Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06234202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Bioactive Fabric Sleeve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Soreness Score', 'timeFrame': 'Baseline through 6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Recovery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stanford Baseball Player\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06234202', 'briefTitle': 'The Effect of a Bioactive Fabric Sleeve', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'The Effect of a Bioactive Fabric Sleeve on Recovery in Division I Collegiate Baseball Players', 'orgStudyIdInfo': {'id': '72979'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioactive Sleeve then Control Sleeve', 'description': 'Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches', 'interventionNames': ['Device: Bioactive Sleeve', 'Device: Control Sleeve']}, {'type': 'EXPERIMENTAL', 'label': 'Control Sleeve then Bioactive Sleeve', 'description': 'Each pitcher will be instructed to sleep with the assigned sleeve on the throwing arm after each game that he pitches', 'interventionNames': ['Device: Bioactive Sleeve', 'Device: Control Sleeve']}], 'interventions': [{'name': 'Bioactive Sleeve', 'type': 'DEVICE', 'description': 'Pitchers will wear a bioactive sleeve immediately post-game through overnight.', 'armGroupLabels': ['Bioactive Sleeve then Control Sleeve', 'Control Sleeve then Bioactive Sleeve']}, {'name': 'Control Sleeve', 'type': 'DEVICE', 'description': 'Pitchers will wear a non-bioactive sleeve immediately post-game through overnight.', 'armGroupLabels': ['Bioactive Sleeve then Control Sleeve', 'Control Sleeve then Bioactive Sleeve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Michael Freehill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Challenger Health, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael T. Freehill', 'investigatorAffiliation': 'Stanford University'}}}}