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
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
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- 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