Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-31 @ 12:17 AM
Study NCT ID:
NCT01784003
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-02-01', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Force-measuring treadmill and motion capture', 'timeFrame': 'approximately 2 months'}, {'measure': 'Metabolic analysis system', 'timeFrame': 'approximately 2 months'}]}, 'conditionsModule': {'conditions': ['Traumatic Amputation of Lower Extremity']}, 'referencesModule': {'references': [{'pmid': '25959113', 'type': 'RESULT', 'citation': 'Jeffers JR, Auyang AG, Grabowski AM. The correlation between metabolic and individual leg mechanical power during walking at different slopes and velocities. J Biomech. 2015 Aug 20;48(11):2919-24. doi: 10.1016/j.jbiomech.2015.04.023. Epub 2015 Apr 22.'}, {'pmid': '30225047', 'type': 'RESULT', 'citation': 'Montgomery JR, Grabowski AM. The contributions of ankle, knee and hip joint work to individual leg work change during uphill and downhill walking over a range of speeds. R Soc Open Sci. 2018 Aug 29;5(8):180550. doi: 10.1098/rsos.180550. eCollection 2018 Aug.'}, {'pmid': '28975280', 'type': 'RESULT', 'citation': 'Pickle NT, Grabowski AM, Jeffers JR, Silverman AK. The Functional Roles of Muscles, Passive Prostheses, and Powered Prostheses During Sloped Walking in People With a Transtibial Amputation. J Biomech Eng. 2017 Nov 1;139(11):1110051-11100511. doi: 10.1115/1.4037938.'}, {'pmid': '27553849', 'type': 'RESULT', 'citation': 'Pickle NT, Grabowski AM, Auyang AG, Silverman AK. The functional roles of muscles during sloped walking. J Biomech. 2016 Oct 3;49(14):3244-3251. doi: 10.1016/j.jbiomech.2016.08.004. Epub 2016 Aug 6.'}, {'pmid': '30158189', 'type': 'RESULT', 'citation': 'Montgomery JR, Grabowski AM. Use of a powered ankle-foot prosthesis reduces the metabolic cost of uphill walking and improves leg work symmetry in people with transtibial amputations. J R Soc Interface. 2018 Aug;15(145):20180442. doi: 10.1098/rsif.2018.0442.'}, {'type': 'RESULT', 'citation': 'Jeffers JR, Grabowski AM. Individual Leg and Joint Work during Sloped Walking for People with a Transtibial Amputation Using Passive and Powered Prostheses. Front. Robot. AI, 22 December 2017. https://doi.org/10.3389/frobt.2017.00072'}]}, 'descriptionModule': {'briefSummary': 'The proposed study aims to characterize biological ankle joint function during walking and running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle joint torque and angle data will be collected from non-amputees while walking and running at multiple speeds and slopes. This data will be used to develop control parameters for a powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a powered prosthesis worn by people with below the knee amputations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study 1: Non-amputee Study 2: Unilateral transtibial amputee Study 3: Unilateral transtibial amputee Study 4: Non-amputee Study 5: Unilateral transtibial amputee', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy 1:\n\n\\- Between 18-60 years old.\n\nStudy 2 and 3:\n\n* Between 18-60 years old.\n* At least 1 year post-amputation\n* no current problems with prosthesis or residual limb\n* At least a K3 level of ambulation\n\nStudy 4:\n\n\\- Between 18-45 years old\n\nStudy 5:\n\n* Between 18-45 years old\n* At least 1 year post-amputation\n* no current problems with prosthesis or residual limb\n* Experience running with a passive prosthesis\n* At least a K4 level of ambulation\n\nExclusion Criteria:\n\nStudies 1-5\n\n* Cardiovascular, pulmonary, or neurological disease or disorder\n* Musculoskeletal injury'}, 'identificationModule': {'nctId': 'NCT01784003', 'briefTitle': 'Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development', 'organization': {'class': 'FED', 'fullName': 'VA Eastern Colorado Health Care System'}, 'officialTitle': 'Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development', 'orgStudyIdInfo': {'id': 'A7972W'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-amputee', 'description': 'People without an amputation will be recruited to participate in the study.'}, {'label': 'Below the knee amputee', 'description': 'People with a unilateral transtibial amputation will be recruited to participate in the study.', 'interventionNames': ['Device: Powered ankle-foot prosthesis']}], 'interventions': [{'name': 'Powered ankle-foot prosthesis', 'type': 'DEVICE', 'armGroupLabels': ['Below the knee amputee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Eastern Colorado Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}