[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ABLE Human Motion S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100650193","clinical-investigation-to-validate-the-safety-and-performance-of-the-able-kids-device-in-pediatric-patients-with-neurological-gait-disorders-in-a-clinical-setting-100650193",false,"NCT07745712","Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting","Inclusion Criteria:\n\n* Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness\n* Anthropometric measurements compatible with the use of the exoskeleton, particularly:\n* Weight under 75 kg\n* Height between 1.0-1.5 m\n* Hip: maximum distance between greater trochanters of 35 cm\n* Thigh: maximum distance from trochanter to knee joint line of 36 cm\n* Lower leg: maximum distance from knee joint line to shoe sole of 45 cm\n* Medically stable\n* Intact skin in areas in contact with the device\n* Favorable medical assessment for standing, gait training, and weight-bearing activities\n* Signed informed consent from parents or legal guardians, and assent from the minor whenever possible, according to age and cognitive ability\n\nExclusion Criteria:\n\n* Severe spasticity in the lower limbs (MAS \\> 3)\n* Severe osteoporosis resulting in atraumatic bone fractures\n* Unhealed fractures or history of fragility fractures in the lower extremities within the past 2 years\n* Unstable or painful hip dislocation (MP \\> 50)\n* Symptomatic heterotopic ossification with mechanical limitation or pain\n* Anatomical limitations incompatible with proper fitting and safe use of the device:\n* Leg length discrepancy \\>1.5 cm in the upper segment or \\>2.0 cm in the lower segment\n* Severe scoliosis (Cobb angle \\>40° without the possibility of orthotic use during operation)\n* Inability to achieve proper adjustment within the device\n* Joint range of motion limitations preventing use of the exoskeleton:\n* Knee flexion contracture ≥40°\n* Hip flexion contracture ≥20°\n* Rigid equinus foot\n* Spine or lower extremity surgery within the last 3 months\n* Recently implanted pacemakers\n* Inability to communicate pain, fear, or discomfort (verbally or nonverbally)\n* Daytime mechanical ventilation\n* Uncontrolled epileptic seizures\n* Medical or cardiovascular instability\n* Considered unsuitable by physicians and physiotherapists. Any acute medical condition such as fever, infection, respiratory problems, urinary symptoms, uncontrolled pain, new swelling or redness in the extremities, active deep vein thrombosis, or severe comorbidities considered incompatible with the use of ABLE Kids until clinical resolution\n* Absence of head or trunk control in sitting or standing that cannot be compensated through the use of orthotic support during exoskeleton use","ALL","17 Years",{"count":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"NA","The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program in a clinical setting.\n\nThe secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.",[25,26,27,28,29,30,31],"Gait Impairment","Aquired Brain Injury","Cerebral Palsy (CP)","Neuromuscular Diseases (NMD)","Spinal Cord Injuries (SCI)","Spina Bifida","Muscular Weakness",[33,34,35],"gait training","wearable exoskeleton","lower-limb exoskeleton","NOT_YET_RECRUITING","2026-07-30",{"date":39,"type":40},"2026-08-04","ACTUAL",{"date":42,"type":19},"2026-09-01",{"date":44,"type":19},"2026-12-31",{"name":46,"class":47},"ABLE Human Motion S.L.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100597752","exoskeleton-training-at-home-to-assist-participants-with-spinal-cord-injuries-to-perform-ambulatory-functions-100597752","NCT07062575","Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.","Clinical Investigation on the Safety and Performance of the ABLE Daily to Assist People With Spinal Cord Injury in Performing Ambulatory Functions in Home and Community Settings","Inclusion Criteria:\n\n* At least 18 years old\n* Chronic SCI (\\>6 months)\n* Injury at levels T1 to L5 (AIS A to D)\n* Walking Index for Spinal Cord Injury (WISCI) score 0 until 9\n* Height between 150-200 cm\n* Weight less than 100 kg\n* Capable of giving informed consent on their own\n* Able to train (at least) 3 days\u002Fweek\n* Able to have at least 1 companion \u002F buddy who can attend a minimum of two of the training sessions, besides the final assessment, and who will learn how to assist them at home and in the community (ideally two companions)\n* Proficiency in walking with the ABLE Exoskeleton\n* At least 8 weeks with minimal use (less than 5 sessions) of wearable robotic exoskeletons for gait assistance at the start of the study.\n\nExclusion Criteria:\n\n* High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip, distal femur, and proximal tibia BMD score\n* Fragility fractures of the lower limbs in the last 2 years\n* Deterioration \\>3 in the International Standards for Neurological Classification of SCI (ISNCSCI) score in the last 4 weeks\n* Spinal instability, like spondylolisthesis\n* Disorders of the arms and hands that make walking with crutches impossible\n* Modified Ashworth Scale (MAS) \\>3 in lower limbs\n* Cardiovascular health issues which prevent the participant from training\n* Instability to tolerate 10 minutes of standing without clinical symptoms of orthostatic hypotension\n* Psychological, cognitive issues, or any other condition that does not allow a participant to follow study procedures\n* Medically unstable due to severe comorbidities, including any condition that a physician deems inappropriate for completing study participation\n* Skin problems in areas that would be in contact with the device\n* Height, width, weight, or other anatomical limitations (such as differences in leg length) incompatible with the device\n* Insufficient joint range of motion (ROM) for the device\n* Known pregnancy","18 Years",{"count":58,"type":19},10,[22],"The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.\n\nThe experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).",[62],"Spinal Cord Injury","RECRUITING","2026-06-01",{"date":66,"type":40},"2026-06-02",{"date":68,"type":40},"2025-06-19",{"date":70,"type":19},"2026-10-30",{"name":46,"class":47},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100595719","a-trial-on-the-clinical-and-socioeconomic-impact-of-wearable-exoskeletons-for-spinal-cord-injury-rehabilitation-in-the-spanish-healthcare-system-100595719","NCT07036107","A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System","Robotic-SNS: A Multicenter, Randomized Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System","Inclusion Criteria:\n\n* diagnosis of spinal cord injury (SCI) in the acute or subacute phase (\\\u003C 6 months of evolution)\n* traumatic or non-traumatic aetiology\n* neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B.\n* sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale).\n* range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position)\n* muscle spasticity in the lower extremities with a score ≤ 3 on the Modified Ashworth Scale (MAS)\n* tolerate bipedalism (having stood up in the last year)\n* aged between 18 and 70 years, with height between 150 cm and 190 cm, and weight less than 100 kg\n\nExclusion Criteria:\n\n* WISCI ≥ 15\n* cognitive or neurological limitations that prevent following instructions\n* another neurologic disorder permanently affecting gait and gait therapy (other than SCI)\n* grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton\n* unresolved fractures at the time of the study\n* uncontrolled autonomic dysautonomia\n* intolerance to exercise\n* uncontrolled epilepsy\n* previous experience with Robotic-Assisted Gait Training (RAGT).\n* ROM restriction such as flexing or arthrodesis will be excluded\n* spinal instability (or spinal orthotics unless cleared by a medical doctor).\n* deterioration \\>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and\u002For motor activity above the level of injury detected that has not been evaluated by a doctor.","70 Years",{"count":81,"type":19},80,[22],"This clinical trial aims to collect evidence on the clinical benefits and the socioeconomic impact of integrating a novel wearable powered lower-limb exoskeleton for gait rehabilitation in acute\u002Fsubacute spinal cord injured individuals and to evaluate the efficiency of this technology to the current standard of care in the Spanish Healthcare System (SNS).. The main questions it aims to answer are:\n\n* Is robotic therapy for gait rehabilitation more effective and efficient than conventional therapy?\n* Does robotic therapy for gait rehabilitation reduce the burden on healthcare professionals and caregivers?\n* Does robotic therapy for gait rehabilitation reduce direct healthcare costs?\n* Does robotic therapy for gait rehabilitation reduce intervention-related costs?\n\nResearchers will compare a novel wearable powered lower-limb exoskeleton for gait rehabilitation to conventional therapy to see if the robotic exoskeleton is more effective and efficient in improving clinical benefits and to assess if it reduces the burden of healthcare professionals and caregivers, as well as healthcare and intervention-related costs.\n\nParticipants will:\n\n* Be randomized on a 1:1 basis to receive rehabilitation treatment with either the robotic exoskeleton or conventional therapy for gait recovery, 3 times a week on non-consecutive days for 8 weeks (24-session program).\n* Undergo a pre- and post-intervention assessment of clinical, functional, physiological, psychological, and socioeconomic variables.\n* Have a follow-up visit 2 months after the end of the treatment.",[62],"2026-01-26",{"date":87,"type":40},"2026-01-27",{"date":89,"type":40},"2026-01-15",{"date":91,"type":19},"2027-09-30",{"name":46,"class":47},2,""]