Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06107556
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D010291', 'term': 'Paresis'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077107', 'term': 'Gait Analysis'}], 'ancestors': [{'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000076604', 'term': 'Physical Functional Performance'}, {'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coefficient of antagonist activation', 'timeFrame': '1 year', 'description': 'The coefficient of antagonist activation of gastrocnemius medialis and soleus was calculated from EMG data 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', 'Walking, Difficulty', 'Spasticity/Paresis']}, 'descriptionModule': {'briefSummary': 'The retrospective study investigates the part of responsibility of neuromuscular disorders associated with chronic hemiparesis in walking impairment.', 'detailedDescription': 'After injury to the central nervous system, walking disorders are associated with complex neuromuscular mechanisms that alter the direction and intensity of the descending control, reflex reactions to kinematic changes and the mechanical components of soft tissues. The dissociated analysis of these mechanisms and their interactions during multi-segmental movements and especially during walking is poorly described. However, a quantified assessment of the responsibility of each of the neuromuscular mechanisms in the functional disorder would guide the choice of treatments. 3D gait laboratories provide kinematic data from synchronized walking to surface electromyograms as part of additional assessments to assist in the follow-up of patients with chronic hemiparesis. Retrospective analysis of these data would help to better characterize muscular activation disorders and passive resistance to movement during walking in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Person with a history of stroke', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Person who performed tridimensional gait analysis in laboratory\n* Person who had a stroke at least 6 months before the gait analysis\n\nExclusion Criteria:\n\n* Any other neurological pathology or gait disorders\n* Botulinum toxin injection in the last 3 months before the gait analysis'}, 'identificationModule': {'nctId': 'NCT06107556', 'acronym': 'NEUROGAIT', 'briefTitle': 'Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'Neuromechanical Characterization of Agonist and Antagonist Muscle Activations in the Lower Limbs During Walking After Central Nervous System Injury', 'orgStudyIdInfo': {'id': '2023-A02258-37'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gait analysis', 'type': 'DIAGNOSTIC_TEST', 'description': '3D gait analysis with electromyographic measurements'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Créteil', 'country': 'France', 'facility': 'Laboratoire Analyse et Restauration du Mouvement', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Emilie Hutin, Ph.D.', 'role': 'CONTACT', 'email': 'emilie.hutin@aphp.fr', 'phone': '0149812549'}, {'name': 'Emilie Hutin', 'role': 'CONTACT', 'email': 'emilie.hutin@aphp.fr', 'phone': '0149812549'}], 'overallOfficials': [{'name': 'Emilie Hutin', 'role': 'PRINCIPAL_INVESTIGATOR', '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'}}}}