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    "path": "/trials/NCT04383873",
    "result": {"pageContext":{"pagePath":"/trials/NCT04383873","trial":{"nct_id":"NCT04383873","brief_title":"Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients","official_title":"Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients","about_trial":"This trial is recruiting individuals with cervical spinal cord injuries to test the use of a commercial robotic device (Armeo® Spring System) and virtual reality on activities of daily living. In particular, the study will focus on the ability to drink from a glass. Participants will receive 40 1-hour sessions of either upper limb therapy with the Armeo® device or conventional therapy without the device.","age_from":16,"age_to":75,"ais_a":true,"ais_b":true,"ais_c":true,"ais_d":true,"ais_e":false,"time_since_injury_from":0,"time_since_injury_from_unit":"days","time_since_injury_to":6,"time_since_injury_to_unit":"months","healthy_volunteers":false,"inclusion_criteria":[],"study_type":"interventional","allocation":"Randomized","brief_description":"Loss of motor function is a consequence after a spinal cord injury (SCI). The incidence of SCI varies greatly from 12.1 to 57.8 cases per million depending on the country. More than 50% of people with SCI have impaired upper limb (UL) function, experiencing limitations in performing functional tasks. In this context, one of the rehabilitation objectives is to achieve the maximum level of independence in the patient in the performance of activities of daily living (ADL).\n\nWithin the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means.\n\nThe main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.","detailed_description":"40 sessions of 1) 30 minutes of upper limb therapy with the Armeo® device plus 30 minutes of conventional therapy; or 2) 1-hour of conventional therapy without the device.","final_testing_performed":null,"version_id":7,"emsci_trial":false,"curation_status":"curated","overall_recruitment_status":"ended","primary_intervention":{"id":3,"name":"Rehabilitation","parent_id":null,"icon_name":"medical-rehabilitation"},"primary_benefit":{"id":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},"sex":"All","injury_level_from":"C1","injury_level_to":"C7","start_date":"2016-06-18","organization":"Hospital Nacional de Parapléjicos de Toledo","benefits":[{"id":1,"name":"Arm/hand function","parent_id":null,"icon_name":"hand-expand"},{"id":5,"name":"General health","parent_id":null,"icon_name":"general-health"},{"id":6,"name":"Mental health and psychosocial factors","parent_id":null,"icon_name":"mental-health"}],"injuries":[{"id":3,"name":"Traumatic","parent_id":1,"pivot":{"trial_id":2815,"injury_id":3}},{"id":6,"name":"Non-traumatic","parent_id":2,"pivot":{"trial_id":2815,"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":[],"recovery_mechanisms":[],"published_at":"2021-11-05T18:39:53.000000Z","modified_at":"2021-11-05T18:39:53.000000Z"},"layout":"trial"}},
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