Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-03 @ 8:52 AM
Study NCT ID:
NCT01825135
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2013-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-04-02', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Functional Independence Measurement (FIM) score', 'timeFrame': 'Hospital discharge, an expected average stay of 5 weeks', 'description': 'Functional status as measured by modified Functional Independence Measurement (FIM) score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['muscle strength', 'muscle function', 'functional status'], 'conditions': ['Muscle Weakness']}, 'descriptionModule': {'briefSummary': 'The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* duration of mechanical ventilation for 14 days or more\n* sufficiently awake\n* able to speak and comprehend English\n\nExclusion Criteria:\n\n* known primary neuromuscular disease\n* lower extremities paresis or amputee\n* patients with left-ventricular assist device (LVAD)\n* cardiopulmonary instability'}, 'identificationModule': {'nctId': 'NCT01825135', 'briefTitle': 'Electrical Stimulation to Strengthen Muscles in the Lower Legs in Patients Requiring Prolonged Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'RML Specialty Hospital'}, 'officialTitle': 'Electrical Stimulation to Strengthen the Quadriceps Muscles in Patients Requiring Prolonged Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'AXJ012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuromuscular electrical stimulation', 'description': 'Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes', 'interventionNames': ['Device: Neuromuscular electrical stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham stimulation', 'description': 'Sham stimulation will be applied to the quadriceps for 30 minutes', 'interventionNames': ['Device: sham stimulation']}], 'interventions': [{'name': 'Neuromuscular electrical stimulation', 'type': 'DEVICE', 'otherNames': ['300PV™ neuromuscular stimulation (NMES)device'], 'armGroupLabels': ['Neuromuscular electrical stimulation']}, {'name': 'sham stimulation', 'type': 'DEVICE', 'otherNames': ['300PV™ Neuromuscular Stimulation (NMES) device'], 'description': 'sham stimulation will be applied to the quadriceps', 'armGroupLabels': ['Sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'RML Specialty Hospital', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}], 'overallOfficials': [{'name': 'Amal Jubran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RML Specialty Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RML Specialty Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator-Staff Physician', 'investigatorFullName': 'Amal Jubran', 'investigatorAffiliation': 'RML Specialty Hospital'}}}}