The Effect of a Bioactive Fabric Sleeve

NCT ID: NCT06234202

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bioactive Sleeve then Control Sleeve

Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches

Group Type EXPERIMENTAL

Bioactive Sleeve

Intervention Type DEVICE

Pitchers will wear a bioactive sleeve immediately post-game through overnight.

Control Sleeve

Intervention Type DEVICE

Pitchers will wear a non-bioactive sleeve immediately post-game through overnight.

Control Sleeve then Bioactive Sleeve

Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches

Group Type EXPERIMENTAL

Bioactive Sleeve

Intervention Type DEVICE

Pitchers will wear a bioactive sleeve immediately post-game through overnight.

Control Sleeve

Intervention Type DEVICE

Pitchers will wear a non-bioactive sleeve immediately post-game through overnight.

Interventions

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Bioactive Sleeve

Pitchers will wear a bioactive sleeve immediately post-game through overnight.

Intervention Type DEVICE

Control Sleeve

Pitchers will wear a non-bioactive sleeve immediately post-game through overnight.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stanford Baseball Player

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Challenger Health, LLC

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Michael T. Freehill

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Freehill, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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72979

Identifier Type: -

Identifier Source: org_study_id

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