Acute StrokeMLAS6NCT07826832
Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke
A study testing REAplan® and Dextrain® Manipulandum in people with Acute Stroke and Chronic Stroke Patient, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
To test the capacity of healthy individuals, chronic and acute stroke patients to learn and retain a complex unimanual or bimanual motor skill, trained on the neurorehabiliation robot REAplan® et the Dextrain® device. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke, Chronic Stroke Patient, Healthy Individuals (Controls)
- 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
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 18 May 2026to 31 Dec 2031
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acute stroke (between day 2 and day 21 post-stroke) or chronic stroke (>6 mois)
- aged 40-90 years
- with a single demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
- 40-90 years
Who cannot join
- [for acute paitents] "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 stroke/dementia/psychiatric condition
Show all 12Show fewer
- HEALTHY INDIVIDUALS
- "classical" contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- medical history with a previous stroke/relevant neurological deficit
- drug/alcohol abuse
- psychiatric condition/dementia
- having already used the robotic devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU UCL Namur
Yvoir, Namur, 5530
Laura Santelé, MSc, +32 (0)81 42 34 91, laura.santele@uclouvain.be
Yves Vandermeeren, MD, PhD, +32 (0)81 42 33 21, yves.vandermeeren@uclouvain.be
About this study
Official title: Comparison of Unimanual Versus Bimanual Motor Skill Learning (Proximal and Distal) After Stroke by Means of Robotics (REA²Plan® and Dextrain®) and Multimodal Brain Imaging (VLSM, DTI, NODDI, DIAMOND)
To test the capacity of healthy individuals, chronic and acute stroke patients to learn and retain a complex unimanual or bimanual motor skill, trained on the neurorehabiliation robot REAplan® et the Dextrain® device. The goals are (1) to compare head-to-head bimanual versus unimanual motor learning (in the proximal and distal upper limb, UL) during the acute - early subactue stage of stroke with robotics and (2) to identify the neural substrates associated with (and deficits in) unimanual versus bimanual motor control (proximal and distal) after stroke by means of multimodal brain imaging.
Read the detailed description
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabiliation robot REAplan® and Dextrain® device.
They will practice a task on the robot REAplan® (unimanual or bimanual version), requiring movements with the affected arm (unimanual version) and complex, coordinated movements with both arms (bimanual version). They will practice another task on the Dextrain® device, also in unimanual and bimanual version.
In addition, several standardized clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...)
- Being tested
- REAplan®, Dextrain® Manipulandum
- Keywords
- Motor Skill Learning, Upper Limb, Acute Stroke, Chronic Stroke, Rehabilitation, Subacute stroke, Robotics, MRI
- 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 one or two arms
Dextrain® ManipulandumDevice
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
| Study group | Role | What they receive |
|---|---|---|
| Bimanual tasks | Experimental | Training on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the bimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a bimanual version of the Targeting task. Receives: Device: REAplan®; Device: Dextrain® Manipulandum |
| Unimanual tasks | Experimental | Training on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the unimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a unimanual version of the Targeting task. Receives: Device: REAplan®; Device: Dextrain® Manipulandum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
Unimanual/bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy, in arbitrary units (SAT = speed (cm/s)/error (cm²).C, where C=1cm.s)
Measured: Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode
bimanual Coordination factor (bi-CO) 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 optimal trajectory between 2 targets and the actual trajectory
Measured: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
bimanual Coordination factor (bi-CO) measured by the Dextrain(R) Manipulandum
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both hands
Measured: change between baseline (Day 1) and after training (Day 3)
Hold time measured by the Dextrain® Manipulandum
The amount of time the cursor remains inside the target zone
Measured: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
Secondary outcomes (12)
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) and transfer between Day 3 and Day 1 on the untrained mode
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Measured: Baseline
Diffusion Tensor Imaging (DTI)
Fractional Anisotrophy, Mean/Axial/Radial Diffusivity
Measured: Baseline
Fugl Meyer Upper Extremity (FMA-UE)
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment
Measured: Day1
Box and Block test
Measures unilateral gross dexterity by moving as many small wooden blocks as possible from one side to the other side of the box within 60 seconds. The task is performed seperately with each hand. Score range: 0-150 for each hand. The score corresponds to the number of blocks successfully transferred in one minute. A higher score indicates better gross manual dexterity and upper-limb function.
Measured: Day1
Purdue Pegboard Test
Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks
Measured: Day1
Oxford Cognitive Screen
A first-line, stroke-specific and domain-specific cognitive screening tool, inclusive for patients with aphasia and neglect. Domains assessed: Language, Praxis, Number, Memory, Spatial and Controlled Attention. It provides a cognitive profile showing both preserved and impaired abilities
Measured: Day2
Key WAIS IV
A paper-pen test to asses processing speed and working memory.
Measured: Day2
Fatigue Visual Analog Scale
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: Every days, mean of the three days
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
Intrinsic Motivation Inventory
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start18 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies 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
- 200 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
- NCT07826832
- Sponsor's protocol ID
- B039201938990 - part 6
- Acronym
- MLAS6
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 17 Sep 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Unimanual Versus Bimanual Motor Skill Learning (Proximal and Distal) After Stroke by Means of Robotics (REA²Plan® and Dextrain®) and Multimodal Brain Imaging (VLSM, DTI, NODDI, DIAMOND)
- ClinicalTrials.gov ID
- NCT07826832
- Acronym / sponsor ID
- MLAS6 / B039201938990 - part 6
- Keywords
- Motor Skill Learning, Upper Limb, Acute Stroke, Chronic Stroke, Rehabilitation, Subacute stroke, Robotics, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 17 Sep 2026 (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.
To test the capacity of healthy individuals, chronic and acute stroke patients to learn and retain a complex unimanual or bimanual motor skill, trained on the neurorehabiliation robot REAplan® et the Dextrain® device. The goals are (1) to compare head-to-head bimanual versus unimanual motor learning (in the proximal and distal upper limb, UL) during the acute - early subactue stage of stroke with robotics and (2) to identify the neural substrates associated with (and deficits in) unimanual versus bimanual motor control (proximal and distal) after stroke by means of multimodal brain imaging.
Detailed description
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabiliation robot REAplan® and Dextrain® device.
They will practice a task on the robot REAplan® (unimanual or bimanual version), requiring movements with the affected arm (unimanual version) and complex, coordinated movements with both arms (bimanual version). They will practice another task on the Dextrain® device, also in unimanual and bimanual version.
In addition, several standardized clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimanual tasks | Experimental | Device: REAplan®, Device: Dextrain® ManipulandumTraining on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the bimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a bimanual version of the Targeting task. |
| Unimanual tasks | Experimental | Device: REAplan®, Device: Dextrain® ManipulandumTraining on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the unimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a unimanual version of the Targeting task. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute stroke (between day 2 and day 21 post-stroke) or chronic stroke (>6 mois)
- aged 40-90 years
- with a single demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
- 40-90 years
Key exclusion criteria (12 listed)
- [for acute paitents] "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 one or two arms | Device | Bimanual tasks, Unimanual tasks |
| Dextrain® Manipulandummotor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands | Device | Bimanual tasks, Unimanual tasks |
Primary outcome
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
Time frame: Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode
Unimanual/bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy, in arbitrary units (SAT = speed (cm/s)/error (cm²).C, where C=1cm.s)
bimanual Coordination factor (bi-CO) 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) and transfer between Day 3 and Day 1 on the untrained mode
tracking error between the optimal trajectory between 2 targets and the actual trajectory
bimanual Coordination factor (bi-CO) measured by the Dextrain(R) 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 hands
Hold time measured by the Dextrain® Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
The amount of time the cursor remains inside the target zone
12 secondary outcomes
Coactivation measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
Voxel-based Lesion Symptom Mapping (VLSM)
Time frame: Baseline
Diffusion Tensor Imaging (DTI)
Time frame: Baseline
Fugl Meyer Upper Extremity (FMA-UE)
Time frame: Day1
Box and Block test
Time frame: Day1
Purdue Pegboard Test
Time frame: Day1
Oxford Cognitive Screen
Time frame: Day2
Key WAIS IV
Time frame: Day2
Fatigue Visual Analog Scale
Time frame: Every days, mean of the three days
Shoulder Abduction Finger Extension (SAFE) test
Time frame: Day 1
Modified Ashworth Scale (mAS)
Time frame: Day 1
Intrinsic Motivation Inventory
Time frame: Day 3
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 17 Sep 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
1 site 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 Acute Stroke and Chronic Stroke Patient, run by University Hospital of Mont-Godinne at 1 site 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 12 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (0)81 42 33 21, yves.vandermereen@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot (time frame: Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode). The study lists 6 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 17 Sep 2026.