The Effect of a Bioactive Fabric Sleeve
1 other identifier
interventional
13
1 country
6
Brief Summary
In-season pitch volume have been shown to relate to arm soreness in collegiate baseball players. Arm soreness is a common ailment following a pitching appearance due to the adaptation to soft tissue in response to a repetitive load to the throwing arm. Specifically, ongoing and accumulated fatigue and soreness to the flexor pronator mass region of the arm may be a predecessor for UCL injury. Different recovery modalities such as a bioactive fabric sleeve may give pitchers a recovery advantage throughout a baseball season. The primary purpose of this study is to determine if there is a difference in subjective soreness of the flexor pronator mass the day following a game pitching appearance using a sleeve with bioactive fabric which potentially improves cellular function versus a control sleeve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
February 27, 2026
May 1, 2025
3.3 years
January 22, 2024
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Soreness Score
Subjective soreness questionnaires to rank soreness, tightness, and discomfort of the medial forearm on a 1 to 10 scale will be collected throughout the baseball seasons.
Baseline through 6 months
Study Arms (2)
Bioactive Sleeve then Control Sleeve
EXPERIMENTALEach pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches
Control Sleeve then Bioactive Sleeve
EXPERIMENTALEach pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches
Interventions
Pitchers will wear a bioactive sleeve immediately post-game through overnight.
Pitchers will wear a non-bioactive sleeve immediately post-game through overnight.
Eligibility Criteria
You may qualify if:
- Stanford Baseball Player
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Challenger Health, LLCcollaborator
- Stanford Universitylead
Study Sites (6)
University of California, Davis
Davis, California, 95616, United States
University of San Diego
San Diego, California, 92110, United States
Stanford University
Stanford, California, 94305, United States
University of Florida
Gainesville, Florida, 32611, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
University of Washington
Seattle, Washington, 98195, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Freehill, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 22, 2024
First Posted
January 31, 2024
Study Start
February 16, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
February 27, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share