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| Name | Class |
|---|---|
| Biomedical Robotics and Biomicrosystems, Campus Bio-Medico University | UNKNOWN |
| Physical and Rehabilitation Medicine, Campus Bio-Medico University | UNKNOWN |
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Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic therapy and real tVNS | Experimental | This group receives REAL vagus nerve stimulation during robotic rehabilitation. |
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| Robotic therapy and sham tVNS | Active Comparator | This group receives SHAM VNS during robotic rehabilitation. Sham VNS is not effective. Both groups receive the same amount of robotic rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous vagal nerve stimulation | Device | The stimulation of the auricular branch of the vagus nerve will be performed through an electric stimulator and two Ag-AgCl electrodes placed in the left external acoustic meatus at the inner side of the tragus. For sham stimulation, electrodes will be attached to the left ear lobe. tVNS will be delivered as trains lasting 30 s and composed by 600 pulses (intra-train pulse frequency = 20 Hz; pulse duration = 0.3 ms) repeated every 5 min for 60 min. The intensity of stimulation will individually adjusted to a level ranging above the detection threshold and below the pain threshold. In this range, when possible, the investigators will chose an intensity of 8 mA. Each day, for 10 consecutive working days, each patient will receive a session of robotic therapy during the real or sham tVNS stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Score | immediately, one months and three months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in kinematic data (Motion Accuracy) measured by the robot | immediately, one months and three months after the intervention | |
| Change in kinematic data (Motion Direction) measured by the robot | immediately, one months and three months after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Neurology, Campus Biomedico University | Recruiting | Rome | 00128 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change in kinematic data (Smoothness) measured by the robot | immediately, one months and three months after the intervention |
| Change in kinematic data (Speed) measured by the robot | immediately, one months and three months after the intervention |
| Change in kinematic data (Movement Duration) measured by the robot | immediately, one months and three months after the intervention |
| Change in kinematic data (Efficiency) measured by the robot | immediately, one months and three months after the intervention |
| Incidence of adverse events that are related to treatment | intervention period of 10 consecutive working days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |