Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-05 @ 1:10 PM
Study NCT ID:
NCT07411703
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swing phase asymmetry', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).', 'description': 'Swing-phase asymmetry, defined as the difference in swing-phase proportion between the non-paretic and paretic limbs- will be calculated from toe-off to heel-strike timing within the gait cycle, using the wearable inertial measurement units (IMUs) before and after the NDT gait training intervention .'}, {'measure': 'Pelvic rotation amplitude', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).', 'description': 'Gait data will be acquired via wearable IMUs before and after the NDT gait training intervention, and the amplitude of pelvic rotation will be derived from axial angular velocity data.'}, {'measure': 'Walking speed', 'timeFrame': 'Baseline (pre-intervention) and post-intervention (immediately after completion of the NDT gait training program).', 'description': 'Walking speed will be quantified during gait using IMU-based measurements, and the average walking speed for each stage will be computed from recorded motor-driven motion data and reported in meters per second (m/s).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of an automated mobile gait training device developed based on neurodevelopmental treatment (NDT) principles for patients with hemiplegic stroke. Stroke is a major cause of long-term disability, and many survivors experience impaired walking ability that affects their independence and daily functioning. NDT is a commonly used rehabilitation approach that emphasizes therapist-guided facilitation of normal movement patterns during gait training. However, conventional NDT gait training is physically demanding and time-consuming for therapists, which may limit the amount of repetitive gait practice patients can receive.\n\nTo address these limitations, this study introduces a power-assisted gait training device capable of reproducing key therapeutic interventions typically provided by therapists. The system uses synchronized dynamic assistance, auditory cues, and wearable inertial measurement units (IMUs) to support gait training on the ground and facilitate more natural and repetitive walking practice. The IMUs provide objective gait data that are used to evaluate changes in swing-phase symmetry, pelvic rotation amplitude, and walking speed.\n\nThe primary goal of this study is to assess changes in these gait parameters following training with the proposed NDT-based assistive device. The study plans to enroll 60 adult stroke survivors (aged 20 and older) over a 3-year period starting from March 26, 2025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult stroke survivors with hemiplegia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years, first-ever stroke, with Brunnstrom stage III to IV of the affected lower limb motor recovery.\n* Functional Ambulation Category (FAC) level IV.\n* Ability to ambulate on level ground without assistive devices.\n* Ability to understand instructions and cooperate with assessments.\n\nExclusion Criteria:\n\n* Presence of severe spinal cord injury or peripheral neuropathy.\n* Unstable gait requiring assistive devices, or participants at high risk of falling.\n* Severe impairment in vision, hearing, or cognition, making them unable to comply with assessments.\n* Lower limb fracture within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT07411703', 'briefTitle': 'Automated Trainer-Based Gait Rehabilitation for Hemiplegic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cheng-Hsin General Hospital'}, 'officialTitle': 'Gait Training for Hemiplegic Stroke Patients: Employing an Automated Trainer With Sensory Cues', 'orgStudyIdInfo': {'id': 'CHGH-(1140)113-70'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NDT Gait Training System', 'type': 'DEVICE', 'description': 'The intervention consists of an NDT gait training device that replicates therapist-applied techniques through mechanical assistance, combined with synchronized auditory feedback and real-time gait analysis using IMU sensors.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '112050', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Cheng Hsin General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Szu-Fu Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD, PhD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cheng-Hsin General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}