Development and Upgrade of a Robot That Enables Three-Dimensional Trunk Motion and Lower Limb Exercise for Stroke Patients: A Pilot Clinical Investigation Including a User Feasibility Test.
Stroke impairs functional independence including gait ability. While robot-aided rehabilitation techniques have been developed, there is a need for a robotic system that promotes three-dimensional (3D) movement of the trunk and gait ability while providing automatic function evaluation and individually optimized prescriptions for stroke patients.
To assess the efficacy and safety of a novel trunk and lower limb robotic system for patients with hemiplegia due to chronic stroke.
This study employed a single-arm, before-after trial design conducted in an institutional setting. Twenty individuals (eight males; mean age, 52.3 ± 11.8 years) with hemiplegia resulting from chronic stroke (≥ 12 months postonset) who showed no change in the Functional Ambulation Category (FAC) for at least 2 months prior to baseline were enrolled. Participants underwent robot-assisted training using a system composed of trunk, upright, and lower extremity modules. Each participant received 30-min sessions, 5 days per week, for 4 weeks. The robotic system provided real-time kinematic motion data to support rehabilitation exercises. Primary outcomes included changes in functional evaluation and performance scores from baseline to postintervention. Additionally, a feasibility survey was administered to assess user satisfaction and identify areas for system improvement.
In all patients, the functional scores did not differ significantly between baseline and 1 month after the robotic intervention. However, there were improvements in the performance scores of lateral and forward bending of the trunk while sitting, forward bending ability during sit-to-stand activity, weight transfer, and lateral and forward bending of the trunk while standing 1 month after the intervention (p < 0.05). The user experience survey showed satisfaction in 16 of 20 patients due to the easy and safe operation of the robot.
The proposed robotic system was safe and convenient to use and was associated with improvements in selected kinematic parameters.
To assess the efficacy and safety of a novel trunk and lower limb robotic system for patients with hemiplegia due to chronic stroke.
This study employed a single-arm, before-after trial design conducted in an institutional setting. Twenty individuals (eight males; mean age, 52.3 ± 11.8 years) with hemiplegia resulting from chronic stroke (≥ 12 months postonset) who showed no change in the Functional Ambulation Category (FAC) for at least 2 months prior to baseline were enrolled. Participants underwent robot-assisted training using a system composed of trunk, upright, and lower extremity modules. Each participant received 30-min sessions, 5 days per week, for 4 weeks. The robotic system provided real-time kinematic motion data to support rehabilitation exercises. Primary outcomes included changes in functional evaluation and performance scores from baseline to postintervention. Additionally, a feasibility survey was administered to assess user satisfaction and identify areas for system improvement.
In all patients, the functional scores did not differ significantly between baseline and 1 month after the robotic intervention. However, there were improvements in the performance scores of lateral and forward bending of the trunk while sitting, forward bending ability during sit-to-stand activity, weight transfer, and lateral and forward bending of the trunk while standing 1 month after the intervention (p < 0.05). The user experience survey showed satisfaction in 16 of 20 patients due to the easy and safe operation of the robot.
The proposed robotic system was safe and convenient to use and was associated with improvements in selected kinematic parameters.