Nctid:
NCT06230796
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010291", "term"=>"Paresis"}], "ancestors"=>[{"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"M20944", "name"=>"Muscle Weakness", "relevance"=>"LOW"}, {"id"=>"M13204", "name"=>"Paresis", "asFound"=>"Hemiparesis", "relevance"=>"HIGH"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Sham stimulation"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-17", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"VO2 peak at 2 months (L/min)", "timeFrame"=>"From enrollment to the end of treatment at 8 weeks", "description"=>"Comparison of the maximum oxygen consumption (VO2 peak in L/min) measured during an incremental maximum stress test on cyclo-ergometer between the end of training (M2) and inclusion (M0)."}], "secondaryOutcomes"=>[{"measure"=>"Maximum power", "timeFrame"=>"2 months", "description"=>"Comparison of the maximum power (in Watts) developed during the stress test on a cycloergometer between the end of the training (M2) and the inclusion (M0)"}, {"measure"=>"Walking ability", "timeFrame"=>"4 months", "description"=>"walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)"}, {"measure"=>"quadriceps muscular thickness", "timeFrame"=>"2 months", "description"=>"quadriceps muscular thickness measured with ultrasound at inclusion aand after the training"}, {"measure"=>"Middle Cerebral Artery Blood Flow Velocity During Exercise", "timeFrame"=>"2 months", "description"=>"Middle Cerebral Artery Blood Flow Velocity During Exercise measured with transcranial Doppler ultrasound at inclusion (M0) and after the training (M2)"}, {"measure"=>"Cognitive function", "timeFrame"=>"2 months", "description"=>"Paper test: Stroop and trail making test at inclusion and after training"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["cycling", "exercises", "functional electrical stimulation"], "conditions"=>["Hemiparesis;Poststroke/CVA"]}, "descriptionModule"=>{"briefSummary"=>"To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis", "detailedDescription"=>"Design: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.\n\nSetting: Neurologic Rehabilitation Unit Interventions: 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).\n\nIn addition to the assigned group treatment, subjects will perform their own standard rehabilitation program.\n\nParticipants will be evaluated before training, after training, and at 3 month follow-up visit"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adults with Hemiparesis after an unilateral first ever stroke\n* Able to walk in security\n* Time since stroke within 3 months to 1 year\n* Sufficient cognitive function to understand and perform corresponding tasks\n\nExclusion Criteria:\n\n* Any history of neurological disorders or cardiovascular instability\n* High spasticity on ankle, knee, hip muscles\n* Inability to exercise on a cyclo-ergometer\n* Pacemaker and other contraindications of the use of electrical stimulation"}, "identificationModule"=>{"nctId"=>"NCT06230796", "acronym"=>"AVCyclES", "briefTitle"=>"Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke", "organization"=>{"class"=>"OTHER", "fullName"=>"UGECAM Rhône-Alpes"}, "officialTitle"=>"Effects of FES-cycling in Patients With Hemiparesis After Stroke", "orgStudyIdInfo"=>{"id"=>"2023-01-VR"}, "secondaryIdInfos"=>[{"id"=>"2023-A00627-38", "type"=>"OTHER", "domain"=>"ID-RCB"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"FES-cycling", "description"=>"30 minutes of active leg cycling with FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks", "interventionNames"=>["Device: FES-cycling"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"SHAM-cycling", "description"=>"30 minutes of active leg cycling with Sham FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks", "interventionNames"=>["Device: SHAM-cycling"]}], "interventions"=>[{"name"=>"FES-cycling", "type"=>"DEVICE", "description"=>"30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).", "armGroupLabels"=>["FES-cycling"]}, {"name"=>"SHAM-cycling", "type"=>"DEVICE", "description"=>"30 minutes of active leg cycling with SHAM FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).", "armGroupLabels"=>["SHAM-cycling"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"69370", "city"=>"Saint didier au mont d'or", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"julie di marco, MD", "role"=>"CONTACT", "email"=>"dr.jdimarco@gmail.com", "phone"=>"01133472532161"}, {"name"=>"julie di marco, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"SMR Val Rosay", "geoPoint"=>{"lat"=>45.817, "lon"=>4.79672}}], "centralContacts"=>[{"name"=>"julie Di marco, MD", "role"=>"CONTACT", "email"=>"dr.jdimarco@gmail.com", "phone"=>"01133472532161"}, {"name"=>"Sarah Finel", "role"=>"CONTACT", "email"=>"secmedhdj.valrosay@ugecam.assurance-maladie.fr"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"UGECAM Rhône-Alpes", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
