Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02495792
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2015-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using Real Time Biofeedback to Alter Running Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamie.b.morris.mil@mail.mil', 'phone': '210-221-3700', 'title': 'MAJ Jamie Morris', 'organization': 'Brooke Army Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Group does not receive the biofeedback sensor', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biofeedback Group', 'description': 'Group does receive the biofeedback sensor\n\nBiofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock', 'otherNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Foot Strike Pattern From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Group does not receive the biofeedback sensor'}, {'id': 'OG001', 'title': 'Biofeedback Group', 'description': 'Group does receive the biofeedback sensor\n\nBiofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock'}], 'classes': [{'title': 'Post-Training', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post-training, 6mo post-training, and 1yr post-training', 'description': 'Foot strike pattern will be either classified as rearfoot strike or non-rearfoot strike. This is determined by video analysis of 240hz camera. All participants baseline foot strike pattern was rearfoot at study enrollment.', 'unitOfMeasure': 'percentage of non-rearfoot strike patter', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Injury Incidence Between Foot Strike Patterns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rearfoot Strike Pattern', 'description': 'Runners that have initial foot contact as rearfoot strike'}, {'id': 'OG001', 'title': 'Non-rearfoot Strike Pattern', 'description': 'Runners with an initial foot contact of non-rearfoot strike'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1yr', 'description': 'Percentage of runners that became injured over 1 yr. Injury defined as pain in the lower extremity that caused restriction or stoppage of running for at least one week, or required the runner to consult a physician or other health care professional.', 'unitOfMeasure': 'percentage of injured runners', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relative Risk of Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rearfoot Strike Pattern (RFS)', 'description': 'Runners that have initial foot contact as rearfoot strike'}, {'id': 'OG001', 'title': 'Non-rearfoot Strike Pattern (NRFS)', 'description': 'Runners with an initial foot contact of non-rearfoot strike'}], 'classes': [{'categories': [{'title': 'Developed knee pain', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Did not develop knee pain', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.98', 'ciLowerLimit': '1.6', 'ciUpperLimit': '21.7', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1yr', 'description': 'Risk of runner to develop a knee injury based on foot-strike pattern', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Group does not receive the biofeedback sensor'}, {'id': 'FG001', 'title': 'Biofeedback Group', 'description': 'Group does receive the biofeedback sensor\n\nBiofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Group does not receive the biofeedback sensor'}, {'id': 'BG001', 'title': 'Biofeedback Group', 'description': 'Group does receive the biofeedback sensor\n\nBiofeedback Sensor: Tibia accelerometer strapped to distal tibia to detect tibial shock'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '25.7', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '174.9', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '174', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '75.8', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '75.1', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weekly Mileage', 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '22.9', 'spread': '14', 'groupId': 'BG001'}, {'value': '23.3', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilometers per Week', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2015-05-25', 'resultsFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-04', 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Foot Strike Pattern From Baseline', 'timeFrame': 'Immediately post-training, 6mo post-training, and 1yr post-training', 'description': 'Foot strike pattern will be either classified as rearfoot strike or non-rearfoot strike. This is determined by video analysis of 240hz camera. All participants baseline foot strike pattern was rearfoot at study enrollment.'}], 'secondaryOutcomes': [{'measure': 'Injury Incidence Between Foot Strike Patterns', 'timeFrame': '1yr', 'description': 'Percentage of runners that became injured over 1 yr. Injury defined as pain in the lower extremity that caused restriction or stoppage of running for at least one week, or required the runner to consult a physician or other health care professional.'}, {'measure': 'Relative Risk of Injury', 'timeFrame': '1yr', 'description': 'Risk of runner to develop a knee injury based on foot-strike pattern'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are 1) to assess foot strike patterns initially, at six months and at one year between two groups of runners attempting to transition to a non-rearfoot strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between the age of 18 - 50 years\n2. Run on average 12mi per week\n3. DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment\n4. Read and speak English well enough to provide informed consent and follow study instructions\n\nExclusion Criteria:\n\n1. Known pregnancy currently or in the previous 6 months\n2. Lower extremity or low back pain in the previous 3 months\n3. Lower extremity or low back surgery in the previous 6 months\n4. Any lower extremity or low back exercise limiting profile\n5. Previous stress fracture of the foot\n6. Participant who has a non-rearfoot strike running pattern'}, 'identificationModule': {'nctId': 'NCT02495792', 'briefTitle': 'Using Real Time Biofeedback to Alter Running Mechanics', 'organization': {'class': 'FED', 'fullName': 'Keller Army Community Hospital'}, 'officialTitle': 'Using Real Time Biofeedback to Alter Running Biomechanics', 'orgStudyIdInfo': {'id': '404239-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group does not receive the biofeedback sensor'}, {'type': 'EXPERIMENTAL', 'label': 'Biofeedback group', 'description': 'Group does receive the biofeedback sensor', 'interventionNames': ['Device: Biofeedback Sensor']}], 'interventions': [{'name': 'Biofeedback Sensor', 'type': 'DEVICE', 'description': 'Tibia accelerometer strapped to distal tibia to detect tibial shock', 'armGroupLabels': ['Biofeedback group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jamie B Morris, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keller Army Community Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keller Army Community Hospital', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapy Sports Medicine Fellow', 'investigatorFullName': 'Jamie Morris', 'investigatorAffiliation': 'Keller Army Community Hospital'}}}}