The Role of MNS in Improving Motor Performance

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Lokomat

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; 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; Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The "RAGT"and "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
Active Comparator: Only RAGT; 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; Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The "RAGT"and "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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Publications and helpful links

General Publications

• Calabro RS, Naro A, Russo M, Leo A, De Luca R, Balletta T, Buda A, La Rosa G, Bramanti A, Bramanti P. The role of virtual reality in improving motor performance as revealed by EEG: a randomized clinical trial. J Neuroeng Rehabil. 2017 Jun 7;14(1):53. doi: 10.1186/s12984-017-0268-4.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 19, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 19, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 43/2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No