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AzTrials

StrokebimMsKLNCT03974750

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

A study testing Bimanual motor skill learning with the REAplan(R) rehabilitation robot in people with Stroke, run by University Hospital of Mont-Godinne at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Bimanual motor skill learning with the REAplan(R) rehabilitation robot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesBelgium
Study dates
1 Jul 2017to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 10Show fewer
  • HEALTHY INDIVIDUALS :
  • neurological conditions interfering with the study
  • drug/alcohol abuse
  • pyschiatric condition

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yves Vandermeeren, MD, PhD contact

+3281423321

yves.vandermeeren@uclouvain.be

Belgium2 sites, 2 recruiting

  • CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit

    Yvoir, Namur, 5530

    Yves Vandermeeren, MD, PhD, +32 81 42 3321, yves.vandermeeren@uclouvain.be

    Mie Leeuwerck, PT

    Recruiting

  • Department of Neurology, CHU Mont-Godinne

    Yvoir, Namur

    Yves Vandermeeren, MD,PhD, 081 42 3321 ext. +32, yves.vandermeeren@uclouvain.be

    Recruiting

Other trials in Belgium

About this study

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, ...).

Conditions
Stroke
Being tested
Bimanual motor skill learning with the REAplan(R) rehabilitation robot
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bimanual motor skill learning with the REAplan(R) rehabilitation robotDevice

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

Study groups in NCT03974750
Study groupRoleWhat they receive
interventionExperimentalTraining on the rehabilitation robot REAplan(R) to learn complex, coordinated bimanual movements
Receives: Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot
control interventionActive comparatorTraining on the rehabilitation robot REAplan(R) with simple movements
Receives: Device: Bimanual motor skill learning with the REAplan(R) rehabilitation robot

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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)

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

Secondary outcomes (8)

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

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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start1 Jul 2017
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Evaluation of bimanual motor skill learning Motor skill learning with a rehabilitation robot
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974750
Sponsor's protocol ID
bimMsKL
Acronym
bimMsKL
Status last verified
Mar 2025
First submitted
28 May 2019
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: the precise IPD plan has to be worked out in order to find the best public repository

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

Questions about this trial

What is this clinical trial studying?

A study testing Bimanual motor skill learning with the REAplan(R) rehabilitation robot in people with Stroke, run by University Hospital of Mont-Godinne at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yves Vandermeeren, MD, PhD (+3281423321, yves.vandermeeren@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot (time frame: change between baseline (Day 1) and after training (Day 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03974750, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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