Nctid:
NCT06616493
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2023-06-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-04-10", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"hip flexion/extension angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip flexion/extension angle in sagittal plane at the initial touchdown moment"}, {"measure"=>"hip varus/valgus angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip varus/valgus angle in frontal plane at the initial touchdown moment"}, {"measure"=>"hip external/internal rotation angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip external/internal rotation angle in transverse plane at the initial touchdown moment"}, {"measure"=>"knee flexion/extension angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee flexion/extension angle in sagittal plane at the initial touchdown moment"}, {"measure"=>"knee varus/valgus angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee varus/valgus angle in frontal plane at the initial touchdown moment"}, {"measure"=>"knee external/internal rotation angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee external/internal rotation angle in transverse plane at the initial touchdown moment"}, {"measure"=>"ankle dorsiflexion/plantarflexion angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle dorsiflexion/plantarflexion angle in sagittal plane at the initial touchdown moment"}, {"measure"=>"ankle varus/valgus angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle varus/valgus angle in frontal plane at the initial touchdown moment"}, {"measure"=>"ankle external/internal rotation angle at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle external/internal rotation angle in transverse plane at the initial touchdown moment"}, {"measure"=>"hip flexion/extension angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip flexion/extension angle in sagittal plane at the peak v-GRF moment"}, {"measure"=>"hip varus/valgus angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip varus/valgus angle in frontal plane at the peak v-GRFmoment"}, {"measure"=>"hip external/internal rotation angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip external/internal rotation angle in transverse plane at the peak v-GRF moment"}, {"measure"=>"knee varus/valgus angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee varus/valgus angle in frontal plane at the peak v-GRF moment"}, {"measure"=>"knee external/internal rotation angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee external/internal rotation angle in transverse plane at the peak v-GRF moment"}, {"measure"=>"knee flexion/extension angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee flexion/extension angle in sagittal plane at the peak v-GRF moment"}, {"measure"=>"ankle dorsiflexion/plantarflexion angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle dorsiflexion/plantarflexion angle in sagittal plane at the peak v-GRF moment"}, {"measure"=>"ankle external/internal rotation angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle external/internal rotation angle in transverse plane at the peak v-GRF moment"}, {"measure"=>"ankle varus/valgus angle at the peak vertical ground reaction force (v-GRF) moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle varus/valgus angle in frontal plane at the peak v-GRF moment"}, {"measure"=>"hip flexion/extension joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip flexion/extension joint torque in sagittal plane at the initial touchdown moment"}, {"measure"=>"hip varus/valgus joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip varus/valgus joint torque in the frontal plane at the initial touchdown moment"}, {"measure"=>"hip internal/external rotation joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip internal/external rotation joint torque in the transverse plane at the initial touchdown moment"}, {"measure"=>"knee flexion/extension joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee flexion/extension joint torque in sagittal plane at the initial touchdown moment"}, {"measure"=>"knee varus/valgus joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee varus/valgus joint torque in the frontal plane at the initial touchdown moment"}, {"measure"=>"knee internal/external rotation joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee internal/external rotation joint torque in the transverse plane at the initial touchdown moment"}, {"measure"=>"ankle dorsiflexion/plantarflexion joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee dorsiflexion/plantarflexion joint torque in sagittal plane at the initial touchdown moment"}, {"measure"=>"ankle varus/valgus joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle varus/valgus joint torque in the frontal plane at the initial touchdown moment"}, {"measure"=>"ankle internal/external rotation joint torque at the initial touchdown moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle internal/external rotation joint torque in the transverse plane at the initial touchdown moment"}, {"measure"=>"hip flexion/extension joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip flexion/extension joint torque in sagittal plane at thepeak v-GRFmoment"}, {"measure"=>"hip varus/valgus joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip varus/valgus joint torque in the frontal plane at the peak v-GRF moment"}, {"measure"=>"hip internal/external rotation joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"hip internal/external rotation joint torque in the transverse plane at the peak v-GRF moment"}, {"measure"=>"knee flexion/extension joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee flexion/extension joint torque in sagittal plane at the peak v-GRF moment"}, {"measure"=>"knee varus/valgus joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee varus/valgus joint torque in the frontal plane at the peak v-GRF moment"}, {"measure"=>"knee internal/external rotation joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"knee internal/external rotation joint torque in the transverse plane at the peak v-GRF moment"}, {"measure"=>"ankle dorsiflexion/plantarflexion joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle dorsiflexion/plantarflexion joint torque in sagittal plane at the peak v-GRF moment"}, {"measure"=>"ankle varus/valgus joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle varus/valgus joint torque in the frontal plane at the peak v-GRF moment"}, {"measure"=>"ankle internal/external rotation joint torque at the peak v-GRF moment", "timeFrame"=>"from enrollment to immediately after kinesio taping application", "description"=>"ankle internal/external rotation joint torque in the transverse plane at the peak v-GRF moment"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Effects of Kinesio Taping on Lower Extremity Biomechanical Characteristics"]}, "descriptionModule"=>{"briefSummary"=>"Knee joint is one of the most important joints of the human body. It plays a vital role in basketball, football, volleyball and other sports that need to do repeated jumping and landing in high-speed sports. However, the rate of knee joint injury is high in sports, and knee joint injury often occurs in single leg landing. It is related to the decrease of flexion angle of hip and knee joint on the supporting side, the increase of extension and valgus moment, and the increase of ground reaction force. Kinesio taping has been widely used in the field of sports protection in recent years, but whether it can correct injury-related biomechanical risk factors is still controversial, and there are few studies on the timeliness changes of kinesio taping. Therefore, starting from the above concerns, this study compares the differences in biomechanical characteristics of lower limb joints in knee joints under three conditions : kinesio taping, placebo taping and no taping. At the same time, the changes of biomechanical characteristics of lower limbs before and after taping were observed in order to provide reference for the application of knee joint kinesio taping in sports injury protection."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"24 years", "minimumAge"=>"21 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* between 18-25 years old;\n* BMI between 18.5-23.9kg/m2;\n* no injury history or surgery history in recent six months.\n\nExclusion Criteria:\n\n* kinesio taping allergy."}, "identificationModule"=>{"nctId"=>"NCT06616493", "briefTitle"=>"Tianjin University of Sport", "organization"=>{"class"=>"OTHER", "fullName"=>"Tianjin University of Sport"}, "officialTitle"=>"Tianjin University of Sport", "orgStudyIdInfo"=>{"id"=>"TJSport"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"KT", "description"=>"subjects with kinesio taping", "interventionNames"=>["Other: kinesio taping"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"placebo KT", "description"=>"subjects with placebo kinesio taping", "interventionNames"=>["Other: kinesio taping"]}, {"type"=>"NO_INTERVENTION", "label"=>"control", "description"=>"subjects with no kinesio taping"}], "interventions"=>[{"name"=>"kinesio taping", "type"=>"OTHER", "description"=>"measure the subjects' lower extremity biomechanical characteristics with 3 different conditions respectively (kinesio taping, placebo kinesio taping, no taping)", "armGroupLabels"=>["KT", "placebo KT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"301617", "city"=>"Tianjin", "state"=>"Tianjin", "country"=>"China", "facility"=>"Wei Zheng", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}], "overallOfficials"=>[{"name"=>"Wei Zheng", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Tianjin University of Sport, Tianjin, China"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tianjin University of Sport", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Vice dean of school of exercise and health, Tianjin University of Sport", "investigatorFullName"=>"Wei Zheng", "investigatorAffiliation"=>"Tianjin University of Sport"}}}}