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    "result": {"pageContext":{"pagePath":"/trials/NCT07461259","trial":{"nct_id":"NCT07461259","brief_title":"Safety and Feasibility of TWIICE Rise - Phase 2","official_title":"Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury","about_trial":"The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.\n\nThis study is done in two phases:\n\nThe first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment).","age_from":18,"age_to":70,"ais_a":false,"ais_b":false,"ais_c":false,"ais_d":false,"ais_e":false,"time_since_injury_from":6,"time_since_injury_from_unit":"months","time_since_injury_to":null,"time_since_injury_to_unit":null,"healthy_volunteers":false,"inclusion_criteria":["NOT have a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events"],"study_type":"interventional","allocation":"N/A","brief_description":"The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.\n\nThis study is done in two phases:\n\nThe first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment).","detailed_description":"The aim of this clinical trial is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton assisted ambulation in patients with a spinal cord injury. The study is thus done in two phases.\n\nThe first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with five patients over 6 sessions in clinic. This phase allows the manufacturer to collect data that can be used to improve the device design if necessary.\n\nThe second phase of the study is being conducted with TWIICE Rise 1.0. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment) to test the device intended use. The first sessions are done at the rehabilitation specialized center to benefit from the clinical settings to learn to walk with the exoskeleton. Once the patients reach sufficient ambulatory skills determined by the Mobility SkillsTests, the following sessions can be done at home and community settings.","final_testing_performed":"16 weeks","version_id":2,"emsci_trial":false,"curation_status":"uncurated","overall_recruitment_status":"recruiting","primary_intervention":{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},"primary_benefit":{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},"sex":"All","injury_level_from":"C5","injury_level_to":"L5","start_date":"2023-07-25","organization":"TWIICE","benefits":[{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":7,"name":"Pain","parent_id":null,"icon_name":"pain-relief"},{"id":12,"name":"Standing/walking/mobility","parent_id":null,"icon_name":"walking"}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":7915,"injury_id":3}},{"id":6,"name":"Non-traumatic","parent_id":2,"pivot":{"trial_id":7915,"injury_id":6}}],"interventions":[{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},{"id":5,"name":"Technology","parent_id":null,"icon_name":"technology"}],"outcome_measures":[{"id":1,"name":"10 Meter Walking Test (10 MWT)","short_name":"10 MWT","pivot":{"trial_id":7915,"outcome_measure_id":1}},{"id":3,"name":"6-Minute Walk Test (6MWT)","short_name":"6MWT","pivot":{"trial_id":7915,"outcome_measure_id":3}},{"id":174,"name":"Adverse Events (AEs)","short_name":"AEs","pivot":{"trial_id":7915,"outcome_measure_id":174}},{"id":191,"name":"Blood Pressure and Heart Rate Regulation","short_name":null,"pivot":{"trial_id":7915,"outcome_measure_id":191}},{"id":94,"name":"Numeric Pain Rating Scale","short_name":null,"pivot":{"trial_id":7915,"outcome_measure_id":94}},{"id":153,"name":"Timed Up and Go Test (TUG)","short_name":"TUG","pivot":{"trial_id":7915,"outcome_measure_id":153}}],"recovery_mechanisms":[],"published_at":"2026-03-30T09:03:54.000000Z","modified_at":"2026-03-30T09:03:54.000000Z"},"layout":"trial"}},
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