An interventional study of REAplan® and Dextrain® Manipulandum in Acute Stroke, Chronic Stroke Patient and Healthy Individuals (Controls), sponsored by University Hospital of Mont-Godinne. Recruiting at 1 site in Belgium. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University Hospital of Mont-Godinne · Not applicable, Interventional, and Basic science
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.
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, ...)
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 200 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.
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 (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.
Device: REAplan® · Device: Dextrain® Manipulandum
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.
Device: REAplan® · Device: Dextrain® Manipulandum
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
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)
Time frame: 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
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 optimal trajectory between 2 targets and the actual trajectory
Time frame: 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
Time frame: 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
Time frame: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
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) and transfer between Day 3 and Day 1 on the untrained mode
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Time frame: Baseline
Diffusion Tensor Imaging (DTI)
Fractional Anisotrophy, Mean/Axial/Radial Diffusivity
Time frame: Baseline
Fugl Meyer Upper Extremity (FMA-UE)
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment
Time frame: 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.
Time frame: Day1
Purdue Pegboard Test
Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks
Time frame: 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
Time frame: Day2
Key WAIS IV
A paper-pen test to asses processing speed and working memory.
Time frame: 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.
Time frame: 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.
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
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
Time frame: Day 3
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 10 years.
Access criteria: Login user of the Hospital of CHU UCL Namur - Site Godinne
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2028, 31 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 31 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