Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04748718
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2021-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Serial Movement Assessment in Collegiate Athletes Who Perform Injury Prevention Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D001265', 'term': 'Athletic Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Eleanor.Beltz@NorthernVermont.edu', 'phone': '802-635-1329', 'title': 'Dr. Eleanor Beltz', 'organization': 'Northern Vermont University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'through study completion, an average of 7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Injury Prevention Arm', 'description': 'Exercise-based injury prevention program: \\~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Landing Error Scoring System (LESS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Injury Prevention Arm', 'description': 'Exercise-based injury prevention program: \\~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '6', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'midseason', 'categories': [{'measurements': [{'value': '5.8', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'end-of-season', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)', 'description': 'number of errors; scale is 0-17; lower score indicates better outcome', 'unitOfMeasure': 'errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Balance Error Scoring System (BESS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Injury Prevention Arm', 'description': 'Exercise-based injury prevention program: \\~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '28.6', 'spread': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'midseason', 'categories': [{'measurements': [{'value': '22.5', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'end-of-season', 'categories': [{'measurements': [{'value': '25.9', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)', 'description': 'number of errors; scale is 0-60; higher score indicates worse outcome', 'unitOfMeasure': 'errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'complete data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Injury Prevention Arm', 'description': 'Exercise-based injury prevention program: \\~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Injury Prevention Arm', 'description': 'Exercise-based injury prevention program: \\~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'height', 'classes': [{'categories': [{'measurements': [{'value': '180.3', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'mass', 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-28', 'size': 102757, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-28T11:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2021-01-31', 'resultsFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-29', 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Landing Error Scoring System (LESS) Score', 'timeFrame': 'assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)', 'description': 'number of errors; scale is 0-17; lower score indicates better outcome'}, {'measure': 'Balance Error Scoring System (BESS) Score', 'timeFrame': 'assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)', 'description': 'number of errors; scale is 0-60; higher score indicates worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sport injury', 'injury prevention', 'neuromuscular control'], 'conditions': ['Injury Leg', 'Injury, Knee', 'Injury;Sports', 'Injury, Ankle']}, 'descriptionModule': {'briefSummary': 'Athletic injury can result in decreased athletic performance or removal from sport participation. There may also be psychological and financial impacts of athletic injury. Additionally, there can be long-term consequences, such as increased risk of subsequent injury or arthritis. Therefore, determining ways to prevent athletic injury from occurring is critical. Movement quality during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Movement quality can be improved through exercise-based injury prevention training, thereby decreasing injury risk. This purposed of this study is to evaluate movement quality multiple times over the course of an athletic season in collegiate athletes who perform injury prevention training. The hypothesis is that movement quality will improve over the course of an athletic season.', 'detailedDescription': "Neuromuscular control, or quality of movement, during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Neuromuscular control can be improved through exercise-based injury prevention training (called preventive training programs, or PTPs), thereby decreasing injury risk. Neuromuscular control is dynamic and therefore should be evaluated regularly; however, no study has serially evaluated neuromuscular control in athletes who perform PTPs. The overall objective of the proposed study is to longitudinally evaluate multiple aspects of neuromuscular control (i.e., movement quality, balance) across several time points during a single athletic season in collegiate athletes who perform PTPs. Therefore, two specific aims are proposed: Specific Aim 1: Evaluate neuromuscular control at multiple time points during an athletic season in collegiate athletes who perform PTPs. Specific Aim 2: Evaluate multiple measures of neuromuscular control over the course of an athletic season in collegiate athletes who perform PTPs. A field-based, experimental, cohort study will be used to address both specific aims. Subjects will be recruited from NCAA-Division III men's and women's soccer, volleyball and basketball teams. Neuromuscular control will be assessed four times during the athletic season using the Landing Error Scoring System (LESS), the Balance Error Scoring System (BESS), and the Star Excursion Balance Test (SEBT). The LESS evaluates movement quality, while the BESS and the SEBT evaluate static and dynamic balance, respectively. Subjects will perform PTPs for about 10 minutes/day, at least 4 days/week."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* National Collegiate Athletics Association (NCAA) Division III Athlete\n* Coach and athletic trainer elect to receive injury prevention services\n* Ages 18-24\n\nExclusion Criteria:\n\n-Does not participate on NCAA Division III Athletic Team'}, 'identificationModule': {'nctId': 'NCT04748718', 'briefTitle': 'Serial Movement Assessment in Collegiate Athletes Who Perform Injury Prevention Training', 'organization': {'class': 'OTHER', 'fullName': 'Northern Vermont University'}, 'officialTitle': 'Serial Movement Assessment in Athletes Who Perform Injury Prevention Training', 'orgStudyIdInfo': {'id': 'Beltz FAW2122 NMC PTP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injury Prevention Arm', 'description': 'exercise-based neuromuscular training injury prevention program', 'interventionNames': ['Other: Exercise-based injury prevention program']}], 'interventions': [{'name': 'Exercise-based injury prevention program', 'type': 'OTHER', 'description': '\\~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.', 'armGroupLabels': ['Injury Prevention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05665', 'city': 'Johnson', 'state': 'Vermont', 'country': 'United States', 'facility': 'Northern Vermont University', 'geoPoint': {'lat': 44.63561, 'lon': -72.6804}}], 'overallOfficials': [{'name': 'Eleanor Beltz, PhD, ATC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern Vermont University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Vermont University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eleanor Beltz', 'investigatorAffiliation': 'Northern Vermont University'}}}}