Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT05264103
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2021-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Robotic Assistance on Gait Parameters Among Healthy Subjects and Brain Damaged Patients
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-02-21', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy cost (J.kg/m)', 'timeFrame': '1 week', 'description': 'A nasal mask is fitted to the subject to measure oxygen consumption (VO2) and carbon dioxide production (VCO2). The ratio between VCO2 and VO2 is used to calculate the respiratory exchange ratio (RER). The Joules of energy expended per liter of oxygen consumed were computed depending on the RER. RER is assessed in a standing and walking condition. Finally, the energy cost is obtained by the ratio "walking expended minus standing\'\' divided by speed.'}], 'secondaryOutcomes': [{'measure': 'Temporo-spatial parameters of gait: step length', 'timeFrame': '1 week', 'description': 'Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to asess step length (m).'}, {'measure': 'Temporo-spatial parameters of gait: stance phase', 'timeFrame': '1 week', 'description': 'Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to assess stance phase (%).'}, {'measure': 'Temporo-spatial parameters of gait: cadence', 'timeFrame': '1 week', 'description': 'Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to assess cadence (step/min).'}, {'measure': 'Segmental kinematics of gait (°)', 'timeFrame': '1 week', 'description': 'Reflective landmarks positioned on precise anatomic sites were used to compute kinematic variables. Data from landmarks are collected with 8 infra-red camera. From Euler angles, it allowed the computation of angular displacements of the pelvis, hip, knee and ankle in the three planes of space.'}, {'measure': 'Muscle activation', 'timeFrame': '1 week', 'description': 'Electrodes are placed on different muscles to record muscles activity.'}, {'measure': 'Mechanical work (J.kg/m)', 'timeFrame': '1 week', 'description': 'The total positive mechanical work performed by the muscles during gait is calculated by the sum of external work (performed to move the body center of mass) and internal work (performed to move the body segments relative to the body center of mass)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to quantitatively assess the robotic assistance given by an exoskeleton on patients gait parameters. Patients will be asked to walk with- and without the exoskeleton on a treadmill. During the study, the biomechanical and the energy consumption will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiparesis due to stroke\n* Min 18 years\n* Time since stroke \\> 15 days\n* Ability to understand instructions\n* Ability to do gait analysis on the treadmill\n\nExclusion Criteria:\n\n\\- Contraindication for the use of the robot Atalante'}, 'identificationModule': {'nctId': 'NCT05264103', 'acronym': 'MARAT', 'briefTitle': 'Assessment of Robotic Assistance on Gait Parameters Among Healthy Subjects and Brain Damaged Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Assessment of Robotic Assistance on Gait Parameters.', 'orgStudyIdInfo': {'id': '2021/4OCT/404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group.', 'description': 'Healthy subjects and brain damaged patients with gait disorder.', 'interventionNames': ['Device: Exoskeleton for gait rehabilitation (Atalante)']}], 'interventions': [{'name': 'Exoskeleton for gait rehabilitation (Atalante)', 'type': 'DEVICE', 'description': 'Subjects will walk with different levels of assistance given by the robot.', 'armGroupLabels': ['Experimental group.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Thierry Lejeune', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}