[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Healing Innovations\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":5},"100612195","development-and-efficacy-of-a-novel-cost-effective-gait-training-device-utilized-at-home-for-stroke-survivors-100612195",false,"NCT07250425","Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors","Development of a Novel, Cost-Effective Gait Training Device Utilized at Home for the Neurological Patient Population","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* First-ever ischemic or hemorrhagic stroke confirmed by medical record.\n* 3 months to 5 years post-stroke at time of enrollment.\n* Presence of lower-extremity motor impairment limiting walking function.\n* Able to stand for at least 30 minutes with no more than minimal assistance (with or without a device).\n* Medically stable and cleared by a physician to participate in moderate-intensity ambulation exercise.\n* Living in a home environment that can safely accommodate device installation (e.g., adequate space, appropriate flooring, and power access) as determined by the study team.\n* Able to understand study procedures and provide informed consent (or have a legally authorized representative), with sufficient cognitive and communication skills to follow simple instructions.\n* If assistance is required for transfers or device set-up, availability of a caregiver or assistant willing to participate in training and device use.\n\nExclusion Criteria:\n\n* Unstable cardiovascular, respiratory, or other medical conditions that contraindicate moderate- to high-intensity walking exercise (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmias).\n* Severe musculoskeletal or orthopedic conditions limiting safe participation in supported stepping (e.g., unstable fractures, severe contractures preventing positioning in the device).\n* Severe spasticity or movement disorders that would preclude safe use of the device, based on investigator judgment.\n* Severe cognitive impairment, aphasia, or behavioral disturbance that would prevent informed consent or safe participation.\n* Progressive neurological conditions (e.g., progressive neurodegenerative disease) expected to significantly worsen over the 12-week study period.\n* Current participation in another interventional trial targeting gait or lower-extremity function.\n* Any other condition that, in the opinion of the investigators, would make participation unsafe or interfere with study adherence or outcome interpretation.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot, parallel-group randomized controlled trial will evaluate the feasibility, safety, usability, and preliminary efficacy of the Rise\\&Walk InHome (RWH), a novel robotic gait training device designed for home use after stroke. Twenty adults with lower-extremity motor impairment following a first-ever stroke (3 months to 5 years post-event) will be randomized 1:1 to either (1) RWH-assisted home walking plus usual care or (2) usual care alone for 12 weeks. Participants in the intervention group will receive an in-home RWH device, complete a structured device training program, and be instructed to perform 30-minute RWH walking sessions four times per week (48 sessions total). All participants will undergo standardized outcome assessments at baseline, weeks 4, 8, and 12, including the 6-Minute Walk Test (primary outcome), 10-Meter Walk Test, daily step count via wearable activity tracker, and health-related quality of life (SF-36). Additional feasibility and usability outcomes include device use and adherence, patient satisfaction and motivation, ease of use, perceived exertion, and adverse events. Findings will inform the feasibility of in-home deployment of the RWH device and provide preliminary effect-size estimates to guide the design of a larger efficacy trial.",[27,28,29,30,31,32,33,34,35,36,37],"Stroke","Neurological Diseases or Conditions","Hemiparesis;Poststroke\u002FCVA","Gait Disorders, Neurologic","Post Stroke Fatigue","Motor Recovery","Walking Difficulty","Balance Impairment","Falls Prevention","Hemiparesis","Mobility Limitation",[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62],"in-home rehabilitation","Robotic-Assisted Gait Training","gait training device","stroke recovery","functional mobility","rehabilitation technology","remote monitoring","rehabilitation robotics","Fitbit Step Tracking","Self-Directed Gait Training","high-intensity gait training","Neurorehabilitation Research","Lower Limb Rehabilitation","Motor Function Recovery","Physical Therapy","Walking Endurance","task specific walking practice","neurological recovery","stroke rehabilitation","home exercise program","Rise&Walk InHome","daily step count","6-minute walk test","10-meter walk test","NOT_YET_RECRUITING","2026-03-06",{"date":66,"type":67},"2026-03-09","ACTUAL",{"date":69,"type":21},"2026-08",{"date":69,"type":21},{"name":72,"class":73},"Healing Innovations","OTHER",""]