[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05740540":3,"trial-entities:NCT05740540":108,"trial-summary:NCT05740540":111},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":84,"locations":87,"central_contacts":100,"overall_officials":101,"references":106,"see_also_links":107},"NCT05740540","StudyID00000125","Implant for Walking After Stroke","Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke","ACTIVE_NOT_RECRUITING","2027-06-30","2025-09","2026-08-21","2023-05-16","MetroHealth Medical Center","OTHER",true,"This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.","The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.",[19,20,21],"Stroke","Hemiplegia","Gait, Hemiplegic",[],"INTERVENTIONAL","DEVICE_FEASIBILITY",[26],"NA",{"count":28,"type":29},6,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","IRS-8","Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only",[36],"Implantation, controller development, and evaluation",{"type":32,"name":38,"description":39,"armGroupLabels":40},"IST 12 & IST 16","Implantable Stimulator Telemeter (IST) that provides 12 independent channels of stimulation with the option of 2 channels of bipolar myoelectric signal recording, or 16 independent stimulus channels. Suitable for muscle-based or nerve cuff electrodes such as the CWRU Spiral, Flat Interface Nerve Electrode (FINE) or Composite-Flat Interface Nerve Electrode (C-FINE).",[36],[42],{"measure":43,"description":44,"timeFrame":45},"Difference in Gait speed","The 10mWT is used to assess walking speed in meters\u002Fsecond (m\u002Fs) over a short distance.\n\nGait speed is how we're evaluating whether the advanced controller works better than a simple generic triggering approach.","baseline, ~18 weeks post implant, ~44 week post implant",[47],{"measure":48,"description":49,"timeFrame":50},"Difference in Usability Rating Scale (URS)","participants will rate the task on a seven-point scale from \"very easy\" (3) to \"very difficult\" (-3). Difficulty will be assessed after the 10 m walk test","baseline, ~18 weeks post implant, ~44-week post implant","ALL","21 Years","75 Years",false,{"inclusion":56,"exclusion":69,"raw_text":83},[57,58,59,60,61,62,63,64,65,66,67,68],"At least 6-months post stroke","Age 21 to 75 years old","Able to ambulate, but does not require the assistance of more than one person","Walk slower than 0.8m\u002Fs during a 10m walk test","Lower extremity Fugl-Meyer Motor Assessment (FMA) \\\u003C= 20","Reduced peak hip, knee and\u002For ankle range of motion during stance or swing phases","Modified Ashworth Scale (MAS) \\\u003C= 2 at the above joints during passive flexion and extension","Innervated and excitable lower extremity and trunk musculature","Appropriate body habitus (height and weight within acceptable limits as determined by study physician)","Adequate social support and stability","Willingness to comply with follow-up procedures","Neurologically stable as determined by a physician",[70,71,72,73,74,75,76,77,78,79,80,81,82],"Non-English speaking","Significant range of motion limitations (lacking hip extension, etc.)","History of spontaneous fractures or other evidence of excessively low bone density","Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)","Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological\u002Fpulmonary\u002Frenal\u002Fcirculatory compromise, additional neurologic conditions etc.)","Cardiovascular or pulmonary disease","Uncontrolled diabetes or hypertension","Presence of a demand pacemaker or cardiac defibrillator","Pregnancy","Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)","Significant history of repeated falls","Severely impaired cognition and communication","Any other medical or psychological condition that would be a contraindication","Inclusion Criteria:\n\n* At least 6-months post stroke\n* Age 21 to 75 years old\n* Able to ambulate, but does not require the assistance of more than one person\n* Walk slower than 0.8m\u002Fs during a 10m walk test\n* Lower extremity Fugl-Meyer Motor Assessment (FMA) \\\u003C= 20\n* Reduced peak hip, knee and\u002For ankle range of motion during stance or swing phases\n* Modified Ashworth Scale (MAS) \\\u003C= 2 at the above joints during passive flexion and extension\n* Innervated and excitable lower extremity and trunk musculature\n* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)\n* Adequate social support and stability\n* Willingness to comply with follow-up procedures\n* Neurologically stable as determined by a physician\n\nExclusion Criteria:\n\n* Non-English speaking\n* Significant range of motion limitations (lacking hip extension, etc.)\n* History of spontaneous fractures or other evidence of excessively low bone density\n* Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)\n* Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological\u002Fpulmonary\u002Frenal\u002Fcirculatory compromise, additional neurologic conditions etc.)\n* Cardiovascular or pulmonary disease\n* Uncontrolled diabetes or hypertension\n* Presence of a demand pacemaker or cardiac defibrillator\n* Pregnancy\n* Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)\n* Significant history of repeated falls\n* Severely impaired cognition and communication\n* Any other medical or psychological condition that would be a contraindication",[85,86],"ADULT","OLDER_ADULT",[88,97],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"Louis Stokes Cleveland Veterans Affairs Medical Center","Cleveland","Ohio","44106","United States",{"lat":95,"lon":96},41.4995,-81.69541,{"facility":13,"city":90,"state":91,"zip":98,"country":93,"geoPoint":99},"44109",{"lat":95,"lon":96},[],[102],{"name":103,"affiliation":104,"role":105},"Nathan Makowski, PhD","MetroHealth System, Ohio","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[19],[],{"nct_id":4,"found":15,"summary":112,"prompt_version":121},{"design":113,"status":114,"heading":6,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional study that plans to enroll 6 participants. It is a device study, not a drug study.","completed","This study is testing if an implanted device can help improve walking for people who have had a stroke. The devices, called IRS-8, IST 12, or IST 16, are surgically placed to send electrical signals to muscles involved in walking. Researchers will measure your walking speed before the implant, and again about 18 weeks and 44 weeks after the implant, to see if it helps. You might be able to join if you are 21-75 years old, had a stroke at least six months ago, can walk with some help, and walk slower than 0.8 meters per second. The study is currently recruiting a small number of participants.","Your walking speed will be measured at baseline, about 18 weeks after the implant, and about 44 weeks after the implant.",108,"You would undergo screening, surgery to implant the device, training to use it at home, and follow-up evaluations over several months.","Not stated in the trial record.",[33],"v2"]