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RecruitingNCT03974750bimMsKLUpdated Apr 3, 2025

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

An interventional study of Bimanual motor skill learning with the REAplan(R) rehabilitation robot in Stroke, sponsored by University Hospital of Mont-Godinne. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by University Hospital of Mont-Godinne · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jul 2017, registered May 2019).
  • Started Jul 2017; still recruiting 9 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

Read the 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, ...).

02

Conditions studied

  • Stroke

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03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 100 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital of Mont-Godinne is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceBimanual motor skill learning with the REAplan(R) rehabilitation robot

    REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: change between baseline (Day 1) and after training (Day 3)

  2. bi-CO, bimanual Coordination factor measured by the REAplan robot

    bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

    Time frame: change between baseline (Day 1) and after training (Day 3)

  3. bi-Force, bimanual Coordination factor measured by the REAplan robot

    bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

    Time frame: change between baseline (Day 1) and after training (Day 3)

Secondary outcomes

  1. bi-SAT on bimanual REACHING (REAplan robot)

    bimanual Speed/Accurady Trade-off: mathematical computation of the relationship

    Time frame: change between baseline (Day 1) and after training (Day 3)

  2. bi-Force on bimanual REACHING (REAplan robot)

    bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

    Time frame: change between baseline (Day 1) and after training (Day 3)

  3. bi-CO on bimanual REACHING (REAplan robot)

    bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

    Time frame: change between baseline (Day 1) and after training (Day 3)

  4. bi-smoothness on bimanual REACHING (REAplan robot)

    Smoothness of movement : Spectral Arc Length (SPARC)

    Time frame: change between baseline (Day 1) and after training (Day 3)

  5. bi-error on bimanual REACHING (REAplan robot)

    Error in centimeres or degrees during bimanual reaching

    Time frame: change between baseline (Day 1) and after training (Day 3)

  6. BBT

    Box \& Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)

    Time frame: change between baseline (Day 1) and after training (Day 3)

  7. whole-hand GF

    whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)

    Time frame: change between baseline (Day 1) and after training (Day 3)

  8. 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.

    Time frame: change between baseline (Day 1) and after training (Day 3)

07

Study locations

2 of 2 sites recruiting
  • CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit
    Yvoir, Namur 5530, Belgium
    Recruiting
    • Yves Vandermeeren, MD, PhD · Contactyves.vandermeeren@uclouvain.be · +32 81 42 3321
    • Mie Leeuwerck, PT · Sub investigator
    • Audrey Riga, MSc · Sub investigator
    • Damien Bontemps, student · Sub investigator
    • Nicolas-Thomas Babuin, student · Sub investigator
  • Department of Neurology, CHU Mont-Godinne
    Yvoir, Namur, Belgium
    Recruiting
08

References and documents

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. PubMed 29326573 ↗
  • 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. PubMed 31088342 ↗
  • 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. PubMed 29420360 ↗
  • 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. PubMed 35300709 ↗
  • 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. PubMed 33433485 ↗

Individual participant data

Plan to share: Yes — the precise IPD plan has to be worked out in order to find the best public repository

Supporting information: Study protocol

Time frame: Up to 2 years after publication of the scientific articles

Access criteria: none (public)

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03974750
Lead sponsor
University Hospital of Mont-Godinne
Collaborators
Université Catholique de Louvain
Responsible party
Pr Yves Vandermeeren, MD, PhD (MD, PhD, Neurologist, Principal Investigator, Clinical Professor, University Hospital of Mont-Godinne) — Principal investigator
First posted
Jun 5, 2019
Start date
Jul 1, 2017
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Apr 3, 2025

Study contacts

Yves Vandermeeren, MD, PhD
Contact
yves.vandermeeren@uclouvain.be
+3281423321
Yves Y Vandermeeren, MD, PhD
principal investigator · Université catholique de Louvain, Institute of NeuroScience (IONS) NEUR / CHU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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