Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 1:22 PM
Study NCT ID:
NCT04909151
Status:
UNKNOWN
Last Update Posted:
2021-06-21
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072797', 'term': 'Walking Speed'}], 'ancestors': [{'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D016138', 'term': 'Walking'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait ability', 'timeFrame': 'Change from baseline gait ability at 6 weeks', 'description': 'Gait ability is evaluated using the Zebris FDM-Treadmill. When the participants walks on the treadmill, the foot pressure is recorded at a rate of 120 Hz. The input pressure signal is displayed as a 2D/3D graph including the center of pressure while standing or walking, and the spatiotemporal measurements are displayed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy', 'Gait Disorders, Neurologic', 'Bilateral Spastic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 4-12 years old diagnosed with cerebral palsy\n* Children who have not received botulinum toxin treatment or surgery within 3 months\n* Children in stage 2 of the gross motor function system\n* Children who can express pain, fear, or discomfort on their own\n\nExclusion Criteria:\n\n* Severe lower extremity contracture and fracture\n* Bone instability\n* Osteoporosis\n* Severe bones grow disproportionately\n* Unhealed skin lesions on the lower extremities (thromboembolic disease)\n* Thromboembolic disease\n* Cardiovascular instability\n* Mild scoliosis with a Cobb's angle of more than 20 degrees"}, 'identificationModule': {'nctId': 'NCT04909151', 'briefTitle': 'The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed', 'organization': {'class': 'OTHER', 'fullName': 'Sahmyook University'}, 'officialTitle': 'The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '2-1040781-A-N-012021050HR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-assisted gait training with walking speed of 0.5km/h', 'interventionNames': ['Device: Robot-assisted gait training (walking speed: 0.5km/h)']}, {'type': 'EXPERIMENTAL', 'label': 'Robot-assisted gait training with walking speed of 0.8km/h', 'interventionNames': ['Device: Robot-assisted gait training (walking speed: 0.8km/h)']}, {'type': 'EXPERIMENTAL', 'label': 'Robot-assisted gait training with walking speed of 1.1km/h', 'interventionNames': ['Device: Robot-assisted gait training (walking speed: 1.1km/h)']}], 'interventions': [{'name': 'Robot-assisted gait training (walking speed: 0.5km/h)', 'type': 'DEVICE', 'description': 'Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.', 'armGroupLabels': ['Robot-assisted gait training with walking speed of 0.5km/h']}, {'name': 'Robot-assisted gait training (walking speed: 0.8km/h)', 'type': 'DEVICE', 'description': 'Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.', 'armGroupLabels': ['Robot-assisted gait training with walking speed of 0.8km/h']}, {'name': 'Robot-assisted gait training (walking speed: 1.1km/h)', 'type': 'DEVICE', 'description': 'Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.', 'armGroupLabels': ['Robot-assisted gait training with walking speed of 1.1km/h']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10915', 'city': 'Paju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sun-Geon Park', 'role': 'CONTACT', 'email': 'spring1056@naver.com', 'phone': '+82-31-942-7500'}], 'facility': 'Pajucity convalescent Hospital', 'geoPoint': {'lat': 37.761, 'lon': 126.77272}}], 'centralContacts': [{'name': 'Sun-Geon Park, Ph.D candidate', 'role': 'CONTACT', 'email': 'spring1056@naver.com', 'phone': '+82-10-6204-8377'}], 'overallOfficials': [{'name': 'Sun-Geon Park, Ph.D candidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Wells Neuro Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'I plan to decide after the study is over.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahmyook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hyun-Joong Kim', 'investigatorAffiliation': 'Sahmyook University'}}}}