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The Role of MNS in Improving Motor Performance

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ClinicalTrials.gov Identifier: NCT02971371
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Rocco Salvatore Calabrò, 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.


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

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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

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




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 ]


Information from the National Library of Medicine

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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016