Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-05 @ 6:46 PM
Study NCT ID:
NCT01404559
Status:
COMPLETED
Last Update Posted:
2014-12-15
First Post:
2011-05-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wquillen@health.usf.edu', 'phone': '8139749863', 'title': 'William S. Quillen', 'organization': 'University of South Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Control subjects were not determined to be at risk given that they were not exposed to an intervention and the activities used to measure performance are routine in their daily work and activities.', 'eventGroups': [{'id': 'EG000', 'title': 'Unilateral Transtibial Amputees', 'description': 'This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Obstacle Course Completion Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prosthetic Foot 1 (Ossur Variflex)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.\n\nOssur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot'}, {'id': 'OG001', 'title': 'Prosthetic Foot 2 (Ossur Ceterus)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.\n\nOssur Ceterus prosthetic foot: Shock-absorbing prosthetic foot'}, {'id': 'OG002', 'title': 'Prosthetic Foot 3 (Endolite Elite Blade)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.\n\nEndolite Elite Blade prosthetic foot: Multi-axial prosthetic foot'}, {'id': 'OG003', 'title': 'Non-amputee Controls', 'description': 'This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.\n\nNo intervention. Control group.: There are no interventions in this observational arm of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '425', 'spread': '144', 'groupId': 'OG000'}, {'value': '444', 'spread': '220', 'groupId': 'OG001'}, {'value': '419', 'spread': '130', 'groupId': 'OG002'}, {'value': '287', 'spread': '58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days total (7days per prosthetic foot condition)', 'description': 'Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Bioenergetics Between Feet Components 21 Days After Fitting Prostheses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prosthetic Foot 1 (Ossur Variflex)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.\n\nOssur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot'}, {'id': 'OG001', 'title': 'Prosthetic Foot 2 (Ossur Ceterus)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.\n\nOssur Ceterus prosthetic foot: Shock-absorbing prosthetic foot'}, {'id': 'OG002', 'title': 'Prosthetic Foot 3 (Endolite Elite Blade)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.\n\nEndolite Elite Blade prosthetic foot: Multi-axial prosthetic foot'}, {'id': 'OG003', 'title': 'Non-amputee Controls', 'description': 'This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.\n\nNo intervention. Control group.: There are no interventions in this observational arm of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '15.57', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '15.05', 'spread': '2.17', 'groupId': 'OG002'}, {'value': '11.05', 'spread': '1.89', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days total (7days per prosthetic foot condition)', 'description': 'Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.', 'unitOfMeasure': 'ml O2/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prosthetic Foot 1 (Ossur Variflex)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).\n\nOssur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot'}, {'id': 'FG001', 'title': 'Prosthetic Foot 2 (Ossur Ceterus)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).\n\nOssur Ceterus prosthetic foot: Shock-absorbing prosthetic foot'}, {'id': 'FG002', 'title': 'Prosthetic Foot 3 (Endolite Elite Blade)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).\n\nEndolite Elite Blade prosthetic foot: Multi-axial prosthetic foot'}, {'id': 'FG003', 'title': 'Non-amputee Controls', 'description': 'This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.\n\nNo intervention. Control group.: There are no interventions in this observational arm of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transtibial Amputees', 'description': 'This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.'}, {'id': 'BG001', 'title': 'Non-amputee Controls', 'description': 'This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.\n\nNo intervention. Control group.: There are no interventions in this observational arm of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2011-05-31', 'resultsFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-04', 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obstacle Course Completion Time', 'timeFrame': '21 days total (7days per prosthetic foot condition)', 'description': 'Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.'}, {'measure': 'Bioenergetics Between Feet Components 21 Days After Fitting Prostheses', 'timeFrame': '21 days total (7days per prosthetic foot condition)', 'description': 'Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amputee', 'Transtibial', 'Military', 'Gait', 'Rehabilitation'], 'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': 'Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.', 'detailedDescription': 'Specific Aims\n\n* Compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments.\n* Compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups.\n\nHypotheses:\n\nProsthetic feet with shock absorbing and torsional features will perform better in field activities. Prosthetic feet with high energy return and low mass will perform better during treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects.\n\nRelevance:\n\nThis study has the potential to quantify differences between highly mobile amputees and non-amputees. Additionally, it will provide objective measures of how different prostheses may enhance mobility of soldiers with amputations. The study will compare laboratory and field measures to indicate which conditions increase efficiency of prostheses during rapidly changing mobility demands. This has the potential to permit retention of already trained soldiers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Amputees):\n\n* Unilateral transtibial amputee ambulating on a K4 prosthesis for \\>1yr\n* K4 functional level\n* Currently active duty military or other uniformed service (e.g. police), recently separated Veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.)\n* Schedule availability and willingness to comply with study protocols\n* Aged \\< 45 years\n* Medical clearance, within the last 6 months, for participation in vigorous physical activities\n\nInclusion Criteria (Non-amputees)\n\n* Currently active duty military, ROTC, or other uniformed service (e.g. police) or recently separated Veteran, or highly accomplished recreational athlete (e.g. marathoner)\n* Schedule availability and willingness to comply with study protocols\n* Aged \\< 45 years\n* Medical clearance, within the last 6 months, for participation in vigorous physical activities'}, 'identificationModule': {'nctId': 'NCT01404559', 'briefTitle': 'Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Metabolic and Biomechanical Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities', 'orgStudyIdInfo': {'id': '10193006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prosthetic foot 1 (Ossur Variflex)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).', 'interventionNames': ['Device: Ossur Variflex prosthetic foot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prosthetic foot 2 (Ossur Ceterus)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus).', 'interventionNames': ['Device: Ossur Ceterus prosthetic foot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prosthetic foot 3 (Endolite Elite Blade)', 'description': 'This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade).', 'interventionNames': ['Device: Endolite Elite Blade prosthetic foot']}, {'type': 'NO_INTERVENTION', 'label': 'Non-amputee controls', 'description': 'This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.'}], 'interventions': [{'name': 'Ossur Variflex prosthetic foot', 'type': 'DEVICE', 'description': 'Lightweight energy-storing prosthetic foot', 'armGroupLabels': ['Prosthetic foot 1 (Ossur Variflex)']}, {'name': 'Ossur Ceterus prosthetic foot', 'type': 'DEVICE', 'description': 'Shock-absorbing prosthetic foot', 'armGroupLabels': ['Prosthetic foot 2 (Ossur Ceterus)']}, {'name': 'Endolite Elite Blade prosthetic foot', 'type': 'DEVICE', 'description': 'Multi-axial prosthetic foot', 'armGroupLabels': ['Prosthetic foot 3 (Endolite Elite Blade)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'William S Quillen, PT,DPT,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}, {'name': 'M. Jason Highsmith, PT,DPT,CP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of South Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean & Professor', 'investigatorFullName': 'William Quillen', 'investigatorAffiliation': 'University of South Florida'}}}}