The Role of MNS in Improving Motor Performance

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Completed

Conditions: Stroke

Treatments: Device: Lokomat

Study type: Interventional

Funder types: Other

Identifiers

NCT02971371

43/2013

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Virtual Reality

Experimental group

Description:

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.

Treatment:

Device: Lokomat

Only RAGT

Active Comparator group

Description:

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.

Treatment:

Device: Lokomat