[{"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:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100597752","exoskeleton-training-at-home-to-assist-participants-with-spinal-cord-injuries-to-perform-ambulatory-functions-100597752",false,"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","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","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).",[26],"Spinal Cord Injury","RECRUITING","2026-06-01",{"date":30,"type":31},"2026-06-02","ACTUAL",{"date":33,"type":31},"2025-06-19",{"date":35,"type":20},"2026-10-30",{"name":37,"class":38},"ABLE Human Motion S.L.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":39},"100635285","clinical-investigation-to-validate-the-safety-and-performance-of-integrating-functional-electrical-stimulation-into-the-able-exoskeleton-100635285","NCT07550699","Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton","Inclusion Criteria:\n\n* 18 to 80 years old\n* Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis\n* Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Significant osteoporosis that may increase the risk of fracture\n* Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years\n* Spinal instability (or use of spinal orthoses, unless medically approved)\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.\n* Severe spasticity: Level 4 on the Modified Ashworth Scale\n* Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position\n* Uncontrolled autonomic dysreflexia\n* Medical instability\n* Unstable cardiovascular condition, hemodynamic instability, untreated hypertension (SBP \\> 140 mmHg, DBP \\> 90 mmHg), deep vein thrombosis (DVT), or uncontrolled autonomic dysreflexia\n* Severe comorbidities, including any condition deemed inappropriate by the investigator for using the ABLE Exoskeleton or for completing the study\n* Pressure ulcers Grade I or higher (as defined by the European Pressure Ulcer Advisory Panel - EPUAP) in areas that will be in contact with the device\n* Anthropometric measurements incompatible with the ABLE Exoskeleton, specifically height outside the 1.5-1.9 m range or weight exceeding 100 kg\n* Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device\n* Range of motion restrictions preventing normal gait or sit-to-stand transitions, including: Ankle: ability to achieve at least neutral (0°) position; Knee: ability to extend to at least -10°; Hip: bilateral hip flexion of at least 100° and extension of at least 0°\n* Heterotopic ossification\n* Pregnant or breastfeeding women\n* Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures\n* Requires assisted ventilation.\n* Scoliosis \\>40-50º Cobb angle.\n* Presence of pacemakers, defibrillators, or other non-compatible electronic implants.\n* Open wounds, infections, or active irritation at the electrode placement sites.\n* Severe dermatological conditions in the stimulation area.\n* Uncontrolled active epilepsy.\n* Malignant tumors in the area of application.\n* Severe loss of sensation in the areas where electrodes are to be placed.\n* Medical conditions where electrical stimulation is contraindicated by physician recommendation.\n* Inability to communicate pain, discomfort, or adverse reactions during stimulation.\n* Venous thrombosis, thrombophlebitis, or severe arterial obstruction.\n* Chronic venous insufficiency with significant varicosities.\n* Hemophilia.\n* Ongoing infectious process or fever.\n* Presence of metallic implants in the flow area between the electrodes","80 Years",{"count":48,"type":20},15,[23],"The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis.\n\nThe secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.",[52,26,53],"Acquired Brain Injury (Including Stroke)","Multiple Sclerosis",[55,56,57,58,26,53,59,60,61],"Gait training","Wearable exoskeleton","Acquired Brain Injury","Lower-limb exoskeleton","Functional Electrical Stimulation (FES)","Robotic exoskeleton","Hybrid exoskeleton-FES system","2026-04-22",{"date":64,"type":31},"2026-04-24",{"date":66,"type":31},"2026-04-20",{"date":68,"type":20},"2026-08-12",{"name":37,"class":38},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"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":79,"type":20},80,[23],"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.",[26],"2026-01-26",{"date":85,"type":31},"2026-01-27",{"date":87,"type":31},"2026-01-15",{"date":89,"type":20},"2027-09-30",{"name":37,"class":38},2,""]