Stroke, AcuteMLAS4NCT05760846
Bimanual Motor Skill Learning in Acute Stroke
A study testing REAplan® and Dextrain Manipulandum® in people with Stroke, Acute and Stroke, Subacute, run by University Hospital of Mont-Godinne at 2 sites in Belgium.
Trial summary
The subacute phase of stroke provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. The recovery from motor impairment has been extensively studied, but it is currently unknown whether motor skill learning (MSkL) is enhanced or impaired… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Stroke, Subacute
- What is being tested?
- REAplan® and Dextrain Manipulandum®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesBelgium
- Study dates
- 17 Apr 2023to Oct 2028
- 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
- acute stroke (< 21 days)
- aged 18-90 years
- with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
- 18-90 years
Who cannot join
- " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- difficulty in understanding or executing commands
- drug/alcohol abuse
- severe aphasia / cognitive deficits interfering with study
- inability to complete the tasks (i.e. full paralysis of the arm)
- multiple strokes / dementia / psychiatric condition
Show all 10Show fewer
- HEALTHY INDIVIDUALS:
- medical history with a previous stroke / relevant neurological deficit
- drug/alcohol abuse
- psychiatric condition/ dementia
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
CHU UCL Namur
Yvoir, Namur, 5530
Coralie van Ravestyn, +3281423406, coralie.vanravestyn@uclouvain.be
- Recruiting
University Hospital CHU Dinant Godinne UCL
Yvoir, 5530
Yves Vandermeeren, MD, PhD, yves.vandermeeren@uclouvain.be
About this study
Official title: Exploring the Neural Substrates of Proximal and Distal Bimanual Motor Skill Learning Through Robotics and Multimodal Brain Imaging
The subacute phase of stroke provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. The recovery from motor impairment has been extensively studied, but it is currently unknown whether motor skill learning (MSkL) is enhanced or impaired during acute stroke, especially bimanual motor skill learning (bim-MSkL), which likely requires more motor-attentional-cognitive resources than unimanual MSkL.
The goals of this project are: to determine the neural substrates critical to achieve proximal and distal bimanual motor skill learning (bim-MSkL) by specifying whether (sub)acute stroke to different brain areas (cortical and subcortical) induce specific deficits in bimanual and/or distal bim-MSkL, which behavioral components are involved in bim-MSkL, and whether damage to the motor, sensory and inter-hemispheric pathways specifically impairs proximal and/or distal bim-MSkL.
Read the detailed description
Over 3 consecutive days, the patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal bim-MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal bim-MSkL.
For proximal bim-MSkL, patients will train over the 3 days on the serious game Circuit on the bimanual REAplan® and will be randomised to two different bimanual versions. By this means, the investigators will explore the components of bim-MSkL in acute stroke patients.
The motor skill learning setup (Circuit) that was developed and successfully used in healthy individuals and stroke patients has already been implemented in the REAplan® environment and will be used as innovative serious games based on a speed/accuracy trade-off (SAT), allowing a detailed analysis of motor skill learning components (speed, accuracy, SAT, movement smoothness, dynamics...). For the serious game Circuit, who based on motor skill learning, the subjects will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handles of the robot with both arms.
For distal bim-MSkL, patients will train on a complex sequence of finger movements involving both hands. Each day, several successive repetitions of the sequence will be displayed, corresponding to one block. 3 to 6 blocks will be repeated, each separated by 30 sec of rest. After training on the third day, a new sequence will be repeated for 3 blocks to assess generalization.
To explore the role of different brain structures in bim-MskL, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and proximal/distal bim-MskL scores on a voxel-by-voxel basis.
Diffusion Tensor Imaging (DTI) will quantify the integrity of several white matter tracts, allowing through correlation analyses to unveil the white matter tracts crucial to achieve proximal and/or distal bim-MskL.
In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.
In addition to the (sub)acute stroke patients, a group of healthy individuals who will not undergo MRI (n=60) will be enrolled as control group. Subjects in this group will also be randomized 1/1 in the two versions of the bimanual Circuit task on the REAplan® robot.
- Conditions
- Stroke, Acute, Stroke, Subacute
- Being tested
- REAplan®, Dextrain Manipulandum®
- Keywords
- Motor Skill Learning, Upper limb, Acute stroke, Rehabilitation, Subacute stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAplan®Device
motor skill learning with the REAplan® rehabilitation robot, to be performed with both arms
Dextrain Manipulandum®Device
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with both hands
| Study group | Role | What they receive |
|---|---|---|
| Bimanual Circuit version 1 | Experimental | Training on the REAplan® robot with a serious game based on proximal motor skill learning (bim-MSkL) with the bimanual version 1 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL Receives: Device: REAplan®; Device: Dextrain Manipulandum® |
| Bimanual Circuit version 2 | Experimental | Training on the REAplan® robot with a serious game based on motor skill learning (MSkL) with bimanual version 2 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL Receives: Device: REAplan®; Device: Dextrain Manipulandum® |
What is being measured
The primary outcome is the main question the study is designed to answer.
bimanual Speed/Accuracy Trade-off (bi-SAT), bimanual Speed/Accuracy Trade-off measured by the REAplan® robot
bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Measured: change between baseline (Day 1) and after training (Day 3)
bimanual Coordination factor (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)
bi-Force, bimanual force 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)
Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain Manipulandum
Tracking error between the actual applied force and the target force
Measured: change between baseline (Day 1) and after training (Day 3)
Bimanual Dexterity Coordination Index measured by the Dextrain Manipulandum
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both thumb-index clamps
Measured: change between baseline (Day 1) and after training (Day 3)
Secondary outcomes (12)
Reaction time measured by the Dextrain Manipulandum
time between the target appearance and when the force applied exceeds threshold
Measured: change between baseline (Day 1) and after training (Day 3)
Rise time measured by the Dextrain Manipulandum
time between the reaction time and reaching the plateau
Measured: change between baseline (Day 1) and after training (Day 3)
Coactivation measured by the Dextrain Manipulandum
binary measure of unasked fingers activated above the force threshold
Measured: change between baseline (Day 1) and after training (Day 3)
Hold time measured by the Dextrain Manipulandum
time of plateau maintenance
Measured: change between baseline (Day 1) and after training (Day 3)
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Measured: Baseline
Diffusion Tensor Imaging (DTI)
Fractional Anisotropy
Measured: Baseline
Fugl Meyer Upper Extremity Test (FMA-UE)
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment.
Measured: Day1
Arm Motor Ability (AMA) test
Measure disabilities of the upper limb after stroke. Range: 0-100. A higher score means less disabilities in activities of daily living.
Measured: Day 1
Montreal Cognitive Assessment (MoCA)
Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space. Range: 0-30, higher score means no cognitive impairment.
Measured: Day 1
Fatigue Visual Analog Scale (VAS)
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. A higher score means a higher level of fatigue.
Measured: Day 1
Shoulder Abduction Finger Extension (SAFE) test
A prognostic determinant of the function of the hemiparetic upper limb (UL) after a stroke. For each of the 2 subitems, the range is 0-5. A score of 5 means normal power. A score of 0 means no contraction possible.
Measured: Day 1
Modified Ashworth Scale (mAS)
clinical measure of spasticity. For each of the 8 subitems, the range is 0-4. A higher score means a higher level of spasticity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start17 Apr 2023
- Primary completionMar 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
- Investigators
- Yves Vandermeeren, MD, PhD, Principal investigator, UCLouvain IONS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760846
- Sponsor's protocol ID
- Bim-MSkL acute
- Acronym
- MLAS4
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Management Plan REDCap
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Neural Substrates of Proximal and Distal Bimanual Motor Skill Learning Through Robotics and Multimodal Brain Imaging
- ClinicalTrials.gov ID
- NCT05760846
- Acronym / sponsor ID
- MLAS4 / Bim-MSkL acute
- Conditions
- Stroke, Acute, Stroke, Subacute
- Keywords
- Motor Skill Learning, Upper limb, Acute stroke, Rehabilitation, Subacute stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subacute phase of stroke provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. The recovery from motor impairment has been extensively studied, but it is currently unknown whether motor skill learning (MSkL) is enhanced or impaired during acute stroke, especially bimanual motor skill learning (bim-MSkL), which likely requires more motor-attentional-cognitive resources than unimanual MSkL.
The goals of this project are: to determine the neural substrates critical to achieve proximal and distal bimanual motor skill learning (bim-MSkL) by specifying whether (sub)acute stroke to different brain areas (cortical and subcortical) induce specific deficits in bimanual and/or distal bim-MSkL, which behavioral components are involved in bim-MSkL, and whether damage to the motor, sensory and inter-hemispheric pathways specifically impairs proximal and/or distal bim-MSkL.
Detailed description
Over 3 consecutive days, the patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal bim-MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal bim-MSkL.
For proximal bim-MSkL, patients will train over the 3 days on the serious game Circuit on the bimanual REAplan® and will be randomised to two different bimanual versions. By this means, the investigators will explore the components of bim-MSkL in acute stroke patients.
The motor skill learning setup (Circuit) that was developed and successfully used in healthy individuals and stroke patients has already been implemented in the REAplan® environment and will be used as innovative serious games based on a speed/accuracy trade-off (SAT), allowing a detailed analysis of motor skill learning components (speed, accuracy, SAT, movement smoothness, dynamics...). For the serious game Circuit, who based on motor skill learning, the subjects will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handles of the robot with both arms.
For distal bim-MSkL, patients will train on a complex sequence of finger movements involving both hands. Each day, several successive repetitions of the sequence will be displayed, corresponding to one block. 3 to 6 blocks will be repeated, each separated by 30 sec of rest. After training on the third day, a new sequence will be repeated for 3 blocks to assess generalization.
To explore the role of different brain structures in bim-MskL, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and proximal/distal bim-MskL scores on a voxel-by-voxel basis.
Diffusion Tensor Imaging (DTI) will quantify the integrity of several white matter tracts, allowing through correlation analyses to unveil the white matter tracts crucial to achieve proximal and/or distal bim-MskL.
In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.
In addition to the (sub)acute stroke patients, a group of healthy individuals who will not undergo MRI (n=60) will be enrolled as control group. Subjects in this group will also be randomized 1/1 in the two versions of the bimanual Circuit task on the REAplan® robot.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimanual Circuit version 1 | Experimental | Device: REAplan®, Device: Dextrain Manipulandum®Training on the REAplan® robot with a serious game based on proximal motor skill learning (bim-MSkL) with the bimanual version 1 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL |
| Bimanual Circuit version 2 | Experimental | Device: REAplan®, Device: Dextrain Manipulandum®Training on the REAplan® robot with a serious game based on motor skill learning (MSkL) with bimanual version 2 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute stroke (< 21 days)
- aged 18-90 years
- with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
- 18-90 years
Key exclusion criteria (10 listed)
- " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- difficulty in understanding or executing commands
- drug/alcohol abuse
- severe aphasia / cognitive deficits interfering with study
- inability to complete the tasks (i.e. full paralysis of the arm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REAplan®motor skill learning with the REAplan® rehabilitation robot, to be performed with both arms | Device | Bimanual Circuit version 1, Bimanual Circuit version 2 |
| Dextrain Manipulandum®motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with both hands | Device | Bimanual Circuit version 1, Bimanual Circuit version 2 |
Primary outcome
bimanual Speed/Accuracy Trade-off (bi-SAT), bimanual Speed/Accuracy Trade-off measured by the REAplan® robot
Time frame: change between baseline (Day 1) and after training (Day 3)
bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
bimanual Coordination factor (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 force 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)
Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Tracking error between the actual applied force and the target force
Bimanual Dexterity Coordination Index measured by the Dextrain Manipulandum
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 thumb-index clamps
12 secondary outcomes
Reaction time measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Rise time measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Coactivation measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Hold time measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Voxel-based Lesion Symptom Mapping (VLSM)
Time frame: Baseline
Diffusion Tensor Imaging (DTI)
Time frame: Baseline
Fugl Meyer Upper Extremity Test (FMA-UE)
Time frame: Day1
Arm Motor Ability (AMA) test
Time frame: Day 1
Montreal Cognitive Assessment (MoCA)
Time frame: Day 1
Fatigue Visual Analog Scale (VAS)
Time frame: Day 1
Shoulder Abduction Finger Extension (SAFE) test
Time frame: Day 1
Modified Ashworth Scale (mAS)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Data Management Plan REDCap
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves Vandermeeren, MD, PhD principal investigator
UCLouvain IONS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAplan® and Dextrain Manipulandum® in people with Stroke, Acute and Stroke, Subacute, 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 12 Aug 2026. 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 (+32 81 42 33 21, yves.vandermeeren@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bimanual Speed/Accuracy Trade-off (bi-SAT), bimanual Speed/Accuracy Trade-off measured by the REAplan® robot (time frame: change between baseline (Day 1) and after training (Day 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.