The Role of MNS in Improving Motor Performance

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971371
• Other study ID #: 43/2013
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 19, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2016
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Local Ethics Committe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait evaluated by Rivermead Mobility Index (RMI)		Six months	Yes
Secondary	Spasticity evaluated by Modified Ashworth Scale (MAS)		Six months	Yes