Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:20 PM
Study NCT ID:
NCT07492602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in gait speed', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Measuring changes in gait speed'}], 'secondaryOutcomes': [{'measure': 'Timed Up and Go', 'timeFrame': 'Baseline and 12-week Follow-Up', 'description': 'The Timed Up and Go test measures basic mobility and balance. Participants start seated in a chair, stand up, walk a short distance (3 meters), turn around, walk back to the chair, and sit down. The time it takes to complete the task is recorded in seconds. Shorter times indicate better mobility and functional walking ability.'}, {'measure': '10-Meter Walk Test', 'timeFrame': 'Baseline and 12-Week Follow-Up', 'description': 'The 10-Meter Walk Test measures walking speed over a short distance. Participants are asked to walk 10 meters at their normal walking pace. The time to walk the distance is recorded and used to calculate walking speed. Faster walking speeds indicate better walking ability.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['FES', 'Gait', 'Stroke', 'TBI', 'MS'], 'conditions': ['Stroke', 'Traumatic Brain Injury', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'People with neurological conditions often have difficulty walking, including problems such as foot drop. Functional electrical stimulation (FES) is a treatment that uses electrical signals to activate muscles and support walking. The L300 device is designed to help lift the foot during each step.\n\nThis study will evaluate how using the L300 affects walking performance. Researchers will measure walking speed, step length, and walking symmetry using objective gait assessment tools. The study will also explore whether people with different neurological conditions respond differently to FES.\n\nThe goal of this research is to improve understanding of how FES influences walking and to support more personalized rehabilitation approaches.', 'detailedDescription': 'Functional Electrical Stimulation (FES) is an established therapeutic approach that applies electrical currents to peripheral nerves to elicit muscle contractions, thereby facilitating movement in individuals with neurological impairments. FES has demonstrated benefits for improving motor function and gait in populations such as stroke survivors, individuals with spinal cord injury, and those with multiple sclerosis. By activating muscles during walking, FES can enhance gait parameters including speed, stride length, and symmetry, ultimately supporting greater independence and mobility.\n\nDespite these documented benefits, comparative data across neurological conditions remain limited, and the degree to which FES influences specific gait metrics is not fully understood. Furthermore, most prior studies have relied on basic clinical assessments, which may not capture the nuanced changes in gait mechanics that occur with FES intervention.\n\nThe L300 system is a widely used FES device designed to address foot drop by stimulating the peroneal nerve to facilitate ankle dorsiflexion during the swing phase of gait. This targeted approach can improve walking efficiency and reduce compensatory movements. However, the integration of advanced gait analysis technologies-such as wearable sensors and instrumented walkways-offers an opportunity to obtain objective, high-resolution data on spatiotemporal and kinematic parameters. These tools enable a more comprehensive evaluation of gait before and after FES intervention, providing insights into both functional outcomes and underlying biomechanical changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-80 years.\n* Diagnosis of stroke, traumatic brain injury, or multiple sclerosis confirmed by medical records.\n* Presence of foot drop or impaired ankle dorsiflexion during gait.\n* Ability to ambulate at least 10 meters with or without assistive devices.\n* Cognitive ability to follow simple instructions and provide informed consent.\n\nExclusion Criteria:\n\n* Severe lower limb contractures or orthopedic conditions that limit gait.\n* Implanted electrical devices (e.g., pacemaker) contraindicating FES use.\n* Uncontrolled medical conditions (e.g., severe cardiac disease).\n* Pregnancy.\n* Skin integrity issues preventing electrode placement.\n* Participation in other interventional gait studies within the past 3 months.'}, 'identificationModule': {'nctId': 'NCT07492602', 'briefTitle': 'Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Casa Colina Hospital and Centers for Healthcare'}, 'officialTitle': 'Comparison of Gait Metrics in Patients With Stroke, Traumatic Brain Injury, and Multiple Sclerosis Before and After Functional Electrical Stimulation', 'orgStudyIdInfo': {'id': 'GAIT2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Session Feasibility Study', 'description': 'Participants will undergo a single supervised session involving:\n\n1. Baseline gait assessment using the Baliston Health Gait System and the OneStep Gait Measurement Application.\n2. FES intervention with the L300 system (e.g., Bioness L300 Go), titrated to individual needs to facilitate ankle dorsiflexion.\n3. Immediate post-intervention gait assessment to evaluate changes in gait parameters with the L300.\n\nThis component will establish feasibility and inform protocol refinements for the randomized controlled trial.', 'interventionNames': ['Device: Functional Electrical Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Controlled Trial', 'description': 'A prospective, randomized, controlled trial will be conducted with N = 90 participants, stratified into three diagnostic groups (30 per group):\n\n* Group 1: Stroke\n* Group 2: Traumatic Brain Injury\n* Group 3: Multiple Sclerosis (or other specified neurological condition)\n\nProcedures:\n\n* Baseline Assessment: Comprehensive gait evaluation using Baliston Health and OneStep systems.\n* Intervention: Participants will receive FES via the L300 Go device during supervised sessions over 4 weeks. Stimulation parameters will be individualized and adjusted to optimize gait performance. Gait will be assessed each week for the 4 weeks.\n* Post-Intervention Assessment: Repeat gait evaluation immediately following the intervention period.\n* Follow-Up: A 12-week post-intervention assessment will be conducted to evaluate retention of gait improvements.', 'interventionNames': ['Device: Functional Electrical Stimulation']}], 'interventions': [{'name': 'Functional Electrical Stimulation', 'type': 'DEVICE', 'description': 'Functional Electrical Stimulation (FES) is an established therapeutic approach that applies electrical currents to peripheral nerves to elicit muscle contractions, thereby facilitating movement in individuals with neurological impairments. FES has demonstrated benefits for improving motor function and gait in populations such as stroke survivors, individuals with spinal cord injury, and those with multiple sclerosis. By activating muscles during walking, FES can enhance gait parameters including speed, stride length, and symmetry, ultimately supporting greater independence and mobility.', 'armGroupLabels': ['Randomized Controlled Trial', 'Single-Session Feasibility Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Casa Colina Hospital and Centers for Healthcare', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}], 'centralContacts': [{'name': 'Emily Rosario, PhD', 'role': 'CONTACT', 'email': 'erosario@casacolina.org', 'phone': '909-596-7733', 'phoneExt': '3036'}, {'name': 'Dan Humphrey, PT, DPT, NCS', 'role': 'CONTACT', 'email': 'dhumphrey@casacolina.org', 'phone': '909-596-7733', 'phoneExt': '3500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa Colina Hospital and Centers for Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director, Casa Colina Research Institute', 'investigatorFullName': 'Emily Rosario', 'investigatorAffiliation': 'Casa Colina Hospital and Centers for Healthcare'}}}}