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NCT Number: NCT07826832

Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Patient Healthy Individuals (Controls) Nervous System Diseases Stroke Stroke (Subacute) Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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, ...)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

STROKE PATIENTS

Inclusion criteria

  • 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

Exclusion criteria

  • [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

HEALTHY INDIVIDUALS

Inclusion criteria

  • 40-90 years

Exclusion criteria

  • "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

Treatment and study plan

REAplan®

Device

motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms

Dextrain® Manipulandum

Device

motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands

Primary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

    binary measure of unasked fingers activated above the force threshold

  2. Voxel-based Lesion Symptom Mapping (VLSM)

    Time frame: Baseline

    Diffusion Weighted Imaging (DWI)

  3. Diffusion Tensor Imaging (DTI)

    Time frame: Baseline

    Fractional Anisotrophy, Mean/Axial/Radial Diffusivity

  4. Fugl Meyer Upper Extremity (FMA-UE)

    Time frame: Day1

    Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment

  5. Box and Block test

    Time frame: Day1

    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.

  6. Purdue Pegboard Test

    Time frame: Day1

    Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks

  7. Oxford Cognitive Screen

    Time frame: Day2

    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

  8. Key WAIS IV

    Time frame: Day2

    A paper-pen test to asses processing speed and working memory.

  9. Fatigue Visual Analog Scale

    Time frame: Every days, mean of the three days

    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.

  10. Shoulder Abduction Finger Extension (SAFE) test

    Time frame: Day 1

    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.

  11. Modified Ashworth Scale (mAS)

    Time frame: Day 1

    clinical measure of spasticity. For each of the 8 subitems, the range is 0-4. A higher score means a higher level of spasticity

  12. Intrinsic Motivation Inventory

    Time frame: Day 3

    The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Santelé, MSc

CONTACT

[email protected]

+32 (0)81 42 34 91

Yves Vandermeeren, MD, PhD

CONTACT

[email protected]

+32 (0)81 42 33 21

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Registry information

Official study 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)

Acronym: MLAS6

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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