Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT02917850
Status:
WITHDRAWN
Last Update Posted:
2018-09-13
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'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': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Max gait speed (m/s)', 'timeFrame': '6 weeks', 'description': 'Gait speed will be assessed in the 10m walk test'}], 'secondaryOutcomes': [{'measure': 'Max gait speed (m/s)', 'timeFrame': '3 and 6 months', 'description': 'Gait speed will be assessed in the 10m walk test'}, {'measure': 'Hip flexors strength', 'timeFrame': '6weeks; 3 and 6 months', 'description': 'Hip flexors strength will be evaluated using an isokinetic dynamometer (concentric, 30°/s) and motor testing (medical research council)'}, {'measure': 'Gait endurance', 'timeFrame': '6 weeks; 3 and 6 months', 'description': 'Gait endurance will be assessed using the 6MWT'}, {'measure': 'Gait capacities', 'timeFrame': '6 weeks; 3 and 6 months', 'description': 'Functional ambulation categories (FAC)'}, {'measure': 'Balance and postural control', 'timeFrame': '6 weeks; 3 and 6 months', 'description': 'Postural Assessment for Stroke Scale (PASS)'}, {'measure': 'Balance and postural control', 'timeFrame': '6 weeks; 3 and 6 months', 'description': 'Timed-up and go test'}, {'measure': 'Rate of perceived exhaustion during gait', 'timeFrame': '6 weeks; 3 and 6 months', 'description': 'Borg scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'gait', 'hip flexors', 'paresis', 'hemiplegia'], 'conditions': ['Stroke', 'Hemiplegia', 'Gait']}, 'descriptionModule': {'briefSummary': 'Post-stroke patients often present with gait disorders due to several physical impairments. Hip flexor deficit is one of the more prevalent trouble and is associated with gait capacities. This study aims at evaluating the impact of an isokinetic hip flexors strengthening rehabilitation program in the subacute phase after stroke. Patients will be randomized to an intervention group (isokinetic rehabilitation) or a control group (conventional rehabilitation) and assessed at the end of the rehabilitation program, at 3 and at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from a first ever stroke\n* At the subacute phase\n* Able to walk at least 10m with or without assistive devices\n* Hip flexors strength on the paretic side \\> 2/5 (MRC)\n\nExclusion Criteria:\n\n* Uncontrolled epilepsy\n* Contraindications to physical activity (severe arterial hypertension, aortic valvulopathy, severe PAD...)\n* History of muscular or joint disorders on the paretic hip\n* Subject unable to deliver an informed written consent (due to aphasia, cognitive or psychiatric disorders...)\n* Protected persons\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02917850', 'acronym': 'ISOKINETIC', 'briefTitle': 'Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Impact of Hip Flexors Isokinetic Strengthening on Gait Capacities in Subacute Stroke Patients', 'orgStudyIdInfo': {'id': '2015_32'}, 'secondaryIdInfos': [{'id': '2016-A00366-45', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isokinetic', 'description': 'Patients who benefit from the hip flexors isokinetic strengthening rehabilitation program', 'interventionNames': ['Procedure: Isokinetic hip flexors strengthening', 'Procedure: Conventional rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients who benefit from a conventional rehabilitation program', 'interventionNames': ['Procedure: Conventional rehabilitation']}], 'interventions': [{'name': 'Isokinetic hip flexors strengthening', 'type': 'PROCEDURE', 'description': 'Isokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w.', 'armGroupLabels': ['Isokinetic']}, {'name': 'Conventional rehabilitation', 'type': 'PROCEDURE', 'description': 'Conventional rehabilitation 10/w during 6 weeks', 'armGroupLabels': ['Control', 'Isokinetic']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Etienne Allart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}