Nctid:
NCT06234202
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}}, "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"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-06", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-30", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06", "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"=>{"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"}}}}
