Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04070105
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2019-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
No Power Bionic Lower Extremity Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000673', 'term': 'Amputation, Traumatic'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gatesd@umich.edu', 'phone': '7346472698', 'title': 'Dr. Deanna Gates', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Six participants were enrolled and we built six feet for those individuals. Due to delays because of COVID pauses in human subjects testing, only five were available to test the final foot design. Of these, only three were able to run on a treadmill comfortably for five minutes.'}}, 'adverseEventsModule': {'timeFrame': 'During each of the three, approximately 4 hour, data collection sessions', 'eventGroups': [{'id': 'EG000', 'title': 'Prosthetic Foot Intervention', 'description': 'Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN)\n\nCompliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button\n\nConventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual\n\nCommercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed', 'description': 'This is a commercial prosthetic foot that has been prescribed to the individual'}, {'id': 'OG001', 'title': 'AllPro', 'description': 'This is a commercially available prosthetic foot designed for high-activity individuals'}, {'id': 'OG002', 'title': 'CAESAR', 'description': 'Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button'}], 'classes': [{'categories': [{'measurements': [{'value': '.175', 'spread': '0.043', 'groupId': 'OG000'}, {'value': '.166', 'spread': '0.022', 'groupId': 'OG001'}, {'value': '.166', 'spread': '0.013', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': "Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights.", 'unitOfMeasure': 'Body-weights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants walked with each of three feet: prescribed, CAESAR, and AllPro'}, {'type': 'PRIMARY', 'title': 'Participants Perceived Comfort When Using Different Prosthetic Feet During Walking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed', 'description': 'This is a commercial prosthetic foot that has been prescribed to the individual'}, {'id': 'OG001', 'title': 'AllPro', 'description': 'This is a commercially available prosthetic foot designed for high-activity individuals'}, {'id': 'OG002', 'title': 'CAESAR', 'description': 'Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button'}], 'classes': [{'categories': [{'measurements': [{'value': '84.8', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '80.6', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '77.4', 'spread': '23.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed', 'description': 'This is a commercial prosthetic foot that has been prescribed to the individual that they used for running. For some individuals this was a running foot, while for others it was not'}, {'id': 'OG001', 'title': 'AllPro', 'description': 'This is a commercially available prosthetic foot designed for high-activity individuals'}, {'id': 'OG002', 'title': 'CAESAR', 'description': 'Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button'}], 'classes': [{'categories': [{'measurements': [{'value': '0.093', 'spread': '0.006178', 'groupId': 'OG000'}, {'value': '0.079', 'spread': '0.005169', 'groupId': 'OG001'}, {'value': '.154', 'spread': '0.004942', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants will run on a treadmill with force sensors below the treadmill belt. Data will be measured in Newtons and then normalized by dividing by body weight.', 'unitOfMeasure': 'Body-weights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants ran with each of three feet: prescribed, CAESAR, and AllPro'}, {'type': 'SECONDARY', 'title': 'Net V02 (Metabolic Cost) During Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed', 'description': 'This is a commercial prosthetic foot that has been prescribed to the individual that they used for running. For some individuals this was a running foot, while for others it was not'}, {'id': 'OG001', 'title': 'AllPro', 'description': 'This is a commercially available prosthetic foot designed for high-activity individuals'}, {'id': 'OG002', 'title': 'CAESAR', 'description': 'Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button'}], 'classes': [{'categories': [{'measurements': [{'value': '25.66', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '26.86', 'spread': '2.99', 'groupId': 'OG001'}, {'value': '27.68', 'spread': '2.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who could run comfortably on the treadmill for 5 minutes with that foot'}, {'type': 'PRIMARY', 'title': 'Participants Perceived Comfort When Using Different Prosthetic Feet During Running', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed', 'description': 'This is a commercial prosthetic foot that has been prescribed to the individual'}, {'id': 'OG001', 'title': 'AllPro', 'description': 'This is a commercially available prosthetic foot designed for high-activity individuals'}, {'id': 'OG002', 'title': 'CAESAR', 'description': 'Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button'}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '66.4', 'spread': '36.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who ran in the lab with each foot style. One participant did not complete the survey with his prescribed foot'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAESAR, Then Prescribed, Then AllPro', 'description': 'Participants will walk and run with three prostheses in random order'}, {'id': 'FG001', 'title': 'CAESAR, Then AllPro, Then Prescribed', 'description': 'Participants will walk and run with three prostheses in random order'}, {'id': 'FG002', 'title': 'Prescribed, Then AllPro, Then CAESAR', 'description': 'Participants will walk and run with three prostheses in random order'}, {'id': 'FG003', 'title': 'Prescribed, Then CAESAR, Then AllPro', 'description': 'Participants will walk and run with three prostheses in random order'}, {'id': 'FG004', 'title': 'AllPro, Then CAESAR, Then Prescribed', 'description': 'Participants will walk and run with three prostheses in random order'}, {'id': 'FG005', 'title': 'AllPro, Then Prescribed, Then CAESAR', 'description': 'Participants will walk and run with three prostheses in random order'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants enrolled in the study and tested a prototype foot to assess stiffness. A foot was then manufactured for them specifically. Due to COVID19 pauses in collection there was a significant gap between manufacturing the prosthetic feet and human subjects testing. One participant was no longer available to complete laboratory testing. The order of testing was randomized between participants, such that all participants completed testing in a different order.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Prosthetic Foot Intervention', 'description': 'Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN)\n\nCompliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button\n\nConventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual\n\nCommercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48.7', 'spread': '14.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height (m)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'spread': '8.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-05', 'size': 239445, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-05T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2019-08-20', 'resultsFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-29', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': "Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights."}, {'measure': 'Participants Perceived Comfort When Using Different Prosthetic Feet During Walking', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)'}, {'measure': 'Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants will run on a treadmill with force sensors below the treadmill belt. Data will be measured in Newtons and then normalized by dividing by body weight.'}, {'measure': 'Participants Perceived Comfort When Using Different Prosthetic Feet During Running', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)'}], 'secondaryOutcomes': [{'measure': 'Net V02 (Metabolic Cost) During Running', 'timeFrame': 'All conditions were complete during 3 lab visits, approximately four hours long', 'description': 'Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amputation', 'Amputation, Traumatic', 'Amputation; Traumatic, Leg, Lower']}, 'descriptionModule': {'briefSummary': "Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.", 'detailedDescription': "Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active. Here we will test this device to determine how it affects the user's mechanics during running and walking. Participants will come to a research laboratory for three test sessions where they will run and walk in their current foot, a commercial high-activity foot, and the prototype CAESAR foot."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Population:\n\nInclusion Criteria:\n\n* At least 18 years old\n* Transtibial amputation of one or both legs\n* Classified as K3 or K4 on the Medicare Functional Classification Level\n* Use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months\n* Able to walk and run without assistance\n\nExclusion Criteria:\n\n* Significant injury to intact limb\n* History of balance impairments or neurologic disorders\n* Significant cardiovascular or respiratory disease'}, 'identificationModule': {'nctId': 'NCT04070105', 'briefTitle': 'No Power Bionic Lower Extremity Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'No Power Bionic Lower Extremity Prosthesis', 'orgStudyIdInfo': {'id': 'HUM00150407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAESAR Foot, Prescribed Feet, AllPro', 'description': 'Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, Prescribed Feet, AllPro.', 'interventionNames': ['Device: Compliant Adaptive Energy Storage and Return Foot', 'Device: AllPro']}, {'type': 'EXPERIMENTAL', 'label': 'CAESAR Foot, AllPro, Prescribed Feet', 'description': 'Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is CAESAR Foot, AllPro, Prescribed Feet', 'interventionNames': ['Device: Compliant Adaptive Energy Storage and Return Foot', 'Device: AllPro']}, {'type': 'EXPERIMENTAL', 'label': 'Prescribed Feet, AllPro, CAESAR Foot', 'description': 'Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, AllPro, CAESAR Foot', 'interventionNames': ['Device: Compliant Adaptive Energy Storage and Return Foot', 'Device: AllPro']}, {'type': 'EXPERIMENTAL', 'label': 'Prescribed Feet, CAESAR Foot, AllPro', 'description': 'Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is Prescribed Feet, CAESAR Foot, AllPro', 'interventionNames': ['Device: Compliant Adaptive Energy Storage and Return Foot', 'Device: AllPro']}, {'type': 'EXPERIMENTAL', 'label': 'AllPro, Prescribed Feet, CAESAR Foot', 'description': 'Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, Prescribed Feet, CAESAR Foot', 'interventionNames': ['Device: Compliant Adaptive Energy Storage and Return Foot', 'Device: AllPro']}, {'type': 'EXPERIMENTAL', 'label': 'AllPro, CAESAR Foot, Prescribed Feet,', 'description': 'Participants will walk and run with different prostheses on different days in a laboratory. The order of testing is AllPro, CAESAR Foot, Prescribed Feet', 'interventionNames': ['Device: Compliant Adaptive Energy Storage and Return Foot', 'Device: AllPro']}], 'interventions': [{'name': 'Compliant Adaptive Energy Storage and Return Foot', 'type': 'DEVICE', 'otherNames': ['CAESAR Foot'], 'description': 'The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button', 'armGroupLabels': ['AllPro, CAESAR Foot, Prescribed Feet,', 'AllPro, Prescribed Feet, CAESAR Foot', 'CAESAR Foot, AllPro, Prescribed Feet', 'CAESAR Foot, Prescribed Feet, AllPro', 'Prescribed Feet, AllPro, CAESAR Foot', 'Prescribed Feet, CAESAR Foot, AllPro']}, {'name': 'AllPro', 'type': 'DEVICE', 'description': 'Participants will be fit with a high activity foot designed to be used for walking and running', 'armGroupLabels': ['AllPro, CAESAR Foot, Prescribed Feet,', 'AllPro, Prescribed Feet, CAESAR Foot', 'CAESAR Foot, AllPro, Prescribed Feet', 'CAESAR Foot, Prescribed Feet, AllPro', 'Prescribed Feet, AllPro, CAESAR Foot', 'Prescribed Feet, CAESAR Foot, AllPro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Deanna H Gates', 'investigatorAffiliation': 'University of Michigan'}}}}