[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aquired-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aquired-brain-injury":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":56,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":20,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100582728","effectiveness-of-a-customized-digital-platform-to-increase-coordination-of-care-and-uptake-of-evidence-based-practices-100582728","NCT06867081","Effectiveness of a Customized Digital Platform to Increase Coordination of Care and Uptake of Evidence-based Practices","Effectiveness of a Customized Digital Platform to Increase Coordination of Care and Uptake of Evidence-based Practices: a Protocol for a Stepped-wedge Cluster Randomized Trial in Quebec","Inclusion Criteria:\n\nClinicians, coordinators, managers, working in the 8 participating programs.\n\nPatients and caregivers must be able to:\n\n* Provide informed consent to collect secondary outcomes (not needed for primary outcome, as identified administrative data will be provided by health regions)\n* Speak and read English or French.\n\nExclusion Criteria:\n\n* N\u002FA",true,"18 Years",{"count":59,"type":19},962,[22],"Background: Cardiovascular and neurological conditions are major causes of disability worldwide. Early, intensive rehabilitation is essential but often challenging to access in current healthcare systems. In Canada, the direct and indirect costs of acquired brain injury (ABI) are substantial, emphasizing the need for improved rehabilitation services. In collaboration with four health regions and the Canadian Foundation of Innovation (CFI) funded BRILLIANT research group, investigators are implementing a digital health platform (the BRILLIANT platform), which includes five modules to address current gaps and support a person-centered integrated care continuum for cardiovascular and neurological conditions. In this stepped wedge randomized trial, investigators plan to implement and evaluate the use of the BRILLIANT Platform for improving transitions of care in the rehabilitation of ABI individuals in Quebec.\n\nMethods: A stepped wedge cluster randomized trial will be conducted across four healthcare regions with eight programs. Eligible participants included new cardiovascular and neurological patients, caregivers, clinicians, coordinators, and managers. The BRILLIANT platform intervention, implemented in 2 phases, will provide standardized assessments, communication tools, shared intervention plans, self-management support, and quality improvement dashboards. Outcomes will include rehabilitation intensity measured in minutes, time from admission to rehabilitation, health-related quality of life, care experience, and costs. Data analysis will use mixed-effects models for quantitative data and content analysis for qualitative data.\n\nDiscussion: This study will provide valuable evidence on the effectiveness and feasibility of the BRILLIANT platform in improving rehabilitation care for patients with cardiovascular and neurological conditions in Quebec. Investigators anticipate that by addressing the challenges and pursuing future directions, the implementation of this digital platform can contribute to improving patient outcomes and healthcare delivery.",[26,63,64,65],"Traumatic Brain Injuries","Stroke","Cardiovascular Diseases",[67,68,69,70,71,72,73],"Acquired brain injury","Digital health platform","Rehabilitation","Transition of care","Person-centered care","Implementation science","stepped wedge trial","2025-08-22",{"date":76,"type":40},"2025-08-28",{"date":78,"type":19},"2025-09-30",{"date":80,"type":19},"2029-12",{"name":82,"class":83},"Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal","OTHER"]