The Role of MNS in Improving Motor Performance

Study Overview
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Brief Summary
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Many studies have demonstrated the usefulness of repetitive task practice by using robotic devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized clinical trial aimed at evaluating the correlation between the modifications of brain oscillations during a VR neurorehabilitative training of gait and the motor function recovery in patients with chronic stroke. Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR) whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical, kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG) were measured before and after the robotic intervention. The robotic-based rehabilitation combined with VR could be associated with improvements in several measurements of lower limb function, gait, and balance in patient with chronic hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor performance and to develop non-invasive brain-computer interfaces controlling robotic devices.

Official Title
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The Role of Mirror Neuron System in Improving Motor Performance by Using Virtual Reality, as Revealed by EEG: a Randomized Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Lokomat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥55 years A first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment; An unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3 Ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) >24 A mild to moderate spasticity according to a Modified Ashworth Scale (MAS) ≤2 No severe bone or joint disease No history of concomitant neurodegenerative diseases or brain surgery. Exclusion Criteria: Severe cognitive and behavioral impairments Severe osteoporosis and previous bone fractures

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>This group performed 40 45-min Lokomat sessions, five times a week, by using a visual feedback showing a Virtual Reality run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. | Device: Lokomat<br>* Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The RAGTand VR group received a visual feedback showing a VR run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. Each avatar's leg movement corresponded to that performed by the patient. On the other hand, the RAGT without VR group was not provided an avatar, and a smile indicating the goodness of each leg movement. The biofeedback of the Lokomat gait orthosis is based on the interaction torques between the participant and the orthosis<br>|
| Active Comparator: Only RAGT<br>This groups performed 40 Lokomat sessions (40-45min), five times a week, between 9am and 11am, in this case was not provided an avatar, and a smile indicating the goodness of each leg movement. | Device: Lokomat<br>* Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The RAGTand VR group received a visual feedback showing a VR run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. Each avatar's leg movement corresponded to that performed by the patient. On the other hand, the RAGT without VR group was not provided an avatar, and a smile indicating the goodness of each leg movement. The biofeedback of the Lokomat gait orthosis is based on the interaction torques between the participant and the orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait evaluated by Rivermead Mobility Index (RMI) |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity evaluated by Modified Ashworth Scale (MAS) |  | Six months |