NCT05760846

Brief Summary

The subacute phase of stroke provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. The recovery from motor impairment has been extensively studied, but it is currently unknown whether motor skill learning (MSkL) is enhanced or impaired during acute stroke, especially bimanual motor skill learning (bim-MSkL), which likely requires more motor-attentional-cognitive resources than unimanual MSkL. The goals of this project are: to determine the neural substrates critical to achieve proximal and distal bimanual motor skill learning (bim-MSkL) by specifying whether (sub)acute stroke to different brain areas (cortical and subcortical) induce specific deficits in bimanual and/or distal bim-MSkL, which behavioral components are involved in bim-MSkL, and whether damage to the motor, sensory and inter-hemispheric pathways specifically impairs proximal and/or distal bim-MSkL.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Apr 2023Oct 2028

First Submitted

Initial submission to the registry

February 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

4.9 years

First QC Date

February 22, 2023

Last Update Submit

December 10, 2024

Conditions

Stroke, AcuteStroke, Subacute

Keywords

Motor Skill LearningUpper limbAcute strokeRehabilitationSubacute stroke

Outcome Measures

Primary Outcomes (5)

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

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

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

  • bimanual Coordination factor (bi-CO), bimanual Coordination factor 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 actual applied force and the target force

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

  • Bimanual Dexterity Coordination Index measured by the Dextrain Manipulandum

    bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both thumb-index clamps

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

Secondary Outcomes (12)

  • Reaction time measured by the Dextrain Manipulandum

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

  • Rise 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)

  • Hold time measured by the Dextrain Manipulandum

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

  • Voxel-based Lesion Symptom Mapping (VLSM)

    Baseline

  • +7 more secondary outcomes

Study Arms (2)

Bimanual Circuit version 1

EXPERIMENTAL

Training on the REAplan® robot with a serious game based on proximal motor skill learning (bim-MSkL) with the bimanual version 1 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL

Device: REAplan®Device: Dextrain Manipulandum®

Bimanual Circuit version 2

EXPERIMENTAL

Training on the REAplan® robot with a serious game based on motor skill learning (MSkL) with bimanual version 2 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL

Device: REAplan®Device: Dextrain Manipulandum®

Interventions

REAplan®DEVICE

motor skill learning with the REAplan® rehabilitation robot, to be performed with both arms

Bimanual Circuit version 1Bimanual Circuit version 2
Dextrain Manipulandum®DEVICE

motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with both hands

Bimanual Circuit version 1Bimanual Circuit version 2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute stroke (\< 21 days)
  • aged 18-90 years
  • with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging

You may not qualify if:

  • " 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 strokes / dementia / psychiatric condition
  • HEALTHY INDIVIDUALS:
  • 18-90 years
  • medical history with a previous stroke / relevant neurological deficit
  • drug/alcohol abuse
  • psychiatric condition/ dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU UCL Namur

Yvoir, Namur, 5530, Belgium

RECRUITING

University Hospital CHU Dinant Godinne UCL

Yvoir, 5530, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yves Vandermeeren, MD, PhD

    UCLouvain IONS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Vandermeeren, MD, PhD

CONTACT

+32 81 42 33 21yves.vandermeeren@uclouvain.be

Coralie van Ravestyn, MSc

CONTACT

+32 81 34 06coralie.vanravestyn@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
Principal Investigator

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 8, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Data Management Plan REDCap

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available during the beginning of the study and for 20 years.
Access Criteria
Login user of the Hospital of CHU UCL Namur -Site Godinne

Locations

BE(2)