Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of MNS in Improving Motor Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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"

Tracking Information
First Submitted Date  ICMJE November 7, 2016
First Posted Date  ICMJE November 22, 2016
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2016)
gait evaluated by Rivermead Mobility Index (RMI) [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2016)
Spasticity evaluated by Modified Ashworth Scale (MAS) [ Time Frame: Six months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of MNS in Improving Motor Performance
Official Title  ICMJE The Role of Mirror Neuron System in Improving Motor Performance by Using Virtual Reality, as Revealed by EEG: a Randomized Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Stroke
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Lokomat
  • 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.
    Intervention: Device: Lokomat
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02971371
Other Study ID Numbers  ICMJE 43/2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rocco Salvatore Calabrò, IRCCS Centro Neurolesi "Bonino-Pulejo"
Original Responsible Party Same as current
Current Study Sponsor  ICMJE IRCCS Centro Neurolesi "Bonino-Pulejo"
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IRCCS Centro Neurolesi "Bonino-Pulejo"
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP