Inter-Limb Transfer in Acute Stroke

NCT07822633 | Recruiting

• 1 other identifier: B039201938990 - part 5
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Stroke, Acute; Stroke (Subacute); Healthy Individuals (Controls); Chronic Stroke Patients

Keywords

Motor Skill Learning; Upper limb; Acute stroke; Rehabilitation; Inter-limb transfer; Subacute stroke; Chronic stroke; Robotics

Outcome Measures

Primary Outcomes (4)

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

  Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy

  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)

  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

  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

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

Secondary Outcomes (11)

• Hold time measured by the Dextrain Manipulandum

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

• Coactivation measured by the Dextrain Manipulandum

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

• Voxel-based Lesion Symptom Mapping (VLSM)

  Baseline

• Diffusion Tensor Imaging (DTI)

  Baseline

• Fugl Meyer Upper Extremity Test (FMA-UE)

  Day1

Study Arms (2)

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

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

Device: REAplan®; Device: Dextrain Manipulandum®

Interventions

REAplan® DEVICE

motor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm

Ipsilesional Group

Dextrain Manipulandum® DEVICE

motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand

Ipsilesional Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
• HEALTHY INDIVIDUALS:
• years
• availability to complete three consecutive sessions.
• "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

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (2)

CHU UCL Namur

Yvoir, Namur, 5530, Belgium

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, 1200, 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 81 42 33 21; yves.vandermeeren@uclouvain.be

Wumeng Wang, MSc

CONTACT

wumeng.wang@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Not aware being of the different versions of the tasks
• 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 10, 2026
• First Posted: September 16, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: September 16, 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, Login user of the Hospital of Cliniques universitaires Saint-Luc

Locations

BE (2)