The Role of MNS in Improving Motor Performance

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Lokomat

• Registration Number: NCT02971371
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-19
• Last Update Submitted: 2016-11-19
• Study First Posted: 2016-11-22
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Lokomat	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.
Only RAGT	Lokomat	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.

Primary Outcome Measures

Name	Time	Method
gait evaluated by Rivermead Mobility Index (RMI)	Six months

Secondary Outcome Measures

Name	Time	Method
Spasticity evaluated by Modified Ashworth Scale (MAS)	Six months