Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07226518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Walking and tSCS in Non-ambulatory Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2025-11-04', 'studyFirstSubmitQcDate': '2025-11-07', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System)', 'timeFrame': 'Before and after 24 training sessions (8 weeks)', 'description': 'Cardiac output (L/min) will be measured using an impedance cardiography system (MP160, BIOPAC Systems Inc., Goleta, California). Measurements will be done during a 6-minute walk test. Data collection for each participant will occur at approximately the same time of day (between 9:00 AM and 11:00 AM) before the first intervention session and after completion of the 24th intervention session.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['stroke gait rehabilitation', 'Transcutaneous spinal cord stimulation', 'Non invasive spinal cord stimulation', 'Robot assisted gait training'], 'conditions': ['Chronic Stroke Survivors', 'Chronic Stroke Patients', 'Stroke']}, 'descriptionModule': {'briefSummary': 'Rehabilitation interventions commonly used for stroke survivors include task-specific training, balance and strength exercises, and the use of assistive devices to enhance mobility and independence. Advanced technologies, such as body-weight-supported treadmill systems and robotic devices, may be employed when appropriate. Current rehabilitation therapies for stroke survivors are moderately effective with a limited effect size, especially in stroke survivors with severe impairment. Novel therapies, such as transcutaneous spinal cord stimulation (tSCS), may further improve outcomes in the target population. This pilot study will allow us to examine the feasibility and gather pilot data on a combined intervention of assistive gait training and tSCS in non-ambulatory stroke survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-80 years at time of consent\n2. All genders included.\n3. Chronic ischemic or hemorrhagic stroke \\>=6 months, with limited within-home comfortable walking speed \\<= 0.49 m/s and unable to walk independently in community (FAC \\<= 3)\n4. Able to communicate with investigators, follow 2-step command, and correctly answer consent comprehension questions in English.\n5. Currently not participating in treadmill walking exercises or exercises involving weight-bearing activities.\n6. Have physicians' approval for exercise and be in a stable medical condition\n\nExclusion Criteria:\n\n1. Hospitalization for cardiac or pulmonary disease within the past 3 months\n2. Have musculoskeletal disorders that prevent the participant from participating in the exercise\n3. Blood pressure higher than 200/110 mm Hg\n4. Significant ataxia or unilateral spatial neglect (score of 2 on NIH stroke scale item 7 or 11)\n5. Reported pain that limits or interferes with activities of daily living and physical activity/exercise\n6. Diagnosis of other neurological diseases (multiple sclerosis, Alzheimer's disease, Parkinson's disease)\n7. Diagnosis of severe depression (HADS score 15-21)\n8. Unable to speak or understand English, and travel to the research laboratory.\n9. Contraindications to tSCS and TMS"}, 'identificationModule': {'nctId': 'NCT07226518', 'briefTitle': 'Walking and tSCS in Non-ambulatory Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Robot-assisted Gait Training and Transcutaneous Spinal Cord Stimulation in Chronic Non-ambulatory Stroke Survivors: Pilot RCT Trial', 'orgStudyIdInfo': {'id': 'STUDY00162114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot assisted gait training combined with Transcutaneous spinal cord stimulation', 'interventionNames': ['Device: Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Robot assisted gait training alone', 'interventionNames': ['Device: Robot assisted gait training alone']}], 'interventions': [{'name': 'Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial', 'type': 'DEVICE', 'description': 'Participants in the experimental group will receive 30 minutes of robot assisted gait training (RAGT) transcutaneous spinal cord stimulation 3 times per week, 8 weeks, totaling 24 sessions. The gait training will utilize a treadmill equipped with a partial-body-weight support system and a lab-developed RAGT device. The RAGT protocol will be the same as in the control group', 'armGroupLabels': ['Robot assisted gait training combined with Transcutaneous spinal cord stimulation']}, {'name': 'Robot assisted gait training alone', 'type': 'DEVICE', 'description': 'Participants in the control group will receive 30 minutes of assisted gait training (RAGT), 3 times per week, for 8 weeks, totaling 24 sessions. The gait training will utilize a treadmill equipped with a partial-body-weight support system and a lab-developed RAGT device', 'armGroupLabels': ['Robot assisted gait training alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Mustapha Mangdow, PT, MS', 'role': 'CONTACT', 'email': 'mmangdow@kumc.edu', 'phone': '9132421754'}, {'name': 'Wen Liu, PhD', 'role': 'CONTACT', 'email': 'wliu@kumc.edu'}], 'facility': 'Neuromuscular Research Laboratory', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Mustapha Mangdow, PT. MS', 'role': 'CONTACT', 'email': 'mmangdow@kumc.edu', 'phone': '913-2421754'}], 'overallOfficials': [{'name': 'Wen Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen Liu, Ph.D.', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}