Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT05574556
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electromiographic Analysis of the Quadriceps After Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2022-10-05', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'electromyography', 'timeFrame': 'one time - during the procedure', 'description': 'will be performed an examination of electrical muscle conductance'}], 'secondaryOutcomes': [{'measure': 'myoelectric activity of the quadriceps muscle', 'timeFrame': 'one time - during the procedure', 'description': 'will be performed an examination of electrical muscle conductance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leg Injury', 'Bone Fracture']}, 'descriptionModule': {'briefSummary': "The lower limb is the region most affected by fractures in the human body. The magnitude of the trauma can cause injuries to structures adjacent to the fracture, promoting joint instability and consequently predisposition to osteoarthritis. The treatment of fractures can be performed conservatively or surgically, and one of the consequences of the surgery is arthrogenic muscle inhibition, which presents itself as a marked muscle weakness due to inhibition of the central nervous system that prevents adequate muscle activation. However, recruiting the quadriceps is the most commonly used goal to determine the patient's return to activities. Physiotherapy has several resources for the functional activation of the quadriceps muscle, such as neuromuscular electrostimulation (NMES), verbal command of muscle activation and neuromatrix techniques. Thus, the objective of this study will be to analyze, by means of electromyography, the myoelectric activity of the quadriceps muscle in individuals undergoing physical therapy intervention, affected by some fracture of the lower limb."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ANALYSIS OF THE QUADRICEPS AFTER TRAUMA IN LOWER MEMBERSINTERVENTION', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trauma in lower member intervention\n\nExclusion Criteria:\n\n* neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT05574556', 'briefTitle': 'Electromiographic Analysis of the Quadriceps After Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Electromiographic Analysis of the Quadriceps in Individuals Undergoing Neuromuscular Electro-stimulation Intervention, Verbal Command and Neuromatrix', 'orgStudyIdInfo': {'id': 'Electromiographic Analysis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'myoelectric activity of the quadriceps muscle', 'description': 'electromyography myoelectric activity of the quadriceps muscle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03156001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Claudio Cazarini Júnior', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}