Nctid:
NCT06234878
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000020233", "term"=>"Gait Disorders, Neurologic"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M22058", "name"=>"Gait Disorders, Neurologic", "asFound"=>"Gait Disorders, Neurologic", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"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"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2023-12-15", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Walking speed measure precision", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of walking speed measured with REEV SENSE with reference method"}], "secondaryOutcomes"=>[{"measure"=>"KPP (Knee Position Predictor) measure precision = precision of the predicted angle of knee sagittal flexion in the next 200ms", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of KPP measured with REEV SENSE with reference method."}, {"measure"=>"Walking cadence measure precision = precision of the number of steps per minute", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of walking cadence measured with REEV SENSE with reference method"}, {"measure"=>"Stride length measure precision", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of stride length measured with REEV SENSE with reference method"}, {"measure"=>"Swing time measure precision", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of swing time measured with REEV SENSE with reference method"}, {"measure"=>"Stance time measure precision", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of stance time measured with REEV SENSE with reference method"}, {"measure"=>"Stance symmetry measure precision = precision of the % of unilateral stance time predominance (right or left) compared to total bilateral stance time (right and left)", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of stance symmetry measured with REEV SENSE with reference method"}, {"measure"=>"Knee flexion angle measure precision in sagittal plan", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of knee flexion measured with REEV SENSE with reference method"}, {"measure"=>"Ankle flexion angle measure precision in sagittal plan", "timeFrame"=>"Throughout study completion (an average of 2h)", "description"=>"Comparison of ankle flexion angle measured with REEV SENSE with reference method"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Stroke", "Gait analysis", "Accelerometer", "Gait impairment"], "conditions"=>["Stroke", "Gait Disorders, Neurologic"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.\n\nREEV SENSE is intended to be used by trained healthcare professionals as a simple procedure adapted to clinical routine.\n\nThe reference method for performance comparison will be motion capture.", "detailedDescription"=>"REEV SENSE is a medical device, with pending FDA and CE certifications in class 1. It is a connected gait tracker set primarily on the leg or foot, and eventually on lower limb locations. It contains an accelerometer, a certified standard battery and motion analysis algorithms that will rapidly compute easy-to-use walking analyses accessible to healthcare professionals on a mobile app.\n\nStandard gait biomarkers such as velocity, stride length, or stance and swing times will be computed. However, REEV has also developed a new biomarker, the knee position predictor (KPP), which will provide a more accurate quantification of each individual gait profile.\n\nThe present REEV SENSE study is the first to test subjects with a pathological context, i.e. with post-stroke ambulation deficit. Performance of REEV SENSE has already been established in healthy volunteers in comparison to the reference motion capture system, indicating good technical and metrological performance.\n\nThe study will take place at the MIT Center for Clinical and Translational Research (CCTR), a reference center with a fully equipped gait lab.\n\nEach participating volunteer will be equipped with REEV SENSE and the reference motion capture system. The participant will be asked to walk at a comfortable self selected pace for about 15 minutes back and forth along a 10m walkway. He or she may rest at any time during the walking session. REEV SENSE and motion capture data will be recorded automatically and simultaneously during the same walking session."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Post-stroke gait disorder.\n* Must be able to walk independently with or without the support of a cane or rollator.\n* History of stroke more than six months ago.\n* Be 18 years of age or older.\n\nExclusion Criteria:\n\n* Subject unable to give consent.\n* Subject unable to understand the tests."}, "identificationModule"=>{"nctId"=>"NCT06234878", "acronym"=>"SENS-AG", "briefTitle"=>"REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"REEV LLC"}, "officialTitle"=>"Validation of REEV SENSE Biomarkers Precision for Gait Analysis in Subjects With Post-stroke Gait Impairment", "orgStudyIdInfo"=>{"id"=>"REEV-RS-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Gait analysis", "description"=>"Gait analysis with the investigational and the reference devices", "interventionNames"=>["Device: REEV SENSE", "Device: Motion capture system"]}], "interventions"=>[{"name"=>"REEV SENSE", "type"=>"DEVICE", "description"=>"Gait analysis with an Inertial Measurement Unit (IMU) sensor", "armGroupLabels"=>["Gait analysis"]}, {"name"=>"Motion capture system", "type"=>"DEVICE", "description"=>"Gait analysis with reflective markers and pressure sensors", "armGroupLabels"=>["Gait analysis"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02139", "city"=>"Cambridge", "state"=>"Massachusetts", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Catherine Ricciardi, DNP", "role"=>"CONTACT", "email"=>"c_ricci@mit.edu", "phone"=>"978-618-6954"}, {"name"=>"Tatiana Urman, MSN", "role"=>"CONTACT", "email"=>"tlevko@mit.edu"}], "facility"=>"MIT Center for Clinical and Translational Research", "geoPoint"=>{"lat"=>42.3751, "lon"=>-71.10561}}], "centralContacts"=>[{"name"=>"Amaury Ciurana, MS", "role"=>"CONTACT", "email"=>"amaury.ciurana@reev.care", "phone"=>"8572109698"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"REEV LLC", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
