Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02864693
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2016-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-09-10', 'releaseDate': '2019-08-21'}], 'estimatedResultsFirstSubmitDate': '2019-08-21'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-09', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amputee Mobility Predictor with Prosthesis (AMPPRO)', 'timeFrame': 'Collection at baseline', 'description': 'The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability'}, {'measure': 'L-Functional Test (L-Test) Baseline', 'timeFrame': 'Collection at baseline', 'description': 'The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.'}, {'measure': '5 times Sit-to-Stand (5 times STS) Baseline', 'timeFrame': 'Collection at baseline', 'description': 'The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.'}, {'measure': '6 minute Timed Walk Test (6m TWT) Baseline', 'timeFrame': 'Collection at baseline', 'description': 'The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.'}, {'measure': 'Physiological Cost Index (PCI) Baseline', 'timeFrame': 'Collection at baseline', 'description': 'The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.'}, {'measure': 'Hill Assessment Index (HAI) Baseline', 'timeFrame': 'Collection at baseline', 'description': 'The HAI is a functional test that measures quality of walking up and down a sloped ramp.'}, {'measure': '2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline', 'timeFrame': 'Collection at baseline', 'description': '2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.'}, {'measure': 'L-Functional Test (L-Test) after 4 weeks', 'timeFrame': 'Collection after 4 weeks', 'description': 'The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.'}, {'measure': '5 times Sit-to-Stand (5 times STS) after 4 weeks', 'timeFrame': 'Collection after 4 weeks', 'description': 'The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.'}, {'measure': '6 minute Timed Walk Test (6m TWT) after 4 weeks', 'timeFrame': 'Collection after 4 weeks', 'description': 'The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.'}, {'measure': 'Physiological Cost Index (PCI) after 4 weeks', 'timeFrame': 'Collection after 4 weeks', 'description': 'The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.'}, {'measure': 'Hill Assessment Index (HAI) after 4 weeks', 'timeFrame': 'Collection after 4 weeks', 'description': 'The HAI is a functional test that measures quality of walking up and down a sloped ramp.'}, {'measure': '2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks', 'timeFrame': 'Collection after 4 weeks', 'description': '2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.'}], 'secondaryOutcomes': [{'measure': 'Orthotic Prosthetic User Survey (OPUS)', 'timeFrame': 'Collection after 4 weeks', 'description': 'The OPUS is a self-reported questionnaire that asks about satisfaction with device'}, {'measure': 'Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)', 'timeFrame': 'Collection after 4 weeks', 'description': 'The PEQ-MS is a self-reported questionnaire that measures perceived difficulty ambulating on a variety of environmental barriers'}, {'measure': 'Prosthesis Limb User Survey of Mobility (PLUS-M)', 'timeFrame': 'Collection after 4 weeks', 'description': 'The PLUS-M is a self-reported questionnaire that measures perceived mobility with a prosthesis in different environments.'}, {'measure': 'Activities-Specific Balance Confidence Scale (ABC)', 'timeFrame': 'Collection after 4 weeks', 'description': 'The ABC is a self-reported questionnaire that measures confidence in balance while performing various activities in different environments.'}, {'measure': 'Socket Comfort Score (SCS)', 'timeFrame': 'Collection at baseline and after 4 weeks', 'description': 'The SCS is a self-reported questionnaire that asks the participant to rate their current socket comfort from 0-10, with 10 points representing the most comfortable socket they can imagine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Microprocessor Controlled Ankle', 'Transtibial Amputee', 'Pacifica LP', 'Kinnex'], 'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.', 'detailedDescription': 'Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited.\n\nIn this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral transtibial amputation\n* Age 18-99 years old\n* Body weight below 275 lbs\n* Non-pregnant\n* English speaking\n* Current user of prosthesis for at least one year\n* Wear time 8 hrs/day or more\n* MFCL ≥ K-3\n* Well-fitting and functioning prosthesis\n* No use of ambulatory aide\n* Able to tolerate testing protocol\n* Able to walk on slopes\n* Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments\n\nExclusion Criteria:\n\n* Amputation level other than unilateral transtibial\n* Age \\<18 or \\>99 years old\n* Body weight above 275 lbs\n* Pregnant\n* Non-English speaking\n* Not current user of prosthesis\n* Less than one year use of prosthesis\n* Wear time less than 8 hr/day\n* MFCL \\<K3\n* Poor fitting and functioning prosthesis\n* Indicating that the socket fit is painful, or unacceptable\n* Use of ambulatory aide\n* Unable to tolerate testing protocol\n* Unable to walk on slopes\n* Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study\n* Any neurologic impairments known to cause gait and/or balance dysfunction'}, 'identificationModule': {'nctId': 'NCT02864693', 'briefTitle': 'Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ability Prosthetics and Orthotics, Inc.'}, 'officialTitle': 'Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation', 'orgStudyIdInfo': {'id': 'FI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Configuration A (Kinnex)', 'interventionNames': ['Device: Kinnex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Configuration B (Pacifica LP)', 'interventionNames': ['Device: Pacifica LP']}], 'interventions': [{'name': 'Kinnex', 'type': 'DEVICE', 'description': 'The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).', 'armGroupLabels': ['Configuration A (Kinnex)']}, {'name': 'Pacifica LP', 'type': 'DEVICE', 'description': 'The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)', 'armGroupLabels': ['Configuration B (Pacifica LP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Ability Prosthetics and Orthotics, Inc. - Charlotte, NC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Ability Prosthetics and Orthotics, Inc. - York, PA', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ability Prosthetics and Orthotics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Outcome and Research Director', 'investigatorFullName': 'Brian Kaluf BSE, CP', 'investigatorAffiliation': 'Ability Prosthetics and Orthotics, Inc.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-08-21', 'type': 'RELEASE'}, {'date': '2019-09-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Brian Kaluf BSE, CP, Clinical Outcome and Research Director, Ability Prosthetics and Orthotics, Inc.'}}}}