[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07041775":3,"trial-entities:NCT07041775":138,"trial-summary:NCT07041775":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":46,"secondary_outcomes":51,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":94,"locations":97,"central_contacts":126,"overall_officials":133,"references":136,"see_also_links":137},"NCT07041775","STU00221627","MINT Conditioning to Improve Gait","MINT Conditioning to Improve Post-stroke Gait","RECRUITING","2030-03","2026-06","2026-06-08","2026-06-04","Northwestern University","OTHER",true,"This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.",null,[19,20],"Stroke","Stroke Gait Rehabilitation",[22,23,24,25,26,27],"Stroke rehabilitation","Leg impairment","Walking","Rehabilitation gaming","Muscle biofeedback","Myoelectric interface","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},72,"ESTIMATED",[36,41],{"type":14,"name":37,"description":38,"armGroupLabels":39},"myoelectric interface for neurorehabilitation (MINT) conditioning","Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.",[40],"MINT group",{"type":14,"name":42,"description":43,"armGroupLabels":44},"One muscle myoelectric feedback","Training to control muscle activity in one muscle only.",[45],"Sham group",[47],{"measure":48,"description":49,"timeFrame":50},"10-m walk test","The 10-m walk test measures gait speed","Baseline and 4 weeks",[52,56,58,59,63],{"measure":53,"description":54,"timeFrame":55},"6-min walk test","The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.","Baseline and week 4",{"measure":48,"description":49,"timeFrame":57},"Baseline and week 8",{"measure":53,"description":54,"timeFrame":57},{"measure":60,"description":61,"timeFrame":62},"MINT performance","The mean weighted time-to-target over trials.","each training session",{"measure":64,"description":65,"timeFrame":66},"Target muscle co-activation","The co-activation (correlation) between the targeted muscles daily during training and in the lab sessions during the evaluation times.","Baseline and weeks 4 and 8","ALL","18 Years","85 Years",false,{"inclusion":72,"exclusion":79,"raw_text":93},[73,74,75,76,77,78],"Age at enrollment is 18 to 85","Leg impairment from unilateral stroke at least 6 months prior to screening","Severe to moderate gait impairment (ambulatory with a maximum walking speed of 0.8 m\u002Fs, i.e., half of normal speed)","Able to stand without assistance","Clinically observable gait asymmetry","Abnormal co-activation between adductor magnus and rectus femoris (R greater than or equal to 0.5)",[80,81,82,83,84,85,86,87,88,89,90,91,92],"Cognitive impairment with at least moderately impaired attention on digit-span test, or unable to follow instructions of the MINT task","Visual impairment (such as hemianopia) preventing sufficient perception of the screen to play the games","Anesthesia or severe neglect in the affected leg, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest) that impairs ability to play the games","Participation in another study on the affected leg, or any pharmacological study, within 6 weeks of enrollment","Inability to understand or follow commands in English due to aphasia or other reason that makes it impossible to perform the training","Diffuse or multifocal infarcts","Substantial leg or other pain preventing participation for 60 minutes a day","Spasticity treatment (pharmacological or Botox) on the affected leg within past 3 months","Severe osteoporosis causing hip or other fractures","History of multiple falls within the last year, use of walker for balance, or falling during stance while in the lab in the first session.","Contracture limiting the range of motion of the leg","Current pregnancy","From the TMS portion of the study only: History of epilepsy in adulthood requiring antiseizure medications; recent\u002Fcurrent alcoholism or benzodiazepine\u002Fbarbiturate abuse or recent history of alcohol\u002Fbenzodiazepine\u002Fbarbiturate withdrawal, recent history of cocaine or amphetamine use, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, vagus nerve stimulator, cochlear implant, deep brain stimulator, intracranial\u002Fcarotid stents, cardiac pacemaker\u002FAICD.","Inclusion Criteria:\n\n* Age at enrollment is 18 to 85\n* Leg impairment from unilateral stroke at least 6 months prior to screening\n* Severe to moderate gait impairment (ambulatory with a maximum walking speed of 0.8 m\u002Fs, i.e., half of normal speed)\n* Able to stand without assistance\n* Clinically observable gait asymmetry\n* Abnormal co-activation between adductor magnus and rectus femoris (R greater than or equal to 0.5)\n\nExclusion Criteria:\n\n* Cognitive impairment with at least moderately impaired attention on digit-span test, or unable to follow instructions of the MINT task\n* Visual impairment (such as hemianopia) preventing sufficient perception of the screen to play the games\n* Anesthesia or severe neglect in the affected leg, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest) that impairs ability to play the games\n* Participation in another study on the affected leg, or any pharmacological study, within 6 weeks of enrollment\n* Inability to understand or follow commands in English due to aphasia or other reason that makes it impossible to perform the training\n* Diffuse or multifocal infarcts\n* Substantial leg or other pain preventing participation for 60 minutes a day\n* Spasticity treatment (pharmacological or Botox) on the affected leg within past 3 months\n* Severe osteoporosis causing hip or other fractures\n* History of multiple falls within the last year, use of walker for balance, or falling during stance while in the lab in the first session.\n* Contracture limiting the range of motion of the leg\n* Current pregnancy\n* From the TMS portion of the study only: History of epilepsy in adulthood requiring antiseizure medications; recent\u002Fcurrent alcoholism or benzodiazepine\u002Fbarbiturate abuse or recent history of alcohol\u002Fbenzodiazepine\u002Fbarbiturate withdrawal, recent history of cocaine or amphetamine use, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, vagus nerve stimulator, cochlear implant, deep brain stimulator, intracranial\u002Fcarotid stents, cardiac pacemaker\u002FAICD.",[95,96],"ADULT","OLDER_ADULT",[98,112],{"facility":13,"status":8,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":109},"Chicago","Illinois","60611","United States",[104],{"name":105,"role":106,"phone":107,"email":108},"Study Principal Investigator","CONTACT","312-503-4653","mslutzky@northwestern.edu",{"lat":110,"lon":111},41.85003,-87.65005,{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":102,"contacts":118,"geoPoint":123},"University of Texas Southwestern Medical Center","NOT_YET_RECRUITING","Dallas","Texas","75390",[119],{"name":120,"role":106,"phone":121,"email":122},"Yasin Dhaher, PhD","847-331-0793","yasin.dhaher@utsouthwestern.edu",{"lat":124,"lon":125},32.78306,-96.80667,[127,129],{"name":128,"role":106,"phone":107,"email":108},"Marc Slutzky, MD, PhD",{"name":130,"role":106,"phone":131,"email":132},"Cynthia Gorski","312-503-6097","cynthia.gorski@northwestern.edu",[134],{"name":128,"affiliation":13,"role":135},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":139,"biomarkers":140},[19],[],{"nct_id":4,"found":15,"summary":142,"prompt_version":152},{"design":143,"status":144,"heading":145,"summary":146,"follow_up":147,"word_count":148,"commitments":149,"compensation":150,"drugs_mentioned":151},"This interventional study plans to enroll 72 participants. It is testing two different training methods.","completed","MINT Conditioning to Improve Gait After Stroke","This study is testing two training methods to improve walking for people who have had a stroke. One method is called myoelectric interface for neurorehabilitation (MINT) conditioning, which aims to reduce abnormal muscle co-activation (when muscles work against each other). The other method is training to control activity in just one muscle. You might be able to join if you are 18-85 years old, had a stroke at least six months ago that affects your leg, have moderate to severe difficulty walking, can stand on your own, and show abnormal muscle co-activation. The study will measure how far you can walk in 10 meters at the start and after four weeks to see if the training helps. The study plans to enroll 72 participants, but its current status is unclear.","Your walking ability will be measured at the start of the study and again after 4 weeks.",130,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]