Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke

NCT07826832 | Recruiting

• 1 other identifier: B039201938990 - part 6
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Stroke; Chronic Stroke Patient; Stroke (Subacute); Healthy Individuals (Controls)

Keywords

Motor Skill Learning; Upper Limb; Acute Stroke; Chronic Stroke; Rehabilitation; Subacute stroke; Robotics; MRI

Outcome Measures

Primary Outcomes (6)

• Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot

  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

  bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

  change between baseline (Day 1) and after training (Day 3)

• bi-Force, bimanual force measured by the REAplan® robot

  bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

  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

  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

  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

  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

Secondary Outcomes (12)

• Coactivation measured by the Dextrain Manipulandum

  change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode

• Voxel-based Lesion Symptom Mapping (VLSM)

  Baseline

• Diffusion Tensor Imaging (DTI)

  Baseline

• Fugl Meyer Upper Extremity (FMA-UE)

  Day1

• Box and Block test

  Day1

Study Arms (2)

Bimanual tasks

EXPERIMENTAL

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.

Device: REAplan®; Device: Dextrain® Manipulandum

Unimanual tasks

EXPERIMENTAL

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.

Device: REAplan®; Device: Dextrain® Manipulandum

Interventions

REAplan® DEVICE

motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms

Bimanual tasks; Unimanual tasks

Dextrain® Manipulandum DEVICE

motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands

Bimanual tasks; Unimanual tasks

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \[for acute paitents\] "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
• years
• "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

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (1)

CHU UCL Namur

Yvoir, Namur, 5530, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yves Vandermeeren, MD, PhD

  UCLouvain IoNS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Vandermeeren, MD, PhD

CONTACT

+32 (0)81 42 33 21; yves.vandermereen@uclouvain.be

Laura Santelé, MSc

CONTACT

+32 (0)81 42 34 91; laura.santele@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Neurologist, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 17, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available during the beginning of the study and for 10 years.
• Access Criteria: Login user of the Hospital of CHU UCL Namur - Site Godinne

Locations

BE (1)