Stroke, AcuteMLAS5NCT07822633
Inter-Limb Transfer in Acute Stroke
A study testing REAplan® and Dextrain Manipulandum® in people with Stroke, Acute and Stroke (Subacute), run by University Hospital of Mont-Godinne at 2 sites in Belgium.
Trial summary
This study aims to investigate whether the improvements achieved through motor skill learning (MSkL) with the ipsilesional upper limb (UL) are transferred to the contralesional UL during the (sub)acute stroke phase, and to identify the neural substrates underlying this inter-limb transfer. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute, Stroke (Subacute), Healthy Individuals (Controls)
- What is being tested?
- REAplan® and Dextrain Manipulandum®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesBelgium
- Study dates
- 11 Aug 2026to Jan 2032
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First acute ischemic or hemorrhagic stroke
- Between the 2nd and 21st day post-stroke
- Age: 40-90 years
- Ability to complete the 3 consecutive sessions
- 40-90 years
- availability to complete three consecutive sessions.
Show all 10Show fewer
- single stroke confirmed by brain imaging
- time since stroke onset >6 months
- age between 40-90 years
- availability to complete three consecutive sessions.
Who cannot join
- Stroke with multiple brain lesions
- Addiction (e.g., alcohol or drugs)
- Pregnancy
- Major cognitive impairment (e.g., depression, aphasia, dementia)
- Inability to perform or understand the required tasks
- Uncontrolled health conditions
Show all 21Show fewer
- " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- HEALTHY INDIVIDUALS:
- "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 or disease
- drug/alcohol abuse
- psychiatric condition/dementia
- having already used the robotic devices
- CHRONIC STROKE PATIENTS:
- Stroke with multiple brain lesions
- Addiction (e.g., alcohol or drugs)
- Pregnancy
- Major cognitive impairment (e.g., depression, aphasia, dementia)
- Inability to perform or understand the required tasks
- Uncontrolled health conditions
- having already used the robotic devices
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wumeng Wang, MSc contact
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Yves Vandermeeren, MD PhD, +32 81 42 33 21, yves.vandermeeren@uclouvain.be
Wumeng Wang, MSc, wumeng.wang@uclouvain.be
- Recruiting
CHU UCL Namur
Yvoir, Namur, 5530
Yves Vandermeeren, MD,PhD, +32 81 42 33 21, yves.vandermeeren@uclouvain.be
Wumeng Wang, MSc, wumeng.wang@uclouvain.be
About this study
Official title: Identifying Brain Regions Critical for Human Motor Learning Through Anatomic-functional Correlations of Deficits in Acute Stroke: Integrated Robotic and Voxel-based Lesion Symptom Mapping Approach
This study aims to investigate whether the improvements achieved through motor skill learning (MSkL) with the ipsilesional upper limb (UL) are transferred to the contralesional UL during the (sub)acute stroke phase, and to identify the neural substrates underlying this inter-limb transfer. To achieve this, healthy individuals, acute and chronic stroke patients will perform proximal and distal MSkL tasks using serious games implemented on robotic devices. This will be complemented by behavioural assessments and multimodal MRI.
Read the detailed description
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal MSkL.
Healthy individuals, acute and chronic stroke patients will be randomised equally to 2 different groups. One group of participants will train over the 3 days on the serious game Circuit on the REAplan® and the game Targeting on the Dextrain Manipulandum. The other one will only be assessed on day 1 and day 3 on the serious games and will not have any training.
For proximal upper limb with the serious game Circuit, the participants will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handle of the robot. A Reaching task and a Drawing task will be used to assess motor control.
For distal upper limb with the serious game Targeting, the participants will have to reach a series of targets with a cursor as quickly and accurately as possible by controlling their finger movements.
To explore the role of different brain structures in inter-limb transfer, 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 inter-limb transfer 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 this transfer.
Moreover, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.
- Being tested
- REAplan®, Dextrain Manipulandum®
- Keywords
- Motor Skill Learning, Upper limb, Acute stroke, Rehabilitation, Inter-limb transfer, Subacute stroke, Chronic stroke, Robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAplan®Device
motor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm
Dextrain Manipulandum®Device
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand
REAplan®Device
proximal motor control and motor skill assessement with the REAplan® rehabilitation robot, to be performed by each arm
Dextrain Manipulandum®Device
distal motor skill assessment with the Dextrain Manipulandum® dexterity tool to be performed by each hand
| Study group | Role | What they receive |
|---|---|---|
| Ipsilesional Group | Experimental | Participants will have trainings on the REAplan® robot using their ipsilesional arm with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device using their ipsilesional hand with a serious game based on distal MSkL.
Participants will have assessment with each of their arms on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL Receives: Device: REAplan®; Device: Dextrain Manipulandum® |
| Control Group | Experimental | Participants will only have assessment with each of their arms but not trainings on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL Receives: Device: REAplan®; Device: Dextrain Manipulandum® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Measured: change between baseline (Day 1) and after training (Day 3)
force measured by the REAplan® robot
forces exerted in the wrong direction by each arm (Newtons)
Measured: change between baseline (Day 1) and after training (Day 3)
Root Mean Square Error (RMSE) measured by the Dextrain Manipulandum
error between the coordinates of the target and the cursor
Measured: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Measured: change between baseline (Day 1) and after training (Day 3)
Secondary outcomes (11)
Hold time measured by the Dextrain Manipulandum
The amount of time the cursor remains inside the target zone
Measured: 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
Measured: change between baseline (Day 1) and after training (Day 3)
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Measured: Baseline
Diffusion Tensor Imaging (DTI)
Fractional Anisotropy
Measured: 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.
Measured: Day1
Oxford Cognitive Screen (OCS)
to identify cognitive impairments following stroke. Rather than providing only a single overall cognitive score, the OCS assesses several distinct cognitive domains (Language, Praxis, Number, Memory, Spatial and Controlled Attention) and produces a cognitive profile showing both preserved and impaired abilities.
Measured: Day2
Action Research Arm Test (ARAT)
evaluate upper-limb motor function and activity performance. Range: 0-57. higher scores indicating better upper-limb motor function
Measured: Day2
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.
Measured: Day 1
Intrinsic Motivation Inventory (IMI)
To assess participants' level of motivation and engagement in completing the proposed tasks. They will be asked to respond to a series of items concerning their interest in the activities, perceived competence, perceived effort, and the value they attribute to the task.
Measured: Day3
Box and Block Test
To assess gross manual dexterity and unilateral upper-limb function.The participant is asked to move as many small wooden blocks as possible from one compartment of a box to another within 60 seconds. The task is performed separately 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.
Measured: change between baseline (Day 1) and after training (Day 3)
Speed, Accuracy and Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot on a Reaching task and on a Drawing task
A simple Reaching task and a Drawing task (mandala) to assess motor control on the REAplan(R) robot
Measured: change between baseline (Day 1) and after training (Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start11 Aug 2026
- Primary completionSep 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Principal investigator, Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
- Investigators
- Yves Vandermeeren, MD,PhD, Principal investigator, UCLouvain IONS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822633
- Sponsor's protocol ID
- B039201938990 - part 5
- Acronym
- MLAS5
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Management Plan REDCap
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Brain Regions Critical for Human Motor Learning Through Anatomic-functional Correlations of Deficits in Acute Stroke: Integrated Robotic and Voxel-based Lesion Symptom Mapping Approach
- ClinicalTrials.gov ID
- NCT07822633
- Acronym / sponsor ID
- MLAS5 / B039201938990 - part 5
- Keywords
- Motor Skill Learning, Upper limb, Acute stroke, Rehabilitation, Inter-limb transfer, Subacute stroke, Chronic stroke, Robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether the improvements achieved through motor skill learning (MSkL) with the ipsilesional upper limb (UL) are transferred to the contralesional UL during the (sub)acute stroke phase, and to identify the neural substrates underlying this inter-limb transfer. To achieve this, healthy individuals, acute and chronic stroke patients will perform proximal and distal MSkL tasks using serious games implemented on robotic devices. This will be complemented by behavioural assessments and multimodal MRI.
Detailed description
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal MSkL.
Healthy individuals, acute and chronic stroke patients will be randomised equally to 2 different groups. One group of participants will train over the 3 days on the serious game Circuit on the REAplan® and the game Targeting on the Dextrain Manipulandum. The other one will only be assessed on day 1 and day 3 on the serious games and will not have any training.
For proximal upper limb with the serious game Circuit, the participants will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handle of the robot. A Reaching task and a Drawing task will be used to assess motor control.
For distal upper limb with the serious game Targeting, the participants will have to reach a series of targets with a cursor as quickly and accurately as possible by controlling their finger movements.
To explore the role of different brain structures in inter-limb transfer, 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 inter-limb transfer 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 this transfer.
Moreover, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipsilesional Group | Experimental | Device: REAplan®, Device: Dextrain Manipulandum®Participants will have trainings on the REAplan® robot using their ipsilesional arm with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device using their ipsilesional hand with a serious game based on distal MSkL. Participants will have assessment with each of their arms on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL |
| Control Group | Experimental | Device: REAplan®, Device: Dextrain Manipulandum®Participants will only have assessment with each of their arms but not trainings on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- First acute ischemic or hemorrhagic stroke
- Between the 2nd and 21st day post-stroke
- Age: 40-90 years
- Ability to complete the 3 consecutive sessions
- 40-90 years
Key exclusion criteria (21 listed)
- Stroke with multiple brain lesions
- Addiction (e.g., alcohol or drugs)
- Pregnancy
- Major cognitive impairment (e.g., depression, aphasia, dementia)
- Inability to perform or understand the required tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REAplan®motor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm | Device | Ipsilesional Group |
| Dextrain Manipulandum®motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand | Device | Ipsilesional Group |
| REAplan®proximal motor control and motor skill assessement with the REAplan® rehabilitation robot, to be performed by each arm | Device | Control Group, Ipsilesional Group |
| Dextrain Manipulandum®distal motor skill assessment with the Dextrain Manipulandum® dexterity tool to be performed by each hand | Device | Control Group, Ipsilesional Group |
Primary outcome
Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
force measured by the REAplan® robot
Time frame: change between baseline (Day 1) and after training (Day 3)
forces exerted in the wrong direction by each arm (Newtons)
Root Mean Square Error (RMSE) measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
error between the coordinates of the target and the cursor
Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
11 secondary outcomes
Hold time measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Coactivation measured by the Dextrain Manipulandum
Time frame: change between baseline (Day 1) and after training (Day 3)
Voxel-based Lesion Symptom Mapping (VLSM)
Time frame: Baseline
Diffusion Tensor Imaging (DTI)
Time frame: Baseline
Fugl Meyer Upper Extremity Test (FMA-UE)
Time frame: Day1
Oxford Cognitive Screen (OCS)
Time frame: Day2
Action Research Arm Test (ARAT)
Time frame: Day2
Fatigue Visual Analog Scale (VAS)
Time frame: Day 1
Intrinsic Motivation Inventory (IMI)
Time frame: Day3
Box and Block Test
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed, Accuracy and Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot on a Reaching task and on a Drawing task
Time frame: change between baseline (Day 1) and after training (Day 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. Data Management Plan REDCap
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wumeng Wang, MSc contact
Yves Vandermeeren, MD,PhD principal investigator
UCLouvain IONS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAplan® and Dextrain Manipulandum® in people with Stroke, Acute and Stroke (Subacute), 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 21 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 16 Sep 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?
Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot (time frame: change between baseline (Day 1) and after training (Day 3)). The study lists 4 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 16 Sep 2026.