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Stroke, AcuteNCT04171856

Exploring Motor Learning in Acute Stroke Through Robotics

A study testing REAplan(R) in people with Stroke, Acute, run by University Hospital of Mont-Godinne at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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: 1. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Acute
What is being tested?
REAplan(R)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
2 sitesBelgium
Study dates
1 Jan 2020to 1 Jul 2040
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • acute stroke (> 21 days)
  • aged 18-90 years
  • with a stroke lesion on brain imaging
  • Transient global amnesia
  • 8-90 years old
  • Be able to perform 3 consecutive sessions on a rehabilitation robot
Show all 10Show fewer
  • 18-90 years
  • chronic stroke (>6 months)
  • aged 18-90 years
  • with a stroke lesion on brain imaging

Who cannot join

  • " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophoby, etc ...)
  • difficulty in understanding or executing commands
  • drug/alcohol abuse
  • severe aphasia / cognitive deficits interfering with study
  • inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
  • multiple strokes / dementia / psychiatric condition
Show all 28Show fewer
  • PATIENTS WITH TRANSIENT GLOBAL AMNESIA:
  • Clinical diagnosis, criteria of Hodge \& Warlow (1990):
  • Anterograde amnesia observed by a witness
  • No alteration of consciousness or loss of identity
  • Cognitive dysfunction limited to amnesia
  • Lack of focused neurological deficit or argument for a comitiality
  • Absence of head trauma
  • Symptom resolution within 24 hours
  • Possible existence of vegetative symptoms
  • Severe aphasia / cognitive deficits interfering with study
  • Psychiatric disorders
  • Alcohol / drug addiction
  • HEALTHY INDIVIDUALS:
  • medical history with a previous stroke/neurological deficit
  • drug/alcohol abuse
  • psychiatric condition/ dementia
  • CHRONIC STROKE PATIENTS:
  • difficulty in understanding or executing commands
  • drug/alcohol abuse
  • severe aphasia / cognitive deficits interfering with study
  • inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
  • multiple strokes / dementia / psychiatric condition

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yves Vandermeeren, MD, PhD contact

+32 81 42 33 21

yves.vandermeeren@uclouvain.be

Eloïse Gerardin, MSc contact

+32 81 42 33 48

eloise.gerardin@uclouvain.be

Belgium2 sites, 2 recruiting
  • CHU UCL Namur

    Yvoir, Namur, 5530

    Eloïse Gerardin, +3281423348, eloise.gerardin@uclouvain.be

    Recruiting
  • University Hospital CHU Dinant Godinne UCL

    Yvoir, 5530

    Yves Vandermeeren, MD, PhD, yves.vandermeeren@uclouvain.be

    Not yet recruiting

Other trials in Belgium

About this study

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:

  1. To test the capacity of acute stroke patients (< 21 days) to learn and retain a complex unimanual motor skill.
  2. To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning.
  3. To compare acute stroke patients with healthy individuals and with chronic stroke patients.
Read the detailed description

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.

Conditions
Stroke, Acute
Being tested
REAplan(R)
Keywords
Acute stroke, Motor skill learning, Upper limb, Rehabilitation, Subacute stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REAplan(R)Device

    motor skill learning with the REAplan(R) rehabilitation robot, to be perfomed with the affected arm

Study groups in NCT04171856
Study groupRoleWhat they receive
Motor Skill Learning (CIRCUIT)ExperimentalIntervention: training on the REAplan robot with a serious game based on motor skill learning (MSkL) serious game, the CIRCUIT.
Receives: Device: REAplan(R)
Motor control recovery (EASY)Active comparatorTraining 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.
Receives: Device: REAplan(R)
ConventionalActive comparatorTraining sessions with classical exercices focused on the upper limb administered by occupation therapist.
Receives: Device: REAplan(R)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in SAT (CIRCUIT)

    Speed/ Accuracy Trade-off

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  2. total distance travelled (EASY)

    total distance travelled between the walls of the brick busters (in cm)

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

Secondary outcomes (11)
  1. Fugl Meyer Upper Extremity Test

    Tests impairments of the upper limb after stroke

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  2. Arm Motor Ability (AMA) test

    Measure disabilities of the upper limb after stroke

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  3. 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.

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  4. 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.

    Measured: Baseline

  5. Dextrain®

    Quantitative assessment of the manual dexterity : fingers strength and selectivity, coactivation.

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  6. Grober and Buschke test (16 items) (for patients with trasient global amnesia)

    Assessement of episodic verbal memory

    Measured: Baseline

  7. Brief Visuospatial Memory Test-Revised

    Measure of visuospatial memory (for patients with trasient global amnesia)

    Measured: Baseline

  8. Forces of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING)

    To evaluate the Force of the upper limb after stroke (Newton)

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  9. Spectral Arc Lenght on the REAplan robot (CIRCUIT, EASY, REACHING)

    Movement smoothness quantification

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  10. Total distance of the upper limb on the REAplan robot (CIRCUIT, EASY, REACHING)

    Measure of total distance traveled during the training (cm)

    Measured: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)

  11. transcranial magnetic stimulation (TMS)

    Measure of the prediction recovery after stroke

    Measured: correlation with the measure realized Day 1 with progression of the motor skill learning (change between Baseline Day1 and Day 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start1 Jan 2020
  3. Primary completion1 May 2030 (estimated)
  4. Study completion1 Jul 2040 (estimated)

Resources

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
245 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04171856
Sponsor's protocol ID
B039201938990
Status last verified
Aug 2026
First submitted
12 Nov 2019
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Questions about this trial

What is this clinical trial studying?

A study testing REAplan(R) in people with Stroke, Acute, run by University Hospital of Mont-Godinne at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yves Vandermeeren, MD, PhD (+32 81 42 33 21, yves.vandermeeren@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in SAT (CIRCUIT) (time frame: change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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