RESULT OF CLINICAL TRIALS WITH CHILDREN WITH SPINAL MUSCULAR ATROPHY USING THE ATLAS 2020 LOWER-LIMB ACTIVE ORTHOSIS

摘要

This paper presents the outcomes, challenges and evolution of the active pediatric orthosis ATLAS 2020 throughout the clinical tests performed in the hospital Sant Joan de Deu in Barcelona (Spain) during three months of clinical trials. The test was carried out with 7 children with spinal muscular atrophy (SMA). The test evaluated the safety and performance of the exoskeleton with both psychological and physiological measures. The test was successfully passed. All children within the inclusion criteria walked more than ten meters, comfortably and safely. During the clinical trials, both psychological and technical issues were raised. In this paper, these issues are analyzed in detail. Psychologically it is necessary to prepare the children and perform several previous tests to face the fear of using the device and show them that it is safe. From a technical point of view, it was necessary to develop algorithms for the generation of synthetic trajectories to address the patient's joint limitations. In addition, strength control techniques were developed to guarantee good support while guaranteeing the safety comfort of these patients that are especially sensitive. In general, it is concluded that the development of an exoskeleton should be focused on a disease in both its mechanical design and its functionality.