Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT07087769
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will undergo multiple gait training conditions in a single session, including combinations of treadmill walking (tied-belt and split-belt), backward resistance (pelvis, ankle, or both), and sensory feedback (visual, auditory, or combined). All participants will receive all conditions in a within-subject crossover design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Paretic Leg Propulsive Force', 'timeFrame': 'Within a single session (approximately 2 hours)', 'description': 'Peak anterior ground reaction force of the paretic leg will be measured using an instrumented split-belt treadmill . Changes in propulsive force under different treadmill and resistance/feedback conditions will be analyzed to evaluate improvements in gait symmetry.'}], 'secondaryOutcomes': [{'measure': 'Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking', 'timeFrame': 'Day 1 (during treadmill and overground walking trials)', 'description': 'Surface EMG (Delsys Inc.) will be used to measure activity of major lower limb muscles (e.g., Tibialis anterior and soleus) during treadmill walking under different resistance and feedback conditions.'}, {'measure': 'Step Length (m) During Overground Walking Using Zeno Walkway', 'timeFrame': 'Day 1 (during overground walking trials)', 'description': 'Step length (in meters) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average step length for each participant will be reported.'}, {'measure': 'Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System', 'timeFrame': 'Day 1 (during treadmill walking trials)', 'description': 'Hip joint range of motion (ROM), measured in degrees, will be assessed using the Vicon motion capture system during treadmill walking on Day 1. ROM will be defined as the difference between peak flexion and peak extension angles in the sagittal plane. Kinematic data will be collected across multiple gait cycles, and the average ROM per participant will be reported.'}, {'measure': 'Walking Speed (m/s) During Overground Walking Using Zeno Walkway', 'timeFrame': 'Day 1 (during overground walking trials)', 'description': 'Walking speed (in meters per second) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average walking speed for each participant will be reported.'}, {'measure': 'Cadence (steps/min) During Overground Walking Using Zeno Walkway', 'timeFrame': 'Day 1 (during overground walking trials)', 'description': 'Cadence (in steps per minute) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average cadence will be reported per participant.'}, {'measure': 'Swing Time (s) During Overground Walking Using Zeno Walkway', 'timeFrame': 'Day 1 (during overground walking trials)', 'description': 'Swing time (in seconds) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average swing time per leg will be reported per participant.'}, {'measure': 'Stance Time (s) During Overground Walking Using Zeno Walkway', 'timeFrame': 'Day 1 (during overground walking trials)', 'description': 'Stance time (in seconds) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average stance time per leg will be reported per participant.'}, {'measure': 'Stride Length (m) During Overground Walking Using Zeno Walkway', 'timeFrame': 'Day 1 (during overground walking trials)', 'description': 'Stride length (in meters) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average stride length per participant will be reported.'}, {'measure': 'Knee Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System', 'timeFrame': 'Day 1 (during treadmill walking trials)', 'description': 'Knee joint range of motion (ROM), measured in degrees, will be assessed using the Vicon motion capture system during treadmill walking on Day 1. ROM will be defined as the difference between peak flexion and peak extension angles in the sagittal plane. Multiple gait cycles will be analyzed, and the average ROM per participant will be reported.'}, {'measure': 'Ankle Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System', 'timeFrame': 'Day 1 (during treadmill walking trials)', 'description': 'Ankle joint range of motion (ROM), measured in degrees, will be assessed using the Vicon motion capture system during treadmill walking on Day 1. ROM will be calculated as the difference between peak dorsiflexion and peak plantarflexion angles in the sagittal plane. Data from multiple gait cycles will be averaged and reported per participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Split-belt Treadmill', 'Resistance Exercise', 'Feedback', 'Gait Training']}, 'descriptionModule': {'briefSummary': 'This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.', 'detailedDescription': "The purpose of this study is to assess the effectiveness of an integrated gait training paradigm that combines mechanical task constraints and sensory feedback during split-belt treadmill walking to enhance paretic leg propulsion and improve propulsion symmetry in individuals post-stroke. The risks associated with this study are lower than those encountered during daily walking in the community and in typical physical therapy clinics, where patients with physical impairments routinely engage in challenging exercises to improve their abilities. There is a slight possibility of local skin irritation or rash resulting from the non-allergenic adhesive tape or sensor gel used to attach the EMG sensors. This is a rare occurrence and typically resolves within one to two days without medical intervention.\n\nThis study will last approximately one to two hours, depending on your condition, and involves a one-time visit.\n\nIf you choose to participate in this study, the participant will be asked to:\n\n1. Sign a consent form approved by the University of Texas Medical Branch IRB, outlining the study's purpose, procedures, benefits, risks, and policies.\n2. Share medical history and well-being, and have weight, height, and heart rate (via smartwatch) monitored.\n3. Assess your walking capacity.\n4. Assess the Optimal Gait Training Protocol using Treadmill, Sensory Feedback, and Mechanical task constraints."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged 20 years or older\n\nFor stroke group: clinical diagnosis of stroke at least 1 month prior to participation\n\nAbility to walk at least 10 meters with or without assistive devices\n\nFor healthy group: able to walk independently without assistive devices\n\nExclusion Criteria:\n\nLife expectancy less than one year\n\nComatose or unable to follow three-step commands\n\nAmputation of any lower limb\n\nPoorly controlled diabetes (e.g., foot ulceration)\n\nBlindness\n\nProgressive neurological disease\n\nMedically unstable condition\n\nSignificant musculoskeletal impairments affecting gait\n\nCongestive heart failure or unstable angina\n\nPeripheral vascular disease\n\nSevere neuropsychiatric conditions (e.g., dementia, cognitive deficits, severe depression)'}, 'identificationModule': {'nctId': 'NCT07087769', 'briefTitle': 'Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Optimizing Post-Stroke Gait Symmetry: Integrating Mechanical Constraints and Sensory Feedback to Enhance Paretic Leg Propulsion', 'orgStudyIdInfo': {'id': '25-0102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gait Training with Combined Sensory Feedback and Mechanical Constraints', 'description': 'All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.', 'interventionNames': ['Behavioral: Treadmill Walking with Split-Belt and/or Tied-Belt Conditions', "Behavioral: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity", 'Behavioral: Sensory Feedback Training']}], 'interventions': [{'name': 'Treadmill Walking with Split-Belt and/or Tied-Belt Conditions', 'type': 'BEHAVIORAL', 'description': 'Participants will walk on an instrumented treadmill under split-belt and/or tied-belt conditions depending on their walking capacity. The belt speeds will be adjusted to facilitate locomotor adaptation and evaluate propulsion symmetry.', 'armGroupLabels': ['Gait Training with Combined Sensory Feedback and Mechanical Constraints']}, {'name': "Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity", 'type': 'BEHAVIORAL', 'description': 'Participants will walk on a treadmill (Split-belt and/or Tied-belt) with backward-directed resistance applied at the pelvis, ankle, or both. The resistance is used to challenge paretic leg propulsion and assess adaptive gait responses.', 'armGroupLabels': ['Gait Training with Combined Sensory Feedback and Mechanical Constraints']}, {'name': 'Sensory Feedback Training', 'type': 'BEHAVIORAL', 'description': 'Real-time feedback-visual, auditory, or combined-will be provided based on the propulsive force generated during split-belt and/or tied-belt treadmill walking, with or without mechanical resistance.', 'armGroupLabels': ['Gait Training with Combined Sensory Feedback and Mechanical Constraints']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mansoo Ko', 'role': 'CONTACT', 'email': 'mako@utmb.edu', 'phone': '409-772-9555'}], 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Mansoo Ko, PhD', 'role': 'CONTACT', 'email': 'mako@utmb.edu', 'phone': '409-747-1617'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}