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Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke (MLAS6)

14. september 2026 opdateret af: Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne

Comparison of Unimanual Versus Bimanual Motor Skill Learning (Proximal and Distal) After Stroke by Means of Robotics (REA²Plan® and Dextrain®) and Multimodal Brain Imaging (VLSM, DTI, NODDI, DIAMOND)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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, ...)

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

STROKE PATIENTS

Inclusion Criteria:

  • acute stroke (between day 2 and day 21 post-stroke) or chronic stroke (>6 mois)
  • aged 40-90 years
  • with a single demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging

Exclusion Criteria:

  • [for acute paitents] "classical" contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
  • difficulty in understanding or executing commands
  • drug/alcohol abuse
  • severe aphasia/cognitive deficits interfering with study
  • inability to complete the tasks (i.e. full paralysis of the arm)
  • multiple stroke/dementia/psychiatric condition

HEALTHY INDIVIDUALS

Inclusion Criteria:

  • 40-90 years

Exclusion Criteria:

  • "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
  • drug/alcohol abuse
  • psychiatric condition/dementia
  • having already used the robotic devices

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Bimanual tasks
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.
Enhed: REAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
Enhed: Dextrain® Manipulandum
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
Eksperimentel: Unimanual tasks
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.
Enhed: REAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
Enhed: Dextrain® Manipulandum
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
bi-Force, bimanuel kraft målt af REAplan®-robotten
Tidsramme: skift mellem baseline (dag 1) og efter træning (dag 3)
bimanuelle kræfter, kræfter udøvet i den forkerte retning af hver arm (Newtons)
skift mellem baseline (dag 1) og efter træning (dag 3)
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
Tidsramme: Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode
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)
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
Tidsramme: change between baseline (Day 1) and after training (Day 3)
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms
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
Tidsramme: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
tracking error between the optimal trajectory between 2 targets and the actual trajectory
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
Tidsramme: change between baseline (Day 1) and after training (Day 3)
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both hands
change between baseline (Day 1) and after training (Day 3)
Hold time measured by the Dextrain® Manipulandum
Tidsramme: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
The amount of time the cursor remains inside the target zone
change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Voxel-baseret læsion Symptom Mapping (VLSM)
Tidsramme: Baseline
Diffusionsvægtet billeddannelse (DWI)
Baseline
Skulder Abduction Finger Extension (SAFE) test
Tidsramme: Dag 1
En prognostisk determinant for funktionen af ​​den hemiparetiske øvre ekstremitet (UL) efter et slagtilfælde. For hver af de 2 underpunkter er intervallet 0-5. En score på 5 betyder normal effekt. En score på 0 betyder, at ingen sammentrækning er mulig.
Dag 1
Modificeret Ashworth-skala (mAS)
Tidsramme: Dag 1
kliniske mål for spasticitet. For hver af de 8 underpunkter er intervallet 0-4. En højere score betyder et højere niveau af spasticitet
Dag 1
Coactivation measured by the Dextrain Manipulandum
Tidsramme: change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
binary measure of unasked fingers activated above the force threshold
change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
Diffusion Tensor Imaging (DTI)
Tidsramme: Baseline
Fractional Anisotrophy, Mean/Axial/Radial Diffusivity
Baseline
Fugl Meyer Upper Extremity (FMA-UE)
Tidsramme: Day1
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment
Day1
Box and Block test
Tidsramme: Day1
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.
Day1
Purdue Pegboard Test
Tidsramme: Day1
Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks
Day1
Oxford Cognitive Screen
Tidsramme: Day2
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
Day2
Key WAIS IV
Tidsramme: Day2
A paper-pen test to asses processing speed and working memory.
Day2
Fatigue Visual Analog Scale
Tidsramme: Every days, mean of the three days
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.
Every days, mean of the three days
Intrinsic Motivation Inventory
Tidsramme: Day 3
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments
Day 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital of Mont-Godinne

Efterforskere

  • Ledende efterforsker: Yves Vandermeeren, MD, PhD, UCLouvain IoNS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. maj 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

8. september 2026

Først indsendt, der opfyldte QC-kriterier

14. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B039201938990 - part 6

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data Management Plan REDCap

IPD-delingstidsramme

The data will become available during the beginning of the study and for 10 years.

IPD-delingsadgangskriterier

Login user of the Hospital of CHU UCL Namur - Site Godinne

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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