Nctid:
NCT06612723
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "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"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11767", "name"=>"Metronidazole", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Functional Gait Assessment", "timeFrame"=>"After 12 weeks", "description"=>"10 item assessment of dynamic balance. Example tasks include walking with head turns, with eyes closed, and walking backwards."}, {"measure"=>"30 second Sit to Stand Test", "timeFrame"=>"After 12 weeks", "description"=>"Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds."}, {"measure"=>"Activity-Specific Balance Confidence (ABC) Scale", "timeFrame"=>"After 12 weeks", "description"=>"This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car."}, {"measure"=>"Oxygen Consumption", "timeFrame"=>"After 12 weeks", "description"=>"Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed."}, {"measure"=>"Medical Outcomes Survey Short-Form 36 (SF-36)", "timeFrame"=>"After 12 weeks", "description"=>"This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities."}, {"measure"=>"Steps per Day", "timeFrame"=>"After 12 weeks", "description"=>"Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for \\~1-2 weeks before beginning the training protocol, during the intervention period, and after completing training protocol to quantify home and community mobility. Participants will also be asked to document their daily minutes walked for exercise, number of walking bouts, where they performed the activity, and subjectively how hard they were working while walking for exercise."}, {"measure"=>"Gait speed", "timeFrame"=>"After 12 weeks", "description"=>"This is an assessment of overground walking speed measured across a distance of \\~20 feet and will be conducted at both self-selected (instructions: \"walk at your usual, comfortable pace\") and fastest (instructions: \"walk as fast as you safely can\") walking speeds on a pressure sensitive mat (speed in m/s; Zeno Walkway)."}], "primaryOutcomes"=>[{"measure"=>"6-minute walk test", "timeFrame"=>"After 12 weeks", "description"=>"Individuals will be asked to \"cover as much ground as possible\" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)"}], "secondaryOutcomes"=>[{"measure"=>"Peak treadmill speed", "timeFrame"=>"After 12 weeks", "description"=>"Individuals will participate in a walking-based graded exercise test. While harnessed for safety, a motorized treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due: 1) requests to stop, 2) unable to keep up with the treadmill and/or loses their balance, 3) absolute exercise test termination criteria provided by ACSM. The highest speed that the individual can walk for a minute at is the peak treadmill speed."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["stroke", "gait", "rehabilitation", "high-intensity", "frequency"], "conditions"=>["Stroke"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.", "detailedDescription"=>"This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Unilateral deficits following stroke \\> 6 months prior; however individuals \\> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \\> 6 months\n* Age 18-85\n* Weight \\< 350 pounds\n* Able to follow 3-step commands\n* Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed\n* Lower extremity Fugl-Meyer \\< 34\n* Medical clearance to participate\n\nExclusion Criteria:\n\n* Evidence of cerebellar ataxia\n* Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.\n* Currently participating in other physical therapy\n* \\>50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months"}, "identificationModule"=>{"nctId"=>"NCT06612723", "acronym"=>"F-ITT", "briefTitle"=>"High vs Low-frequency of High-intensity Training in Chronic Stroke", "organization"=>{"class"=>"OTHER", "fullName"=>"Indiana University"}, "officialTitle"=>"High vs Low-frequency of High-intensity Training in Chronic Stroke", "orgStudyIdInfo"=>{"id"=>"24114"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"High frequency", "description"=>"Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks", "interventionNames"=>["Other: high-intensity gait training", "Behavioral: Physical activity coaching"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Low frequency", "description"=>"Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks", "interventionNames"=>["Other: high-intensity gait training", "Behavioral: Physical activity coaching"]}], "interventions"=>[{"name"=>"high-intensity gait training", "type"=>"OTHER", "description"=>"Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve.", "armGroupLabels"=>["High frequency", "Low frequency"]}, {"name"=>"Physical activity coaching", "type"=>"BEHAVIORAL", "description"=>"Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.", "armGroupLabels"=>["High frequency", "Low frequency"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Christopher Henderson, PhD", "role"=>"CONTACT", "email"=>"henderce@iu.edu", "phone"=>"317-329-2353"}, {"name"=>"Thomas G Hornby, PhD", "role"=>"CONTACT", "email"=>"tghornby@iu.edu", "phone"=>"317-329-2353"}], "overallOfficials"=>[{"name"=>"Thomas G Hornby, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Indiana University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Indiana University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"George Hornby", "investigatorAffiliation"=>"Indiana University"}}}}
