Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-29 @ 7:07 PM
Study NCT ID:
NCT03979235
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor function assessment', 'timeFrame': 'Change from Baseline scores at 1 month', 'description': 'Fugl-Meyer Assessment'}], 'secondaryOutcomes': [{'measure': 'surface EMG', 'timeFrame': 'Change from Baseline status at 1 month', 'description': 'high-density surface EMG'}, {'measure': 'Kinematics test', 'timeFrame': 'Change from Baseline status at 1 month', 'description': 'Using inertia sensors to assess kinematics during movement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Motor Deficits', 'Dysphagia']}, 'descriptionModule': {'briefSummary': 'Using robotics, sensors, and sEMG to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation', 'detailedDescription': 'Using robotics, sensors, sEMG or other methods to develop clinic-oriented quantitative effectiveness evaluation and individualized programs of rehabilitation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruiting with advertising', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (for healthy people):\n\n* no history of psychological/psychotic problems, no history of important diseases.\n\nExclusion Criteria (for healthy people):\n\n* history of psychological/psychotic problems\n\nInclusion Criteria (for patients with motor deficits or dysphagia):\n\n* patients with motor function impairment such as post stroke hemiplegia.\n\nExclusion Criteria (for patients with motor deficits or dysphagia):\n\n* cognitively or physically unable to cooperate with the examiner to finish the test'}, 'identificationModule': {'nctId': 'NCT03979235', 'briefTitle': 'Developing Effectiveness Evaluation and Therapeutic Programs of Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'National Research Center for Rehabilitation Technical Aids'}, 'officialTitle': 'Developing Clinic-oriented Quantitative Effectiveness Evaluation and Individualized Therapeutic Programs of Rehabilitation', 'orgStudyIdInfo': {'id': '20180104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heahlthy people', 'description': 'perform motor function assessment by using scales, sEMG, and inertia sensors', 'interventionNames': ['Diagnostic Test: Motor function assessment']}, {'label': 'People with motor deficits', 'description': 'perform motor function assessment by using scales, sEMG, and inertia sensors', 'interventionNames': ['Diagnostic Test: Motor function assessment']}, {'label': 'Patients with dysphagia', 'description': 'perform motor function assessment by using scales, sEMG, and inertia sensors', 'interventionNames': ['Diagnostic Test: Motor function assessment']}], 'interventions': [{'name': 'Motor function assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'perform motor function assessment by using scales, sEMG, and inertia sensors', 'armGroupLabels': ['Heahlthy people', 'Patients with dysphagia', 'People with motor deficits']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100176', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'PX Wei, Dr.', 'role': 'CONTACT', 'email': 'pengxuwei@gmail.com', 'phone': '86-10-58122921'}], 'facility': 'National Research Center for Rehabilitation Technical Aids', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'LT Wang, PhD', 'role': 'CONTACT', 'email': 'suhonglun@nrcrta.cn', 'phone': '86-10-58122882'}, {'name': 'PX Wei, PhD', 'role': 'CONTACT', 'email': 'pengxuwei@gmail.com', 'phone': '86-10-58122921'}], 'overallOfficials': [{'name': 'PX Wei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Center for Rehabilitation Technical Aids'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Rehabilitation Technical Aids', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Pengxu Wei', 'investigatorAffiliation': 'National Research Center for Rehabilitation Technical Aids'}}}}