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

14 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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, ...)

Studietyp

Interventionell

Inskrivning (Beräknad)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: REAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
Enhet: Dextrain® Manipulandum
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
Experimentell: 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.
Enhet: REAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
Enhet: Dextrain® Manipulandum
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
bi-Force, bimanuell kraft mätt av REAplan®-roboten
Tidsram: byta mellan baslinje (dag 1) och efter träning (dag 3)
bimanuella krafter, krafter som utövas i fel riktning av varje arm (Newtons)
byta mellan baslinje (dag 1) och efter träning (dag 3)
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Voxel-baserad lesion Symptom Mapping (VLSM)
Tidsram: Baslinje
Diffusionsviktad bildbehandling (DWI)
Baslinje
Skulderbortförande fingerförlängningstest (SAFE).
Tidsram: Dag 1
En prognostisk bestämningsfaktor för funktionen hos den hemiparetiska övre extremiteten (UL) efter en stroke. För var och en av de 2 underposterna är intervallet 0-5. En poäng på 5 betyder normal effekt. En poäng på 0 betyder att ingen sammandragning är möjlig.
Dag 1
Modifierad Ashworth-skala (mAS)
Tidsram: Dag 1
kliniskt mått på spasticitet. För var och en av de 8 underposterna är intervallet 0-4. En högre poäng betyder en högre nivå av spasticitet
Dag 1
Coactivation measured by the Dextrain Manipulandum
Tidsram: 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)
Tidsram: Baseline
Fractional Anisotrophy, Mean/Axial/Radial Diffusivity
Baseline
Fugl Meyer Upper Extremity (FMA-UE)
Tidsram: Day1
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment
Day1
Box and Block test
Tidsram: 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
Tidsram: Day1
Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks
Day1
Oxford Cognitive Screen
Tidsram: 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
Tidsram: Day2
A paper-pen test to asses processing speed and working memory.
Day2
Fatigue Visual Analog Scale
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital of Mont-Godinne

Utredare

  • Huvudutredare: Yves Vandermeeren, MD, PhD, UCLouvain IoNS

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 maj 2026

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 december 2031

Studieregistreringsdatum

Först inskickad

8 september 2026

Först inskickad som uppfyllde QC-kriterierna

14 september 2026

Första postat (Faktisk)

17 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B039201938990 - part 6

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Data Management Plan REDCap

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

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