Use of neuromodulation system and assistive devices for rehabilitation of upper limb motor function after stroke

INTERVENTION: The protocol of the study comprises of three phases. Phase 1 Technical feasibility and usability verification: This phase includes experimentation with healthy volunteers and with a small cohort of subjects with a stroke. The intervention at this stage relies on the execution of a predefined number of a functional upper limb tasks (e.g. reaching and/or grasping) led by the assisted devices (FES and/or robots). Healthy subjects participate in a single evaluation session, while stroke subjects participate in a few evaluation sessions (no more than three). The duration of each session of either group (healthy or stroke patients) is less than 1 hour. Phase 2 Verification of cortical changes: This stage also includes healthy participants and a small cohort of subjects with stroke. In this phase, the participants carry out a predefined number of a functional upper limb tasks (e.g. reaching and/or grasping) in which a brain‐computer interfaces (BCI) trigger the action of assistive devices (FES and/or robots). Again, healthy subjects participate in a single evaluation session, while stroke subjects participate in a few evaluation sessions (no more than three). The maximum duration of each session for either group (healthy or stroke patients) is 1 hour. Phase 3 Pre‐clinical evaluation: This phase includes a multi‐session pilot intervention with one experimental and one control group. For this intervention, only subjects who has suffered a stroke are recruited. Both groups participate in 12 consecutive sessions, distributed 3 sessions per week. Participants are randomly allocated to the experimental or to the control group. Experimental group: BCI and assistive devices (FES and/or robots) are used to assist the execution of upper limb tasks. On each session, the participants are asked to perform a functional upper limb tasks (e.g. reaching and/or grasping) in which a BCI trigger the action of assistive devices (FES and/or robots). At least 50 repetitions must be accompli CONDITION: Stroke ; Circulatory System ; Stroke INCLUSION CRITERIA: Inclusion criteria for Healthy subjects: 1. Age between 18 and 65 2. Not pregnant 4. Tolerance to functional electrical stimulation of the upper limbs muscle 5. Absence of neurological lesion 6. Availability to participate to the study Inclusion criteria for subjects with stroke: 1. Aged between 18 and 65 years old 2. Not pregnant 3. Subject with a chronic or subacute stroke 4. Without prior neurological lesion to stroke 5. With cognitive capabilities to follow instruction 6. Tolerance to functional electrical stimulation of the upper limbs muscle 7. With motor response to functional electrical stimulation 8. Availability to participate to the study PRIMARY OUTCOME: Phase 1:; Arm joints kinematics are measured using kinematic sensors at sessions one, two and three (healthy volunteers only attend session one and are therefore only assessed at session one).; ; Phase 2:; 1. Arm joints kinematics are measured using kinematic sensors at sessions one, two and three (healthy volunteers only attend session one and are therefore only assessed at session one); 2. Motor evoked potential (MEP) induced by Transcranial magnetic stimulation is measured using the Electromyography (EMG) signal of the arm's muscles both before and after intervention at sessions one, two and three (healthy volunteers only attend session one and are therefore only assessed at session one); ; Phase 3:; 1. Arm joints kinematics are measured using kinematic sensors at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12; 2. Kinetics data of the arm joints under isometric condition are measured using torque sensors at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12; 3. Co‐contraction index of target muscles of the arm are measured using EMG signals at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12; 4. Clinical outcomes are measured using the Box and block test, the Modified Answorth scale for the upper limbs and the Medical Research Council scale for upper limbs at baseline (before session one) and after the intervention (after session 12) SECONDARY OUTCOME: Phase 1:; User satisfaction is measured using the Quebec User Evaluation of satisfaction with Assistive Technology 2.0 (QUEST) and Self‐Assessment Manikin (SAM) at the end of the intervention (after session three).Healthy volunteers only attend session one and are therefore only assessed at the end of the session one.; ; Phase 2:; 1. User satisfaction is measured using the Quebec User Evaluation of satisfaction with Assistive Technology 2.0 (QUEST) and Self‐Assessment Manikin (SAM) at the end of the intervention (after session three). Healthy volunteers only attend session one and are therefore only assessed at the end of the session one.; 2. Analysis of cortical pattern is measured using the recorded EEG signals at sessions one, two and three. Healthy volunteers only attend session one and are therefore only assessed at session one.; ; Phase 3:; 1. User satisfaction is measured using the Quebec User Evaluation of satisfaction with Assistive Technology 2.0 (QUEST) and Self‐Assessment Manikin (SAM) at the end of the intervention (after session 12) ; 2. Cognitive tests are assessed using the Mini‐Mental State Examination at baseline, session (before session one) and at the end of the intervention (after session 12); 3. Analysis of cortical pattern is assessed using the recorded EEG signals at session one, two, three, four, five, six, seven, eight, nine, ten, 11, and 12