primary wheelchair users Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview
Each participant will take part in a 10-minute interview to answer questions on the PReFS
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Dec 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ardolino, PT, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280923
- Sponsor's protocol ID
- 2339946
- Acronym
- PReFS
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Pressure Relief Frequency Scale
- ClinicalTrials.gov ID
- NCT07280923
- Acronym / sponsor ID
- PReFS / 2339946
- Keywords
- wheelchair user, pressure relief, skin integrity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing the psychometric properties of a new tool to determine recommendations for pressure relief frequency in wheelchair users.
Detailed description
The goal of the proposed study is to establish the content validity and inter-rater reliability of a new tool, the Pressure Relief Frequency Scale (PReFS). Findings from this study will provide clinicians with a tool that can be used to develop an individualized approach to teaching patients how frequently to perform weight shifts. The part of the study will establish the inter-rater reliability of the PReFs through video recordings of individuals who are wheelchair users.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Users | – | Other: InterviewIndividuals with a neurologic disorder who are primary wheelchair users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with a diagnosed neurologic disorder who are primary wheelchair users.
Key inclusion criteria (2 listed)
- primary wheelchair user
- diagnosed with a neurologic disorder
Key exclusion criteria (1 listed)
- does not use a wheelchair for more than 50% of waking hours
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 |
|---|---|---|
| InterviewParticipants will be interviewed for this study. No intervention will occur. | Other | Wheelchair Users |
Primary outcome
Interview
Time frame: Baseline
Each participant will take part in a 10-minute interview to answer questions on the PReFS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth Ardolino, PT, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorders and Spinal Cord Injury, run by Baylor University 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 2 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interview (time frame: Baseline). 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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.