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

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yves Vandermeeren, MD, PhD; Phone Number: +3281423321; Email: yves.vandermeeren@uclouvain.be

Study Locations

• Belgium
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Recruiting
      • CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
      • Contact: Yves Vandermeeren, MD, PhD; Phone Number: +32 81 42 3321; Email: yves.vandermeeren@uclouvain.be
      • Contact: Mie Leeuwerck, PT
      • Contact: Audrey Riga, MSc
      • Contact: Damien Bontemps, student
      • Contact: Nicolas-Thomas Babuin, student
    • Yvoir, Namur, Belgium
      • Recruiting
      • Department of Neurology, CHU Mont-Godinne
      • Contact: Yves Vandermeeren, MD,PhD; Phone Number: +32 081 42 3321; Email: yves.vandermeeren@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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
Active Comparator: control intervention; Training on the rehabilitation robot REAplan(R) with simple movements	Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot; REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot	bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy	change between baseline (Day 1) and after training (Day 3)
bi-CO, bimanual Coordination factor measured by the REAplan robot	bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms	change between baseline (Day 1) and after training (Day 3)
bi-Force, bimanual Coordination factor measured by the REAplan robot	bimanual forces, forces exerted in the wrong direction by each arm (Newtons)	change between baseline (Day 1) and after training (Day 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bi-SAT on bimanual REACHING (REAplan robot)	bimanual Speed/Accurady Trade-off: mathematical computation of the relationship	change between baseline (Day 1) and after training (Day 3)
bi-Force on bimanual REACHING (REAplan robot)	bimanual forces, forces exerted in the wrong direction by each arm (Newtons)	change between baseline (Day 1) and after training (Day 3)
bi-CO on bimanual REACHING (REAplan robot)	bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms	change between baseline (Day 1) and after training (Day 3)
bi-smoothness on bimanual REACHING (REAplan robot)	Smoothness of movement : Spectral Arc Length (SPARC)	change between baseline (Day 1) and after training (Day 3)
bi-error on bimanual REACHING (REAplan robot)	Error in centimeres or degrees during bimanual reaching	change between baseline (Day 1) and after training (Day 3)
BBT	Box & Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)	change between baseline (Day 1) and after training (Day 3)
whole-hand GF	whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)	change between baseline (Day 1) and after training (Day 3)
Visual Analog Scale for fatigue (VAS fatigue)	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.	change between baseline (Day 1) and after training (Day 3)

Collaborators and Investigators

• Sponsor: University Hospital of Mont-Godinne
• Collaborators: Université Catholique de Louvain
• Investigators: Principal Investigator: Yves Y Vandermeeren, MD, PhD, Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU

Publications and helpful links

General 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.
• Gerardin E, Bontemps D, Babuin NT, Herman B, Denis A, Bihin B, Regnier M, Leeuwerck M, Deltombe T, Riga A, Vandermeeren Y. Bimanual motor skill learning with robotics in chronic stroke: comparison between minimally impaired and moderately impaired patients, and healthy individuals. J Neuroeng Rehabil. 2022 Mar 17;19(1):28. doi: 10.1186/s12984-022-01009-3.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: bimMsKL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the precise IPD plan has to be worked out in order to find the best public repository
• IPD Sharing Time Frame: Up to 2 years after publication of the scientific articles
• IPD Sharing Access Criteria: none (public)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No