The Role of MNS in Improving Motor Performance

• ClinicalTrials.gov Identifier: NCT02971371
• Recruitment Status: Completed
• First Posted: November 22, 2016
• Last Update Posted: November 22, 2016
• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Information provided by (Responsible Party): Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: Lokomat	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Role of Mirror Neuron System in Improving Motor Performance by Using Virtual Reality, as Revealed by EEG: a Randomized Clinical Trial
• Study Start Date: October 2015
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. gait evaluated by Rivermead Mobility Index (RMI) [ Time Frame: Six months ]

Secondary Outcome Measures :

1. Spasticity evaluated by Modified Ashworth Scale (MAS) [ Time Frame: Six months ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Calabrò 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.

• Responsible Party: Rocco Salvatore Calabrò, Principal investigator, IRCCS Centro Neurolesi "Bonino-Pulejo"
• ClinicalTrials.gov Identifier: NCT02971371
• Other Study ID Numbers: 43/2013
• First Posted: November 22, 2016
• Last Update Posted: November 22, 2016
• Last Verified: November 2016