Reliability and Validity of the PReFS | NCT07280923

Studies
Reliability and Validity of the PReFS

NCT07280923

Sponsor

Baylor University

Status

Recruiting

Last Update Posted

Dec 23, 2025Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Neurologic Disorders
Spinal Cord Injury
Stroke
Traumatic Brain Injury

Interventions

Interview

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2025Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Dec 1, 2025

First Submission Date that Met QC Criteria

Dec 1, 2025

First Posted Date

Dec 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Wheelchair Users		Individuals with a neurologic disorder who are primary wheelchair users	Other: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Participants will be interviewed for this study. No intervention will occur.	Wheelchair Users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interview	Each participant will take part in a 10-minute interview to answer questions on the PReFS	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary wheelchair user
diagnosed with a neurologic disorder

Exclusion Criteria:

does not use a wheelchair for more than 50% of waking hours

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals with a diagnosed neurologic disorder who are primary wheelchair users.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonia Silva, DPT	Contact	757-831-4354		antonia_silva@baylor.edu
Elizabeth Ardolino, PT, PhD	Contact	215-605-9319		liz_ardolino@baylor.edu

Overall Officials

Name	Affiliation	Role
Elizabeth Ardolino, PT, PhD	Baylor University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University	Recruiting	Waco	Texas	76798	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009422	Nervous System Diseases
D013119	Spinal Cord Injuries
D020521	Stroke
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided