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    "path": "/trials/NCT04453943",
    "result": {"pageContext":{"pagePath":"/trials/NCT04453943","trial":{"nct_id":"NCT04453943","brief_title":"Modeling, Optimization, and Control Methods for a Personalized Hybrid Walking Exoskeleton","official_title":"Modeling, Optimization, and Control Methods for a Personalized Hybrid Walking Exoskeleton","about_trial":"This trial is recruiting individuals with chronic, thoracic-level (chest area) spinal cord injuries to validate computer programming sequences (algorithms) that coordinate functional electrical stimulation (FES) and exoskeleton use during walking and during transitions from standing to sitting. FES applies electrical stimulation through the skin to nerves/muscles to cause contraction of weakened or paralyzed muscles. An exoskeleton is an externally worn battery-powered robotic device to assist movement. Participants will undergo 1) exoskeleton-assisted walking movements with or without FES; and 2) exoskeleton-assisted sit-to-stand movements with or without FES. Final testing will be performed after 30 months.","age_from":18,"age_to":60,"ais_a":true,"ais_b":true,"ais_c":true,"ais_d":true,"ais_e":false,"time_since_injury_from":1,"time_since_injury_from_unit":"years","time_since_injury_to":60,"time_since_injury_to_unit":"years","healthy_volunteers":true,"inclusion_criteria":[],"study_type":"interventional","allocation":"Non-Randomized","brief_description":"The central objective of this study is to validate new algorithms that coordinate between functional electrical stimulation (FES) and the exoskeleton during sitting-to-standing, walking, and standing-to-sitting movements. The secondary objective is to optimize the algorithms as well as assess their ability to reduce FES-induced muscle fatigue by using ultrasound imaging as a sensing modality. This study will include persons with no disabilities and persons with Spinal Cord Injury (SCI). A research set-up comprising of a lower-limb exoskeleton and FES system will be used to achieve sitting-to-standing, walking, and standing-to-sitting movements. Ultrasound Imaging probes may be used to record muscle activity of the stimulated muscles. The signals derived from ultrasound will be used to optimize FES in order to reduce muscle fatigue as well as assess muscle fatigue.","detailed_description":"The participant will undergo 1) exoskeleton-assisted walking movements with or without FES and 2) exoskeleton-assisted sit-to-stand movements with or without FES.\nFinal testing will be performed after 30 months.","final_testing_performed":null,"version_id":7,"emsci_trial":false,"curation_status":"curated","overall_recruitment_status":null,"primary_intervention":{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},"primary_benefit":{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"},"sex":"All","injury_level_from":"T1","injury_level_to":"T10","start_date":"2020-07-01","organization":"North Carolina State University","benefits":[{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":2818,"injury_id":3}}],"interventions":[{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"},{"id":6,"name":"Psychosocial/other","parent_id":null,"icon_name":"alternative-or-complimentary"}],"outcome_measures":[],"recovery_mechanisms":[],"published_at":"2021-11-05T18:45:50.000000Z","modified_at":"2021-11-05T18:45:50.000000Z"},"layout":"trial"}},
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