Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-10 @ 7:57 AM
Study NCT ID:
NCT06115161
Status:
WITHDRAWN
Last Update Posted:
2025-03-20
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of an Instrumented Ankle-foot Orthosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020427', 'term': 'Peroneal Neuropathies'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Trial with condition crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The instrumented orthosis prototype was never finished.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Temporal parameters', 'timeFrame': 'During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session', 'description': 'Gait Temporal parameters measured by the instrumented orthosis and the reference system, in seconds, these include the different phase durations(stride, stance and swing).'}, {'measure': 'Heel strike angle', 'timeFrame': 'During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session', 'description': 'Heel strike angle measured by the instrumented orthosis and the reference system'}, {'measure': 'Gait Spatial parameters', 'timeFrame': 'During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session', 'description': 'Gait Spatial parameters measured by the instrumented orthosis and the reference system, in meters, these include the length and width of the stride.'}, {'measure': 'Gait speed', 'timeFrame': 'During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session', 'description': 'Gait speed measured by the instrumented orthosis and the reference system, in meters per second.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankle foot orthosis', 'validation', 'survey', 'gait analysis', 'biomecanics'], 'conditions': ['Foot Drop']}, 'descriptionModule': {'briefSummary': "Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.\n\nTurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Patients questionnaire:\n\n* Having foot drop\n\nInclusion Criteria for Clinician questionnaire:\n\n* Being a clinician who treats foot drop patients\n\nInclusion Criteria for Gait analysis:\n\n* Having foot drop\n\nExclusion Criteria for Gait analysis:\n\n* Not being able to walk without a cane or a walker\n* Having lower extremity spasticity'}, 'identificationModule': {'nctId': 'NCT06115161', 'briefTitle': 'Development and Validation of an Instrumented Ankle-foot Orthosis', 'organization': {'class': 'OTHER', 'fullName': 'TOPMED'}, 'officialTitle': 'Development and Validation of an Instrumented Ankle-foot Orthosis', 'orgStudyIdInfo': {'id': '241_Tur_ApEval'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gait Analysis', 'description': 'Gait analysis with the instrumented orthosis as well as a reference sysmtem (Vicon Vantage 5).', 'interventionNames': ['Device: Instrumented Orthosis']}], 'interventions': [{'name': 'Instrumented Orthosis', 'type': 'DEVICE', 'description': 'Gait analysis will be performed with the instrumented orthosis as well as the reference system.', 'armGroupLabels': ['Gait Analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1S1C1', 'city': 'Québec', 'country': 'Canada', 'facility': 'TOPMED', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TOPMED', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natural Sciences and Engineering Research Council, Canada', 'class': 'OTHER'}, {'name': 'Turbomed Orthotics Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}