RoboSTROKEEffect of Robot Assisted Treatment on Gait Performace in Stroke Patients

Objective: to assess the lower limb recovery after the gait rehabilitation training exercises in acute and chronic stroke patients. The proposed project, through a Randomized controlled observer-blind trial aimed at evaluating the effectiveness of end-effector robot assisted therapy vs the treadmill and ground treatment in sub-acute and chronic stroke subjects. 90 inpatients and out-patients with a stroke will be recruited. We will randomize the patients on 3 groups [15 sub-acute (ischemic and hemorrhagic) stroke patients (after 30±7 days from injury) and 15 chronic (ischemic and hemorrhagic) patients (after 3/6 months days from injury) for all groups]: sub-acute and chronic stroke patients robot treatment. sub-acute and chronic patients treadmill treatment. sub-acute and chronic patients ground treatment. The specific aims of this project are: to verify whether the robotics end-effector GEO lower limb treatment with body weight support is more effective than the treadmill treatment or ground treatment in the reduction of motor impairment in sub-acute and Chronic stroke patients, and to improve the quality of the gait and the endurance; to analyse possible improvements in terms of physiological biomechanical gait through analysis of kinematics , kinetics and EMG evaluation; to analyse possible improvements in terms of reduction of instable posture and movements, which can represent a reduction of the risk of fall typical of these subjects; to evaluate the kinematic, kinetic and EMG quantitative data during selected movements (gait, posture, ) compared with age matched reference data; to investigate the stability of the effects of robot-assisted treatment at 4/6 months follow-up in terms of Quality of Life (QoL). A first goal of this project is to investigate the differences in improvement of the quality and safety of the gait (motor performance and functional recovery) through kinematic/kinetic and EMG parameters (Change in Step Length, Change in Gait Velocity and Change in Stride Time Variability, 3D joints kinematics, ground reaction forces, joint kinetics, muscle activation,) and traditional clinical scales in sub-acute and chronic stroke patients. The second goals is aimed at identifying possible advantages in the QoL of patients undergoing such a kind of in-patients and out-patients rehabilitation treatment and at investigating novel methods enabling lower limb functional recovery, leading to wide potential for regaining personal independence. The third goal is to analyse direct cost savings associated with the use of such technologies, measured as direct, indirect and intangible costs, through specific HTA procedures.