Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06928194
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Kinovea in Gait Assessment in Multiple Sclerosis: a Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step length (cm)', 'timeFrame': 'With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.', 'description': 'Distance between the two heel strike points during initial contact of opposing feet.'}, {'measure': 'Stride length (cm)', 'timeFrame': 'With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.', 'description': 'Distance between the two heel strike points during initial contact of the same foot. Two step lengths add up to one stride length.'}, {'measure': 'Support base (cm)', 'timeFrame': 'With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.', 'description': 'Distance between the midpoints of the heels of two consecutive steps'}, {'measure': 'Cadence (steps/min)', 'timeFrame': 'With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.', 'description': 'Number of steps taken during a given period'}, {'measure': 'Walking speed (cm/s)', 'timeFrame': 'With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.', 'description': 'Time taken to walk a known distance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Gait Disorders, Neurologic', 'Kinovea', 'GAITRite'], 'conditions': ['Multiple Sclerosis', 'Gait Disorders, Neurologic']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study is to determine whether the Kinovea video analysis tool is valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis, comparing the data obtained from this system with those of the gold standard, the GaitRite system. The main question to be answered is:\n\nIs the Kinovea system valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis?\n\nParticipants walked across the GAITRite platform four times without shoes and four times with shoes, while being recorded by two cameras simultaneously: one recorded gait from the sagittal plane and the other from the frontal plane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young-to-middle-aged people with multiple sclerosis who maintain the ability to walk and who come to the laboratory for their scheduled checkups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for evaluation by the NeuroLab-Lázaro gait laboratory (Seville).\n* Patients who have signed informed consent prior to the test.\n* Patients between 18 and 55 years of age, diagnosed with MS according to the 2017 McDonald criteria.\n* Patients with an EDSS score of less than 6.5 points.\n* Patients who are willing to participate in the study and who do not object to being recorded while performing the gait test and to the use of images for educational and research purposes.\n\nExclusion Criteria:\n\n* Patients who use walking aids and/or orthoses.\n* Patients with comorbidity or decompensated systemic disease within the last month.\n* Patients who have any physical impediment (excessive fatigue) to performing the gait test, as documented in their medical records reviewed on the Diraya platform.\n* Patients who have suffered a relapse within 30 days prior to the start of the study.'}, 'identificationModule': {'nctId': 'NCT06928194', 'acronym': 'KV-MS', 'briefTitle': 'Reliability of Kinovea in Gait Assessment in Multiple Sclerosis: a Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'University of Cadiz'}, 'officialTitle': 'Reliability of the Kinovea System in the Study of Spatiotemporal Gait Parameters in Multiple Sclerosis: a Pilot Study.', 'orgStudyIdInfo': {'id': 'SICEIA-2025-000557'}}, 'contactsLocationsModule': {'locations': [{'zip': '41015', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'NeuroLab-Lázaro', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Carlos Luque Moreno', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Seville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cadiz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Physiotherapist, student of a master's degree in Neurological Physiotherapy", 'investigatorFullName': 'Antonio Gil Centeno', 'investigatorAffiliation': 'University of Cadiz'}}}}