An interventional study of REAplan® and Dextrain Manipulandum® in Stroke, Acute and Stroke, Subacute, sponsored by University Hospital of Mont-Godinne. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University Hospital of Mont-Godinne · Not applicable, Interventional, and Basic science
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 160 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital of Mont-Godinne is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ACUTE STROKE PATIENTS:
Inclusion Criteria:
Exclusion Criteria:
HEALTHY INDIVIDUALS:
Inclusion Criteria:
Exclusion Criteria:
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
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
Device: REAplan® · Device: Dextrain Manipulandum®
motor skill learning with the REAplan® rehabilitation robot, to be performed with both arms
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with both hands
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: change between baseline (Day 1) and after training (Day 3)
Reaction time measured by the Dextrain Manipulandum
time between the target appearance and when the force applied exceeds threshold
Time frame: 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
Time frame: 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
Time frame: change between baseline (Day 1) and after training (Day 3)
Hold time measured by the Dextrain Manipulandum
time of plateau maintenance
Time frame: change between baseline (Day 1) and after training (Day 3)
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Time frame: Baseline
Diffusion Tensor Imaging (DTI)
Fractional Anisotropy
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 1
Plan to share: Yes — Data Management Plan REDCap
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will become available during the beginning of the study and for 20 years.
Access criteria: Login user of the Hospital of CHU UCL Namur -Site Godinne
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Mar 2028, 59 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 59 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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University Hospital of Mont-Godinne