Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-03 @ 5:13 AM
Study NCT ID:
NCT06516458
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinematics of the gait cycle', 'timeFrame': 'at the time of session', 'description': 'Joint position of lower limbs during a single cycle of gait'}], 'secondaryOutcomes': [{'measure': '6 minute walk test', 'timeFrame': 'at the time of session', 'description': 'you will be instructed to walk as quickly and safely as you can while being timed for 6 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Multiple Sclerosis, Secondary Progressive', 'Multiple Sclerosis Relapse', 'Multiple Sclerosis, Relapsing-Remitting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).', 'detailedDescription': "In rehabilitation in general, in order to track patients' progress and provide next steps, there is a need for easily obtainable, understandable, and objective measures of ability. Currently, there is no measure that clinicians can utilize to determine walking quality. While Gait Deviation Index has been validated and can reliably be used in adults who experienced a Spinal Cord Injury, it has not yet been validated in people with MS. After the MS-specific GDI is developed from this study, therapists and clinicians will be able use it as a reliable progress measure. Which may lead to the delivery of more effective therapy for patients with MS.\n\nHere we plan to measure body position with camera based tracking during your gait cycle."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons with multiple sclerosis who can ambulate overground', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of relapsing form of MS (including relapsing-remitting MS and secondary progressive MS)\n* Able to ambulate overground\n* Relapse free for at least 1 month\n* Age ≥18 and ≤ 75 years\n* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening\n\nExclusion criteria:\n\n\\- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing'}, 'identificationModule': {'nctId': 'NCT06516458', 'acronym': 'MS-GDI', 'briefTitle': 'Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Development of Camera Based Gait Deviation Index for Persons With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'STU00221990'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'Gait quality observation', 'interventionNames': ['Diagnostic Test: Camera Based Kinematic Analysis']}], 'interventions': [{'name': 'Camera Based Kinematic Analysis', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['OpenCap'], 'description': 'Observational Study using Camera Based, Marker Less Kinematic Analysis of gait quality of persons with Multiple Sclerosis', 'armGroupLabels': ['Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Weena Dee, DPT', 'role': 'CONTACT', 'email': 'wdee@sralab.org', 'phone': '312-238-7503'}, {'name': 'Alex Barry, MS,CCRC', 'role': 'CONTACT', 'email': 'abarry@sralab.org', 'phone': '312-238-1435'}], 'facility': 'Shirley Ryan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Weena Dee', 'role': 'CONTACT', 'email': 'wdee@sralab.org', 'phone': '312-328-7503'}, {'name': 'Alex Barry', 'role': 'CONTACT', 'email': 'abarry@sralab.org', 'phone': '312-238-1435'}], 'overallOfficials': [{'name': 'Milap Sandhu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Share overall data set'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Milap Sandhu', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}