Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-25 @ 3:03 PM
Study NCT ID:
NCT06153992
Status:
UNKNOWN
Last Update Posted:
2023-12-01
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D064424', 'term': 'Tobacco Use'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-21', 'size': 172907, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-29T20:38', 'hasProtocol': True}, {'date': '2023-11-21', 'size': 135112, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-29T20:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2023-11-29', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body function', 'timeFrame': 'up to 1 month', 'description': 'Evaluate lower limb motor function using the Fugl Meyer method (total lower limb motor score 0-34 points, total balance score 0-14 points).'}, {'measure': 'Measured peak moment', 'timeFrame': 'up to 1 month', 'description': 'Peak moment of knee joint at 60 °/s angular velocity in Nm'}], 'secondaryOutcomes': [{'measure': 'Satisfaction questionnaire survey', 'timeFrame': 'up to 1 month', 'description': "Survey of patients' comfort and satisfaction with the treatment process and effectiveness(score 0-100 points)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Hemiplegia', 'Rehabilitation; Tobacco Use', 'Physical Disability']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare in describeparticipant population. The main question it aims to answer is:By using intelligent portable isokinetic tester and traditional isokinetic tester, isokinetic knee flexor and extensor muscles of stroke patients with hemiplegia were trained respectively, so as to observe and compare the effects of the two treatment methods. In addition, the therapeutic effect of the above two treatments was compared with that of exercise therapy alone. Participants will be divided into three groups: control group, intelligent isokinetic treatment group, and traditional isokinetic treatment group. Participants of both the control group and the two treatment groups received exercise therapy. On the basis of exercise therapy, participants of the intelligent isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle, while the participants of traditional isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Cerebral apoplexy's Disease\n* Confirmed by CT or MR Examination of the head\n* First onset, duration ≤1 month\n* The lower extremity of the hemiplegic limb was above Brunnstrom stage III\n* Must be able to sign the informed consent form\n\nExclusion Criteria:\n\n* Vital signs are unstable\n* Severe cognitive, visual and hearing impairment\n* Orthopaedic disease\n* Muscle pain lower extremity\n* Congenital disease\n* History of other encephalopathy\n* History of mental illness"}, 'identificationModule': {'nctId': 'NCT06153992', 'briefTitle': 'Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology', 'orgStudyIdInfo': {'id': '2021004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group received exercise therapy (once a day, 40min/ times, 5 times/week), occupational therapy (once a day, 30min/ times, 5 times/week), low-frequency electricity (once a day, 20min/ times, 5 times/week), acupuncture therapy (once a day, 20min/ times, 5 times/week) .', 'interventionNames': ['Other: without test training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional isokinetic treatment group', 'description': 'The treatment machine adopts the traditional isokinetic training machine, the treatment items and the treatment parameters are the same as the intelligent isokinetic treatment group.', 'interventionNames': ['Device: isokinetic muscle strength test training', 'Other: without test training']}, {'type': 'EXPERIMENTAL', 'label': 'Intelligent isokinetic treatment group', 'description': "In the intelligent isokinetic treatment group, isokinetic muscle strength training of hemiplegic lower limb flexion muscle group and knee extension muscle group was added to the treatment of the control group.\n\nIntelligent isokinetic treatment to increase the above treatment hemiplegic lower limb flexion, knee extension muscle isokinetic strength training. The patient's seat back was adjusted to 85° and fixed with a belt and shoulder cross-strap. The thigh of the subject was fixed with a nylon buckle, the lateral condyle of the femur was the axis, the lever arm length was scale 12, and the distal leg was fixed above the ankle. Passive joint activities were performed on the knee and ankle before training. Avoid joint damage and perform three low-resistance warm-up exercises. Choose 60°/s, 90°/s, 120°/s angular speed isokinetic training according to the patient's specific conditions. Each angular speed training is 10 times, the interval rest is 15s.ect.", 'interventionNames': ['Device: Intelligent portable isokinetic muscle strength test training', 'Other: without test training']}], 'interventions': [{'name': 'Intelligent portable isokinetic muscle strength test training', 'type': 'DEVICE', 'description': 'The isokinetic training of knee flexors and extensors was carried out by using intelligent portable isokinetic muscle strength test training system', 'armGroupLabels': ['Intelligent isokinetic treatment group']}, {'name': 'isokinetic muscle strength test training', 'type': 'DEVICE', 'description': 'The isokinetic training of knee flexors and extensors was carried out by using isokinetic muscle strength test training system', 'armGroupLabels': ['Traditional isokinetic treatment group']}, {'name': 'without test training', 'type': 'OTHER', 'description': 'Treatment was performed without using any isokinetic muscle strength test training system', 'armGroupLabels': ['Control group', 'Intelligent isokinetic treatment group', 'Traditional isokinetic treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'docter', 'role': 'CONTACT', 'email': '17686689905@126.com', 'phone': '15866616997'}], 'facility': 'Intelligent Multi Joint Isokinetic', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Ran Shi, doctor', 'role': 'CONTACT', 'email': 'zm17686689905@126.com', 'phone': '17686689905'}, {'name': 'May Zheng, doctor', 'role': 'CONTACT', 'email': 'zm17686689905@126.com', 'phone': '13658602285'}], 'overallOfficials': [{'name': 'Sanyuan Hu, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Qianfoshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ran Shi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ran Shi', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}