protocolSection identificationModule nctId: NCT06273475, orgStudyIdInfo id: OUH RoboRehab, briefTitle: Robot-Assisted Training Versus Standard Training in Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: University of Southern Denmark, collaborators name: Rigshospitalet, Denmark, collaborators name: Herlev and Gentofte Hospital, collaborators name: Stanford University, collaborators name: Sygehus Lillebaelt, collaborators name: Danish Association of the Physically Disabled, descriptionModule briefSummary: The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.The main hypothesis of the study is:Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training., conditionsModule conditions: Stroke, conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Robot-assisted Training, interventions name: Standard Training, outcomesModule primaryOutcomes measure: Fugl-Meyer Lower Extremity Assessment of Motor Function, secondaryOutcomes measure: Modified Rankin Scale Score (between-group change), secondaryOutcomes measure: Functional Ambulation Category (between-group change), secondaryOutcomes measure: Berg Balance Scale (between-group change), secondaryOutcomes measure: Barthel-100 Index (between-group change), secondaryOutcomes measure: Global Rating of Change (between-group change), secondaryOutcomes measure: International Physical Activity Questionnaire - Short Form (between-group change), secondaryOutcomes measure: Fatigue Severity Scale 7 (between-group change), secondaryOutcomes measure: EQ-5D-5L Quality of Life (between-group change), secondaryOutcomes measure: Hand-grip strength (between-group change), secondaryOutcomes measure: Gait speed (between-group change), otherOutcomes measure: Contractile Muscle Power (between-group change), otherOutcomes measure: Modified Sit-to-Stand Test (between-group change), otherOutcomes measure: Blood Biomarkers (between-group change), otherOutcomes measure: Modified Ashworth Scale (between-group change)., otherOutcomes measure: Oxford Cognitive Screen (between-group change), otherOutcomes measure: Montreal Cognitive Assessment (between-group change), otherOutcomes measure: Major Depression Inventory (between-group change), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet and Herlev Gentofte Hospital, status: NOT_YET_RECRUITING, city: Copenhagen, country: Denmark, contacts name: Jon Skovgaard Jensen, Ph.d.-student, role: CONTACT, email: jskovgaard@health.sdu.dk, contacts name: Christina Rostrup Kruuse, Professor, MD, PhD, DMSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Odense University Hospital, status: RECRUITING, city: Odense, country: Denmark, contacts name: Jon Skovgaard Jensen, Ph.d.-student, role: CONTACT, email: jskovgaard@health.sdu.dk, contacts name: Anders Holsgaard-Larsen, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False