Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-04-17 @ 7:55 AM
Study NCT ID:
NCT02279069
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2014-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
4-point vs 4-roll Canne as Walking Aids After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 meters walking test at spontaneous speed', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': '10 meters walking test at fast speed', 'timeFrame': '2 days'}, {'measure': '6 minutes walking test', 'timeFrame': '2 days'}, {'measure': 'Borg scale for perceived exertion', 'timeFrame': '2 days'}, {'measure': 'Visual analogic scale for personal satisfaction', 'timeFrame': '2 days'}, {'measure': 'Energy cost', 'timeFrame': '2 days', 'description': 'Extrapolated from heart rate while walking'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'walking', 'rehabilitation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke patients frequently necessitate walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.\n\nThe aim of our study is to compare gait parameters (gait speed and energy cost) with a classical 4-point canne and with 4-roll canne.', 'detailedDescription': "Stroke patients frequently need walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.\n\nOBJECTIVE To compare the gait parameters with a 4-point canne and with a 4-roll canne METHODS The investigators will recruited stroke patients who necessitate 4 point-canne as walking aids. A 10 meters walking test, a 6 minutes walking test, an estimated energy cost and a patient's satisfaction will be monitored with a 4-point canne (day 1) and with a 4-roll canne (day 2) in a cross-over study. The first tested device will be randomized.\n\nPERSPECTIVE The investigators hope to demonstrate that a 4-roll canne makes possible to walk faster in a safe way after stroke"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* post stroke patient\n* able to walk 10 meters\n\nExclusion Criteria:\n\n* cognitive impairment limiting walking capacities\n* need support when walking'}, 'identificationModule': {'nctId': 'NCT02279069', 'acronym': '4roll', 'briefTitle': '4-point vs 4-roll Canne as Walking Aids After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Mont-Godinne'}, 'officialTitle': 'Comparison Between Classical 4-point Canne and 4-roll Canne on Gait Parameters (Gait Speed and Energy Cost) as Walking Aids After Stroke. A Multicentric Randomized Controled Cross-over Study', 'orgStudyIdInfo': {'id': 'MG-4roll-53/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4-point canne', 'description': 'Stroke patients walk with 4-point canne', 'interventionNames': ['Device: 4-roll canne']}, {'type': 'EXPERIMENTAL', 'label': '4-roll canne', 'description': 'Stroke patients walk with 4-roll canne', 'interventionNames': ['Device: 4-roll canne']}], 'interventions': [{'name': '4-roll canne', 'type': 'DEVICE', 'armGroupLabels': ['4-point canne', '4-roll canne']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Deltombe Thierry', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}], 'overallOfficials': [{'name': 'Thierry Deltombe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Dinant Godinne / UcL Namur'}, {'name': 'Geoffroy Dellicour, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Neurologique William Lennox Ottignies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Mont-Godinne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professeur Clinique', 'investigatorFullName': 'Deltombe Thierry', 'investigatorAffiliation': 'University Hospital of Mont-Godinne'}}}}