Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-30 @ 11:33 PM
Study NCT ID:
NCT06099132
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antagonist Activation Measurement at the Ankle Using High-density and Bipolar Surface EMG in Chronic Hemiparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], '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': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coefficient of ANtagonist activation', 'timeFrame': '5 seconds', 'description': 'The Coefficient of ANtagonist activation of 3 muscles was calculated by the ratio between the root mean square amplitude during antagonist effort and maximal agonist effort for the same muscle.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Muscle Hypertonia', 'Spasticity, Muscle']}, 'descriptionModule': {'briefSummary': 'In chronic hemiparesis, abnormal antagonist muscle activation in the paretic lower limb contributes to impair ambulation capacities. A biased estimate of antagonist muscle activation when using surface bipolar EMG compared with high-density (HD) EMG has been previously reported in healthy subjects. The present study compares muscles cocontraction at the paretic ankle estimated with a pair of and multi-channel surface EMG.', 'detailedDescription': 'In chronic hemiparesis, gait velocity deficit is associated with a disturbed voluntary movement caused especially by inappropriate antagonist muscle activation. The present study investigates muscles cocontraction at the paretic ankle estimated with a pair of and multi-channel surface EMG (HD-EMG) in patients after stroke. HD-EMGs were collected from gastrocnemius medialis (GM), tibialis anterior (TA) and soleus (SO) during isometric contractions. From these EMGs the study asked whether bipolar and HD-EMGs provided comparable estimates of antagonist activation. Two active contraction levels (submaximal vs. maximal) and knee positions (flexed vs. extended) were assessed for each muscle. Notwithstanding the evidence of localized antagonist activation in the GM muscle of healthy subjects, hypothesizing equally localized antagonist activation in the paretic limb may not follow from the current literature. In virtue of evidence supporting the enlargement of motor unit territories in paretic and hyperactive muscles, it may be that stroke survivors have lost their ability to regionally and appropriately activate their muscle. In this case, bipolar and HD-EMG would be expected to provide comparable antagonist activation coefficients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Person with chronic hemiparesis due to a non-evolutive central nervous system lesion', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* hemiparesis due to a non-evolutive central nervous system lesion\n* time since lesion ≥ 6 months\n* ability to walk 10 meters barefoot without any assistance\n* cognitive abilities to understand the verbal instructions for the test according to the investigator's judgment\n* absence of botulinum toxin injections within the last 3 months prior to enrolment\n\nExclusion Criteria:\n\n* botulinum toxin injections within the last 3 months prior to enrolment"}, 'identificationModule': {'nctId': 'NCT06099132', 'acronym': 'CC2017', 'briefTitle': 'Antagonist Activation Measurement at the Ankle Using High-density and Bipolar Surface EMG in Chronic Hemiparesis', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'Antagonist Activation Measurement at the Ankle Using High-density and Bipolar Surface EMG in Chronic Hemiparesis', 'orgStudyIdInfo': {'id': 'CC2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Electromyographic measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'HD and bipolar EMG were assessed from gastrocnemius medialis (GM), soleus (SO) and tibialis anterior (TA) at seated position, ankle at 0°, during isometric submaximal effort and maximal effort, knee flexed (90°) and knee extended (0°)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emilie Hutin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpitaux Universitaires Henri Mondor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Emilie Hutin', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}