[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06176833":3,"trial-entities:NCT06176833":139,"trial-summary:NCT06176833":143},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":81,"locations":85,"central_contacts":127,"overall_officials":130,"references":133,"see_also_links":138},"NCT06176833","STU00219541","Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury","Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training","RECRUITING","2029-12","2026-07","2026-07-06","2024-03-21","Milap Sandhu","OTHER",true,"The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.\n\nThe study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.",null,[19],"Spinal Cord Injuries",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},108,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":37},"PROCEDURE","Body Weight Supported Treadmill Training","For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.",[34,35,36],"Chronic Intervention","Early Intervention","Sub-acute Intervention",[38],"BWSTT",[40],{"measure":41,"description":42,"timeFrame":43},"10 Meter walk test","Used to assess walking speed, time taken to walk 10 meters at fastest pace","1-5 days Following Intervention",[45,48,52,56],{"measure":46,"description":47,"timeFrame":43},"6 Minute Walk test","Used to assess distance traveled during a 6 minute walking test at a self selected pace",{"measure":49,"description":50,"timeFrame":51},"Walking Index for spinal cord injury","Assessment to determine the physical assistance and assistive devices needed to walk 10 meters","1-5 days following intervention",{"measure":53,"description":54,"timeFrame":55},"Daily step counts","Step counts from a waist worn activity tracker","2 weeks following 3-, 6-, 9-, and 12- month assessments",{"measure":57,"description":58,"timeFrame":59},"Gait Deviation idex","A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system","Baseline, 3-, 6-, 9-, and 12- month assessments","ALL","16 Years","75 Years",false,{"inclusion":65,"exclusion":73,"raw_text":80},[66,67,68,69,70,71,72],"History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12","Between the ages of 16-74","Weight bearing as tolerated in bilateral lower extremities","Able to tolerate a harness","Ability to provide informed consent. For minors, consent of parents or primary caregivers\u002Fguardians and assent of the minor","Able to provide informed consent within 60 days of injury onset","Able to participate in all study related activities, including 1-year follow up",[74,75,76,77,78,79],"Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing","A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus","Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition","Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.","Other medical complications such as severe heart failure or large\u002Fdeep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation","Pregnancy, as confirmed by blood draw","Inclusion Criteria:\n\n* History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12\n* Between the ages of 16-74\n* Weight bearing as tolerated in bilateral lower extremities\n* Able to tolerate a harness\n* Ability to provide informed consent. For minors, consent of parents or primary caregivers\u002Fguardians and assent of the minor\n* Able to provide informed consent within 60 days of injury onset\n* Able to participate in all study related activities, including 1-year follow up\n\nExclusion Criteria:\n\n* Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing\n* A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus\n* Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition\n* Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.\n* Other medical complications such as severe heart failure or large\u002Fdeep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation\n* Pregnancy, as confirmed by blood draw",[82,83,84],"CHILD","ADULT","OLDER_ADULT",[86,111],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":108},"The Shirley Ryan AbilityLab","Chicago","Illinois","60611","United States",[93,98,102,105],{"name":94,"role":95,"phone":96,"email":97},"Milap Sandhu, Phd","CONTACT","312-238-6529","msandhu@sralab.org",{"name":99,"role":95,"phone":100,"email":101},"Alexander Barry, MS, CCRC","312-238-1435","abarry@sralab.org",{"name":103,"role":104},"Milap Sandhu, PhD","PRINCIPAL_INVESTIGATOR",{"name":106,"role":107},"William Z Rymer, MD, PhD","SUB_INVESTIGATOR",{"lat":109,"lon":110},41.85003,-87.65005,{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":91,"contacts":117,"geoPoint":124},"Baylor Scott and White Institute for Rehabilitation","NOT_YET_RECRUITING","Fort Worth","Texas","76132",[118,122],{"name":119,"role":95,"phone":120,"email":121},"Faith Meza, MPH","214-820-9409","faith.meza@bswhealth.org",{"name":123,"role":104},"Chad Swank, PhD",{"lat":125,"lon":126},32.72541,-97.32085,[128],{"name":99,"role":95,"phone":129,"email":101},"3122381435",[131],{"name":103,"affiliation":132,"role":104},"Shirley Ryan AbilityLab",[134],{"pmid":135,"type":136,"citation":137},"39702102","DERIVED","Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186\u002Fs12883-024-03980-x.",[],{"nct_id":4,"conditions":140,"biomarkers":142},[141],"Spinal Cord Injury",[],{"nct_id":4,"found":15,"summary":144,"prompt_version":153},{"design":145,"status":146,"heading":6,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is an interventional study planning to enroll 108 participants. It will compare the effects of Body Weight Supported Treadmill Training (BWSTT) when started at different times.","completed","This study is looking at how a specific type of walking therapy, called Body Weight Supported Treadmill Training (BWSTT), affects walking ability after a traumatic spinal cord injury. BWSTT involves wearing a harness for support while walking on a treadmill. Researchers want to see if starting this therapy at different times within the first six months after injury changes how well it works. You might be able to join if you are between 16 and 74 years old, have a recent traumatic spinal cord injury, can put some weight on your legs, and can tolerate wearing a harness. The main goal is to measure your walking ability using a 10-meter walk test shortly after the therapy. The current recruitment status is unclear.","Your walking ability will be measured 1-5 days following the intervention.",122,"Participants will undergo walking training sessions using a harness for body weight support or safety while walking on a treadmill.","Not stated in the trial record.",[31],"v2"]