Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals (bimMsKL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974750
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Université Catholique de Louvain
Information provided by (Responsible Party):
Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne

Brief Summary:
To test the capacity of healthy and chronic stroke patients to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot REAplan (R) (bimanual version).

Condition or disease Intervention/treatment Phase
Stroke Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot Not Applicable

Detailed Description:

Over 3 consecutive days, healthy individuals and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot REAplan(R).

They will practice several tasks on the robot REAplan (R) (bimanual version), requiring either movements with the affected arm (unimanual tasks) and complex, coordinated movements with both arms (bimanual tasks).

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Evaluation of bimanual motor skill learning
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: intervention
Training on the rehabilitation robot REAplan(R) to learn complex, coordinated bimanual movements
Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot
REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements




Primary Outcome Measures :
  1. bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy

  2. bi-CO, bimanual Coordination factor measured by the REAplan robot [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

  3. bi-Force, bimanual Coordination factor measured by the REAplan robot [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    bimanual forces, forces exerted in the wrong direction by each arm (Newtons)


Secondary Outcome Measures :
  1. bi-SAT on bimanual REACHING (REAplan robot) [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    bimanual Speed/Accurady Trade-off: mathematical computation of the relationship

  2. bi-Force on bimanual REACHING (REAplan robot) [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

  3. bi-CO on bimanual REACHING (REAplan robot) [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

  4. bi-smoothness on bimanual REACHING (REAplan robot) [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    Smoothness of movement : Spectral Arc Length (SPARC)

  5. bi-error on bimanual REACHING (REAplan robot) [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    Error in centimeres or degrees during bimanual reaching

  6. BBT [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    Box & Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)

  7. whole-hand GF [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)

  8. Visual Analog Scale for fatigue (VAS fatigue) [ Time Frame: change between baseline (Day 1) and after training (Day 3) ]
    Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

STROKE PATIENTS :

Inclusion Criteria:

  • having a chronic stroke (>6 months)
  • aged 18-90 years
  • with demonstrate a stroke lesion on brain imaging.

Exclusion Criteria:

  • difficulty in understanding or executing commands
  • drug/alcohol abuse
  • severe aphasia / cognitive deficits interfering with study
  • inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
  • multiple strokes / dementia / psychiatric condition
  • botulinum toxin injections (to be evaluated)

HEALTHY INDIVIDUALS :

Inclusion Criteria:

- 18-90 years

Exclusion Criteria:

  • neurological conditions interfering with the study
  • drug/alcohol abuse
  • pyschiatric condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974750


Contacts
Layout table for location contacts
Contact: Yves Vandermeeren, MD, PhD +3281423321 yves.vandermeeren@uclouvain.be

Locations
Layout table for location information
Belgium
CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Yves Vandermeeren, MD, PhD    +32 81 42 3321    yves.vandermeeren@uclouvain.be   
Sub-Investigator: Mie Leeuwerck, PT         
Sub-Investigator: Audrey Riga, MSc         
Sub-Investigator: Damien Bontemps, student         
Sub-Investigator: Nicolas-Thomas Babuin, student         
Department of Neurology, CHU Mont-Godinne Recruiting
Yvoir, Namur, Belgium
Contact: Yves Vandermeeren, MD,PhD    081 42 3321 ext +32    yves.vandermeeren@uclouvain.be   
Sponsors and Collaborators
University Hospital of Mont-Godinne
Université Catholique de Louvain
Investigators
Layout table for investigator information
Principal Investigator: Yves Y Vandermeeren, MD, PhD Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU

Publications:
Layout table for additonal information
Responsible Party: Pr Yves Vandermeeren, MD, PhD, MD, PhD, Neurologist, Principal Investigator, Clinical Professor, University Hospital of Mont-Godinne
ClinicalTrials.gov Identifier: NCT03974750     History of Changes
Other Study ID Numbers: bimMsKL
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the precise IPD plan has to be worked out in order to find the best public repository
Supporting Materials: Study Protocol
Time Frame: Up to 2 years after publication of the scientific articles
Access Criteria: none (public)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases