An interventional study of REAplan(R) in Stroke, Acute, 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 acute phase of stroke is characterized by an enhancement of neural plasticity which supports rapid motor recovery. It is unclear whether acute stroke patients can acquire new motor skills with their affected upper limb. The aims of this research program are:
Over 3 consecutive days, the subjects will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/). They will practice 2 serious games on the robot.
In order to differentiate the effect of motor control recovery from that of MskL, the acute stroke patients will be randomised 4/1 to "MskL" (n=120) ,to "motor control recovery" (n=30) or to "conventional" group (n=15) with a minimisation software. The experimental design will be similar except that the "motor control recovery" group will practice the serious game EASY instead of CIRCUIT (see below) and the "conventional" group will practice conventional therapy instead of CIRCUIT. The performances on both EASY \& CIRCUIT will be compared between groups (subjects in both groups will perform the EASY \& CIRCUIT tasks).The total time of rehabilitation will be the same.
The motor skill learning setup (CIRCUIT + EASY) that we 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 as a cursor quickly and accurately as possible by controlling the handle of the robot with their affected hand/arm. For the other task EASY (a brick busters serious game), the aim will be to go back and forth between walls presented in different locations. The CONVENTIONAL therapy will consist in classical exercices focused in the upper limb administered by occupational therapist.
The subacute stroke phase is a unique opportunity to investigate the role of brain structures in motor learning/control. Compared to chronic impairments (> 6 months post-stroke), the subacute phase provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. To clarify the role of different brain structures in 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 MskL scores on a voxel-by-voxel basis.
In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions. The subjects will practice serious games on the robot REAplan (R), requiring movements with the affected arm (unimanual tasks).
And, we used a Dextrain® tool which allows quantification of key components of manual dexterity : forces, selectivity (independance of fingers movement) and coactivation of the fingers.Moreover, we added a Transcranial magnetic stimulation (TMS), as a tool for predicting recovery of motor function after stroke.
In addition to the (sub)acute stroke patients, 4 others groups will be recruited for this study : a group of acute stroke patients who will receive "conventional rehabilitation" and be shortly tested on the robot (N=15), a group of chronic stroke patients (stroke > 6 months) who will not be hospitalized and will not undergo MRI (N=30), a group of healthy individuals who will not undergo MRI (N=50) and a group of patients with a transient global amnesia which is a sudden, temporary episode (\<24hours) of memory loss (N=15).
Subjects in these 4 groups will be randomized 1/1 in the two arms ("MSkL" versus "motor control recovery" arms), except the patients with a TGA who will be included in the "MSkL" arm only.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 245 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:
PATIENTS WITH TRANSIENT GLOBAL AMNESIA:
Clinical diagnosis, criteria of Hodge \& Warlow (1990):
Inclusion criteria:
Exclusion criteria:
HEALTHY INDIVIDUALS:
Inclusion Criteria:
Exclusion Criteria:
CHRONIC STROKE PATIENTS:
Inclusion Criteria:
Exclusion Criteria:
Intervention: training on the REAplan robot with a serious game based on motor skill learning (MSkL) serious game, the CIRCUIT.
Device: REAplan(R)
Training on the REAplan robot with a serious game that requires similar type and amount of movements but does not rely on motor skill learning (EASY), a brick buster game.
Device: REAplan(R)
Training sessions with classical exercices focused on the upper limb administered by occupation therapist.
Device: REAplan(R)
motor skill learning with the REAplan(R) rehabilitation robot, to be perfomed with the affected arm
change in SAT (CIRCUIT)
Speed/ Accuracy Trade-off
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
total distance travelled (EASY)
total distance travelled between the walls of the brick busters (in cm)
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Fugl Meyer Upper Extremity Test
Tests impairments of the upper limb after stroke
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Arm Motor Ability (AMA) test
Measure disabilities of the upper limb after stroke
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Fatigue Visual Analog Scale (VAS)
Visual Analog Scale to evaluate fatigue between 0 and 10. The maximum value (10) indicate a high level of fatiguability.
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Voxel-based Lesion Symptom Mapping (VLSM)
High-resolution 3D-MRI, diffusion MRI (DWI) \& perfusion MRI (PWI with Arterial SPin Labelling technique) will be acquired. The stroke areas will be drawn with MRIcron as volumes of interest (VOI) in native space and compared.
Time frame: Baseline
Dextrain®
Quantitative assessment of the manual dexterity : fingers strength and selectivity, coactivation.
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Grober and Buschke test (16 items) (for patients with trasient global amnesia)
Assessement of episodic verbal memory
Time frame: Baseline
Brief Visuospatial Memory Test-Revised
Measure of visuospatial memory (for patients with trasient global amnesia)
Time frame: Baseline
Forces of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING)
To evaluate the Force of the upper limb after stroke (Newton)
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Spectral Arc Lenght on the REAplan robot (CIRCUIT, EASY, REACHING)
Movement smoothness quantification
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
Total distance of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING)
Measure of total distance traveled during the training (cm)
Time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)
transcranial magnetic stimulation (TMS)
Measure of the prediction recovery after stroke
Time frame: correlation with the measure realized Day 1 with progression of the motor skill learning (change between Baseline Day1 and Day 3)
Plan to share: Yes — the precise IPD plan has to be worked out if an easy and user-friendly solution is available, we intend to make the data available (after anonymisation of personal data).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will become available during thebeggining 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 Jan 2020 (actual). Primary completion is estimated for May 2030, 124 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 124 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