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出境医 / 临床实验 / Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals (bimMsKL)

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

Study Description
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, ...).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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)
  • 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.
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 Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
Official Title  ICMJE Bimanual Motor Skill Learning Through Robotics in Stroke Survivors and Healthy Individuals
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).
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, ...).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Evaluation of bimanual motor skill learning
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Stroke
Intervention  ICMJE Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot
REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements
Study Arms  ICMJE Experimental: intervention
Training on the rehabilitation robot REAplan(R) to learn complex, coordinated bimanual movements
Intervention: Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot
Publications *
  • Yeganeh Doost M, Orban de Xivry JJ, Bihin B, Vandermeeren Y. Two Processes in Early Bimanual Motor Skill Learning. Front Hum Neurosci. 2017 Dec 20;11:618. doi: 10.3389/fnhum.2017.00618. eCollection 2017.
  • Doost MY, Orban de Xivry JJ, Herman B, Vanthournhout L, Riga A, Bihin B, Jamart J, Laloux P, Raymackers JM, Vandermeeren Y. Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Jun;33(6):486-498. doi: 10.1177/1545968319847963. Epub 2019 May 15.
  • Dehem S, Gilliaux M, Lejeune T, Delaunois E, Mbonda P, Vandermeeren Y, Detrembleur C, Stoquart G. Effectiveness of a single session of dual-transcranial direct current stimulation in combination with upper limb robotic-assisted rehabilitation in chronic stroke patients: a randomized, double-blind, cross-over study. Int J Rehabil Res. 2018 Jun;41(2):138-145. doi: 10.1097/MRR.0000000000000274.
  • Yeganeh Doost M, Herman B, Denis A, Sapin J, Galinski D, Riga A, Laloux P, Bihin B, Vandermeeren Y. Bimanual motor skill learning and robotic assistance for chronic hemiparetic stroke: a randomized controlled trial. Neural Regen Res. 2021 Aug;16(8):1566-1573. doi: 10.4103/1673-5374.301030.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yves Vandermeeren, MD, PhD +3281423321 yves.vandermeeren@uclouvain.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974750
Other Study ID Numbers  ICMJE bimMsKL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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)
Responsible Party Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
Study Sponsor  ICMJE University Hospital of Mont-Godinne
Collaborators  ICMJE Université Catholique de Louvain
Investigators  ICMJE
Principal Investigator: Yves Y Vandermeeren, MD, PhD Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU
PRS Account University Hospital of Mont-Godinne
Verification Date July 2020

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

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