Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT03342820
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], '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': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018763', 'term': 'Muscle Fatigue'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cocontraction Index (CCI) between the rectus femoris and the semitendinosus', 'timeFrame': 'one day', 'description': 'ratio of the RMS of a the rectus femoris when acting as antagonist to the effort intended (knee flexion) to the RMS of the same muscle when acting as an agonist during a reciprocal maximal isometric knee flexion effort (500 ms around the peak of rectified EMG'}], 'secondaryOutcomes': [{'measure': 'Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle', 'timeFrame': 'one day', 'description': 'ratio of the RMS of a the vastus medialis, lateralis and intermedius when acting as antagonist to the effort intended (knee flexion) to the RMS of the same muscle when acting as an agonist during a reciprocal maximal isometric knee flexion effort (500 ms around the peak of rectified EMG'}, {'measure': 'Agonist Recruitment Index of the semitendinosus', 'timeFrame': 'one day', 'description': 'ratio of the RMS of a muscle acting as an agonist during a given period to its largest RMS value observed during the 500 ms around its agonist recruitment peak'}, {'measure': 'Isometric peak knee flexion torque', 'timeFrame': 'one day', 'description': 'Isometric peak knee flexion torque assessed by a CONTREX dynamometer'}, {'measure': 'Spasticity of the quadriceps', 'timeFrame': 'one day', 'description': 'Tardieu scale angle'}, {'measure': 'spatio-temporal gait parameters at comfortable speed', 'timeFrame': 'one day', 'description': 'Gait speed'}, {'measure': 'spatio-temporal gait parameters at comfortable speed', 'timeFrame': 'one day', 'description': 'Gait cadence'}, {'measure': 'spatio-temporal gait parameters at comfortable speed', 'timeFrame': 'one day', 'description': 'Step length'}, {'measure': 'Isometric peak knee extension torque', 'timeFrame': 'one day', 'description': 'Isometric peak knee extension torque assessed by a CONTREX dynamometer'}, {'measure': '10 metre walk test (10MWT)', 'timeFrame': 'one day', 'description': 'Assessment of max gait speed'}, {'measure': '2 minute walk test (2MWT)', 'timeFrame': 'one day', 'description': 'Assessment of max walking endurance'}, {'measure': 'perceived exertion at the end of the 2MWT (Borg Scale 6-20)', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Spasticity, Muscle', 'Muscle Fatigue', 'Gait, Hemiplegic']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the amount of co-contractions of this last with the hamstrings during a maximal isometric flexion movement in hemiparetic stroke patients.\n\nThe effect of such a protocol on gait parameters and spasticity of the quadriceps will be evaluated also.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80y\n* Hemiparesis after a first-ever stroke \\> 3 months\n* Spasticity of the quadriceps muscle\n* Quadriceps strength at least at 3/5 (MRC testing)\n* Subject able to walk at least 2min without rest\n* Informed consent\n* Social security affiliation\n\nExclusion Criteria:\n\n* Severe comprehension troubles (language, cognitive or psychiatric disorders)\n* History of previous stroke, locomotor or other neurological disorders\n* Locomotor troubles affecting the paretic arm\n* Contraindication to efforts : cardiac insufficiency, severe aortic valvular stenosis, recent heart failure, non treated high blood pressure, severe peripheral arterial disease\n* Pregnancy or breastfeeding\n* Adult subject to guardianship'}, 'identificationModule': {'nctId': 'NCT03342820', 'acronym': 'COCON', 'briefTitle': 'Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients', 'orgStudyIdInfo': {'id': '2016_50'}, 'secondaryIdInfos': [{'id': '2017_A01605-48', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadriceps muscle fatigue', 'description': 'Quadriceps muscle fatigue', 'interventionNames': ['Procedure: Muscle fatigue']}], 'interventions': [{'name': 'Muscle fatigue', 'type': 'PROCEDURE', 'description': 'Isokinetic quadriceps muscle fatigue of the paretic lower limb', 'armGroupLabels': ['Quadriceps muscle fatigue']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Swynghedauw, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Etienne Allart, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}