- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280923
Reliability and Validity of the PReFS (PReFS)
December 17, 2025 updated by: Baylor University
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antonia Silva, DPT
- Phone Number: 757-831-4354
- Email: antonia_silva@baylor.edu
Study Contact Backup
- Name: Elizabeth Ardolino, PT, PhD
- Phone Number: 215-605-9319
- Email: liz_ardolino@baylor.edu
Study Locations
-
-
Texas
-
Waco, Texas, United States, 76798
- Recruiting
- Baylor University
-
Contact:
- Antonia Silva, DPT
- Phone Number: 757-831-4354
- Email: antonia_silva@baylor.edu
-
Contact:
- Elizabeth Ardolino, PT, PhD
- Phone Number: 215-605-9319
- Email: liz_ardolino@baylor.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Individuals with a diagnosed neurologic disorder who are primary wheelchair users.
Description
Inclusion Criteria:
- primary wheelchair user
- diagnosed with a neurologic disorder
Exclusion Criteria:
- does not use a wheelchair for more than 50% of waking hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Wheelchair Users
Individuals with a neurologic disorder who are primary wheelchair users
|
Participants will be interviewed for this study.
No intervention will occur.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interview
Time Frame: Baseline
|
Each participant will take part in a 10-minute interview to answer questions on the PReFS
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elizabeth Ardolino, PT, PhD, Baylor University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
December 1, 2025
First Submitted That Met QC Criteria
December 1, 2025
First Posted (Estimated)
December 12, 2025
Study Record Updates
Last Update Posted (Actual)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 17, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Spinal Cord Diseases
- Brain Injuries
- Brain Injuries, Traumatic
- Stroke
- Spinal Cord Injuries
- Nervous System Diseases
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
Other Study ID Numbers
- 2339946
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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