Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT05300867
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2022-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Rehabilitation Treatment of Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-03-19', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualiti of life measured by Barthel index', 'timeFrame': '3 weeks', 'description': 'quetionnaire'}, {'measure': 'gait/functional test', 'timeFrame': '3 weeks', 'description': '6 minute walk test (m)'}, {'measure': 'gait/functional test', 'timeFrame': '3 weeks', 'description': '10 m walk test (m/s)'}, {'measure': 'balance test', 'timeFrame': '3 weeks', 'description': 'Berg balance test'}, {'measure': 'postural control test', 'timeFrame': '3 weeks', 'description': 'posturography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balance', 'soft exoskeleton', 'walk', 'robotic'], 'conditions': ['Stroke, Acute', 'Stroke, Ischemic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/?term=robotic+rehabilitation%2C+soft+exoskeleton', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. In addition to the study of mtoros functions, the study of gait and codination is the primary result. Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously. Members of the control group receive standard rehabilitation therapy. After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6. Our main goal is to compare the results and determine the efficiency of the robotic device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npost stroke 6MWT : 120\\> minimum after stroke 3 days\n\nExclusion Criteria:\n\nSever heart problem sever demeanor alcoholism drug problems'}, 'identificationModule': {'nctId': 'NCT05300867', 'briefTitle': 'Robotic Rehabilitation Treatment of Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Somogy Megyei Kaposi Mór Teaching Hospital'}, 'officialTitle': 'Robotic Rehabilitation Treatment of Stroke Patients', 'orgStudyIdInfo': {'id': 'IKEB2021/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Robotic', 'interventionNames': ['Other: Neurorehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controll', 'interventionNames': ['Other: Physiotherapy']}], 'interventions': [{'name': 'Neurorehabilitation', 'type': 'OTHER', 'otherNames': ['Rob group'], 'description': 'Neurorehabilitation with soft exsoskeleton robotic 3-week-long', 'armGroupLabels': ['Robotic']}, {'name': 'Physiotherapy', 'type': 'OTHER', 'otherNames': ['Controll groum'], 'description': 'Physiotherapy 3-week-long', 'armGroupLabels': ['Controll']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Kaposvár', 'state': 'Somogy County', 'country': 'Hungary', 'facility': 'Dr. Tollár József', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Somogy Megyei Kaposi Mór Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. József Tollár, Head of Neurorehabilitation ,7400 Kaposvár, Tallián Gy. u 20-32', 'investigatorFullName': 'Tollár József', 'investigatorAffiliation': 'Somogy Megyei Kaposi Mór Teaching Hospital'}}}}