Nctid:
NCT06232512
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006987", "term"=>"Hypesthesia"}], "ancestors"=>[{"id"=>"D000020886", "term"=>"Somatosensory Disorders"}, {"id"=>"D000012678", "term"=>"Sensation Disorders"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M10038", "name"=>"Hypesthesia", "asFound"=>"Hypoesthesia", "relevance"=>"HIGH"}, {"id"=>"M22625", "name"=>"Somatosensory Disorders", "relevance"=>"LOW"}, {"id"=>"M15490", "name"=>"Sensation Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-04-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2023-12-21", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-07-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pressure data from the insoles", "timeFrame"=>"During the intervention", "description"=>"The primary outcome is to use the pressure-sensitive insole to ensure that we can accurately record spatial and temporal pressure data from a wide variety of healthy and non-healthy individuals."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Plantar Sensation"], "conditions"=>["Hypoesthesia"]}, "descriptionModule"=>{"briefSummary"=>"The study will explore the use of a haptic device for sensory substitution in individuals with a movement disorder that has caused loss of plantar sensation. The haptic device consists of two components. The first element is a flexible insole with embedded pressure-sensing elements that transmit the spatial patterns of applied foot pressure over time. The second element is a haptic receiver with embedded actuators that vibrate or heat up in proportion to the transmitted pressure patterns, thus substituting the patient's lost plantar sensation.", "detailedDescription"=>"OBJECTIVES:\n\n1. Identify a systematic, methodical approach to determine whether different users of our haptic device can perceive and use vibrational and thermal feedback in order to correct their posture in real-time.\n2. Evaluate whether a haptic device can be used to guide users to maintain a prescribed pattern of pressure on their feet during standing and walking.\n3. Investigate whether a haptic device can improve outcomes on motor evaluation tasks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Able to ambulate 10 meters with or without assistance\n* Able and willing to give written consent and comply with study procedures\n\nExclusion Criteria:\n\n* Unable to give written consent or comply with study procedures\n* Unable to perceive unsafe levels of heat in relevant areas\n* Has a motor complete spinal cord injury\n* Have transfemoral (above knee) amputation\n* Any condition that would prevent the safe completion of study activities, as determined by the Principal Investigator"}, "identificationModule"=>{"nctId"=>"NCT06232512", "briefTitle"=>"Multimodal Haptic Feedback for Plantar Sensory Substitution", "organization"=>{"class"=>"OTHER", "fullName"=>"Shirley Ryan AbilityLab"}, "officialTitle"=>"Multimodal Haptic Feedback for Plantar Sensory Substitution", "orgStudyIdInfo"=>{"id"=>"STU00218277"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Exploratory Arm", "description"=>"Individuals will complete standardized balance and walking tasks with and without sensory substitution from the haptic device system.", "interventionNames"=>["Device: Haptic Device"]}], "interventions"=>[{"name"=>"Haptic Device", "type"=>"DEVICE", "description"=>"Provides sensory substitution by mapping pressure from the insole sensor onto a corresponding vibrating and heating patch to be worn where more sensation is present.", "armGroupLabels"=>["Exploratory Arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Shreya Aalla, BS", "role"=>"CONTACT", "email"=>"saalla@sralab.org", "phone"=>"312-238-7323"}], "facility"=>"Shirley Ryan AbilityLab", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}], "centralContacts"=>[{"name"=>"Shreya Aalla, BS", "role"=>"CONTACT", "email"=>"saalla@sralab.org", "phone"=>"312-238-7323"}, {"name"=>"Sara Prokup, DPT", "role"=>"CONTACT", "email"=>"sprokup@sralab.org", "phone"=>"312-238-1255"}], "overallOfficials"=>[{"name"=>"Arun Jayaraman, PT, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Shirley Ryan AbilityLab"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shirley Ryan AbilityLab", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Querrey Simpson Institute for Bioelectronics", "class"=>"UNKNOWN"}, {"name"=>"Northwestern University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Arun Jayaraman, PT, PhD", "investigatorAffiliation"=>"Shirley Ryan AbilityLab"}}}}
