Robotic devices can provide physical assistance to people who have suffered neurological impairments such as stroke. Neurological disorders related to this condition induce abnormal gait patterns, which impede the independence to execute different Activities of Daily Living (ADLs). From the fundamental role of the ankle in walking, Powered Ankle-Foot Orthoses (PAFOs) have been developed to enhance the users’ gait patterns, and hence their quality of life. Ten patients who suffered a stroke used the actuation system of the T-FLEX exoskeleton triggered by an inertial sensor on the foot tip. The VICONmotion capture system recorded the users’ kinematics for unassisted and assisted gait modalities. Biomechanical analysis and usability assessment measured the performance of the system actuation for the participants in overground walking. The biomechanical assessment exhibited changes in the lower joints’ range of motion for 70% of the subjects. Moreover, the ankle kinematics showed a correlation with the variation of other movements analyzed. This variation had positive effects on 70% of the participants in at least one joint. The Gait Deviation Index (GDI) presented significant changes for 30% of the paretic limbs and 40% of the non-paretic, where the tendency was to decrease. The spatiotemporal parameters did not show significant variations between modalities, although users’ cadence had a decrease of 70% of the volunteers. Lastly, the satisfaction with the device was positive, the comfort being the most user-selected aspect. This article presents the assessment of the T-FLEX actuation system in people who suffered a stroke. Biomechanical results show improvement in the ankle kinematics and variations in the other joints. In general terms, GDI does not exhibit significant increases, and the Movement Analysis Profile (MAP) registers alterations for the assisted gait with the device. Future works should focus on assessing the full T-FLEX orthosis in a larger sample of patients, including a stage of training.

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Abstract Background: Robotic devices can provide physical assistance to people who have suffered neurological impairments such as stroke. Neurological disorders related to this condition induce abnormal gait patterns, which harm the independence to execute different Activities of Daily Living (ADL). From the fundamental role of the ankle in walking, Active Ankle-Foot Orthoses (AAFOs) have been developed to enhance the users' gait patterns, and hence, their quality of life.Methods: Ten patients who suffered stroke used the actuation system of the T-FLEX orthosis triggered by an inertial sensor on the foot tip. The VICON motion capture system recorded the users' kinematics for unassisted and assisted gait modalities. Biomechanical analysis and usability assessment measured the performance of the system actuation for the participants in overground walking. Results: The biomechanical assessment exhibited changes in the range of motion of the lower joints for $70\%$ of the subjects. Moreover, the ankle kinematics showed a correlation with the variation of other movements analyzed. This variation had positive effects on 70\% of the participants in at least one joint. The Gait Deviation Index (GDI) presented significant changes for 30\% of the paretic limbs, where one volunteer increased this index in 14\%. The spatiotemporal parameters did not show significant variations between modalities, although users' cadence had a decrease. Lastly, the satisfaction with the device was positive, being the comfort the most users-selected aspect.Conclusions: This article presented the assessment of the T-FLEX actuation system in people who suffered stroke. Biomechanical results showed improvement in the ankle kinematic and variation in the other joints. In general terms, GDI did not exhibit significant changes, and Movement Analysis Profile (MAP) registered the main movements altered by the device. Future works should focus on assessing the full T-FLEX orthosis in a larger sample of patients that includes a stage of training.Trial registration: This study was registered as Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthosis for Stroke Survivors on 30 January 2020 in Clinical Trials with the identi er No NCT04249349 (available at https://clinicaltrials.gov/ct2/show/NCT04249349).

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