Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02601456
Status:
UNKNOWN
Last Update Posted:
2017-10-17
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000673', 'term': 'Amputation, Traumatic'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-14', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes in step length asymmetry after prolonged effort in running on a treadmill.', 'timeFrame': 'Several measurements during 20-30 minutes run.', 'description': 'Step length will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}, {'measure': 'The changes in contact time asymmetry after prolonged effort in running on a treadmill.', 'timeFrame': 'Several measurements during 30 minutes run.', 'description': 'Contact time will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}, {'measure': 'The changes in flight time asymmetry after prolonged effort in running on a treadmill.', 'timeFrame': 'Several measurements during 30 minutes run.', 'description': 'Flight time will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}, {'measure': 'The changes in hip angles asymmetry after prolonged effort in running on a treadmill.', 'timeFrame': 'Several measurements during 30 minutes run.', 'description': 'Hip angles will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}, {'measure': 'The changes in knee angles asymmetry after prolonged effort in running on a treadmill.', 'timeFrame': 'Several measurements during 30 minutes run.', 'description': 'Knee angles will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}, {'measure': 'The changes in vertical ground reaction force asymmetry after prolonged effort in running. on a treadmill', 'timeFrame': 'Several measurements during 30 minutes run.', 'description': 'Vertical ground reaction force will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}, {'measure': 'The changes in ground reaction impulse asymmetry after prolonged effort in running on a treadmill.', 'timeFrame': 'Several measurements during 30 minutes run.', 'description': 'Vertical ground reaction impulse will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amputation, Traumatic', 'Biomechanics', 'Asymmetry', 'Amputee Running', 'Prolonged Effort'], 'conditions': ['Amputation, Traumatic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of prolonged effort in long distance running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee running with running specific prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral traumatic trans tibial amputee.\n* Experience in running with running specific prosthesis.\n* Ability to run for at least 20 minutes.\n\nExclusion Criteria:\n\n* Injury or other orthopedic or neurologic issue that compromises the gait.'}, 'identificationModule': {'nctId': 'NCT02601456', 'briefTitle': 'Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effect of Prolonged Effort on the Bilateral Asymmetry in Trans Tibial Amputee Running With Running Specific Prosthesis', 'orgStudyIdInfo': {'id': 'SHEBA-14-1834-ISN-CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Itzhak Ziev-Ner, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}