RecoveryNCT06234202
The Effect of a Bioactive Fabric Sleeve
A study testing Bioactive Sleeve in people with Recovery, run by Stanford University at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recovery
- What is being tested?
- Bioactive Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Feb 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stanford Baseball Player
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Virginia
Charlottesville, Virginia, 22903
University of California, Davis
Davis, California, 95616
University of Florida
Gainesville, Florida, 32611
University of San Diego
San Diego, California, 92110
University of Washington
Seattle, Washington, 98195
Stanford University
Stanford, California, 94305
About this study
Official title: The Effect of a Bioactive Fabric Sleeve on Recovery in Division I Collegiate Baseball Players
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.
- Conditions
- Recovery
- Being tested
- Bioactive Sleeve, Control Sleeve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive SleeveDevice
Pitchers will wear a bioactive sleeve immediately post-game through overnight.
Control SleeveDevice
Pitchers will wear a non-bioactive sleeve immediately post-game through overnight.
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Sleeve then Control Sleeve | Experimental | Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches Receives: Device: Bioactive Sleeve; Device: Control Sleeve |
| Control Sleeve then Bioactive Sleeve | Experimental | Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches Receives: Device: Bioactive Sleeve; Device: Control Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start16 Feb 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecoveryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Challenger Health, LLC
- Responsible party
- Principal investigator, Michael T. Freehill, Stanford University
- Investigators
- Michael Freehill, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234202
- Sponsor's protocol ID
- 72979
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Bioactive Fabric Sleeve on Recovery in Division I Collegiate Baseball Players
- ClinicalTrials.gov ID
- NCT06234202
- Acronym / sponsor ID
- 72979
- Conditions
- Recovery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Challenger Health, LLC
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jan 2024 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Sleeve then Control Sleeve | Experimental | Device: Bioactive Sleeve, Device: Control SleeveEach 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 | Experimental | Device: Bioactive Sleeve, Device: Control SleeveEach pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stanford Baseball Player
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Bioactive SleevePitchers will wear a bioactive sleeve immediately post-game through overnight. | Device | Bioactive Sleeve then Control Sleeve, Control Sleeve then Bioactive Sleeve |
| Control SleevePitchers will wear a non-bioactive sleeve immediately post-game through overnight. | Device | Bioactive Sleeve then Control Sleeve, Control Sleeve then Bioactive Sleeve |
Primary outcome
Subjective Soreness Score
Time frame: Baseline through 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- 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.
Michael Freehill, MD principal investigator
Stanford University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Sleeve in people with Recovery, run by Stanford University at 6 sites 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 1 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Subjective Soreness Score (time frame: Baseline through 6 months). 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 7 Jul 2026.