Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-03 @ 5:54 PM
Study NCT ID:
NCT02921295
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2016-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis
Sponsor:
Organization:
Raw JSON
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The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.', 'unitOfMeasure': 'm/s', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Timed up and go Test Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stubbies', 'description': 'control intervention'}, {'id': 'OG001', 'title': 'Sidekicks', 'description': 'active intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.0103', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.0074', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 times throughout study completion (3 every 1 hour during the 2 hour protocol)', 'description': 'The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.', 'unitOfMeasure': 's', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gait Symmetry Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stubbies', 'description': 'Control intervention'}, {'id': 'OG001', 'title': 'Sidekicks', 'description': 'active intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '1.046', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '0.965', 'spread': '0.113', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 times throughout study completion (every 1 hour during the 2 hour protocol)', 'description': 'Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequential Change of Intervention', 'description': 'Conventional Stubby prostheses and Sidekicks prostheses were used in a randomized sequence'}], 'periods': [{'title': 'Sidekicks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Conventional Prostheses', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequential Change of Interventions', 'description': 'Conventional Stubby prostheses will be used in this intervention'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', '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': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-27', 'size': 62130, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-19T11:53', 'hasProtocol': False}, {'date': '2016-09-27', 'size': 2314411, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-03-26T15:32', 'hasProtocol': False}, {'date': '2016-09-27', 'size': 294914, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-23T15:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-23', 'studyFirstSubmitDate': '2016-09-29', 'resultsFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-23', 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Speed for 10 Meter Walk Test', 'timeFrame': '2 times throughout study completion (every 1 hour during the 2 hour protocol)', 'description': 'The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.'}], 'secondaryOutcomes': [{'measure': 'Timed up and go Test Time', 'timeFrame': '6 times throughout study completion (3 every 1 hour during the 2 hour protocol)', 'description': 'The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.'}, {'measure': 'Gait Symmetry Index', 'timeFrame': '2 times throughout study completion (every 1 hour during the 2 hour protocol)', 'description': 'Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.'}]}, 'conditionsModule': {'conditions': ['Amputation Stumps']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral transfemoral amputee\n* own a pair of conventional stubby prosthesis with standard adaptation\n\nExclusion Criteria:\n\n* dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)\n* use of prosthesis that do not allow change of feet with standard adapters\n* any medical condition that may put an individual in greater risk of injury than normal daily activity.'}, 'identificationModule': {'nctId': 'NCT02921295', 'briefTitle': 'A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'orgStudyIdInfo': {'id': 'PRO16050355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sidekick Stubbies', 'description': 'Conventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses ("Sidekick" manufactured by College Park Ind.) were used as intervention', 'interventionNames': ['Device: Sidekick Stubbies']}], 'interventions': [{'name': 'Sidekick Stubbies', 'type': 'DEVICE', 'armGroupLabels': ['Sidekick Stubbies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bakery Square MSPO labs', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angela DeCandia', 'class': 'OTHER'}, 'collaborators': [{'name': 'College Park Industries', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prosthetic & Orthotic Resident', 'investigatorFullName': 'Angela DeCandia', 'investigatorAffiliation': 'University of Pittsburgh'}}}}