Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-29 @ 2:17 AM
Study NCT ID:
NCT05518058
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2022-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromyography Triggered Functional Electrical Stimulation on Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural stability', 'timeFrame': '2 months', 'description': 'biodex balance system'}], 'secondaryOutcomes': [{'measure': 'dynamic balance', 'timeFrame': '2 months', 'description': 'timed up and go test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'my study aims to apply treatment program for postural instability in stroke patients.', 'detailedDescription': 'my study include two groups: first group receive physical therapy exercise program followed by balance exercise program.\n\nthe second group receive the same physical therapy exercise program followed by balance exercise program conducted with electromyography triggered functional electrical stimulation'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke patients\n* normal body mass index\n* mild spasticity\n\nExclusion Criteria:\n\n* musculoskeletal deformities\n* cognitive abnormalities\n* cardiovascular diseases'}, 'identificationModule': {'nctId': 'NCT05518058', 'briefTitle': 'Electromyography Triggered Functional Electrical Stimulation on Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Effect of Electromyography Triggered Functional Electrical Stimulation on Stroke Patients', 'orgStudyIdInfo': {'id': 'Delta 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'strengthening exercises program plus balance exercises program', 'interventionNames': ['Other: device and exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'strengthening exercises program plus balance exercises program conducted with EMG triggered FES', 'interventionNames': ['Other: device and exercises']}], 'interventions': [{'name': 'device and exercises', 'type': 'OTHER', 'otherNames': ['therapeutic exercises program / EMG triggered FES device'], 'description': 'strengthening exercises plus balance training program conducted with type of functional electrical stimulation for muscles', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Damietta', 'state': 'Texas', 'country': 'Egypt', 'facility': 'Hend Elsharkawy', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'after 12 months from publication', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Hend Elsharkawy', 'investigatorAffiliation': 'Delta University for Science and Technology'}}}}