Bimanual Motor Skill Learning in Acute Stroke

NCT05760846 | Recruiting

• 1 other identifier: Bim-MSkL acute
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute; Stroke, Subacute

Keywords

Motor Skill Learning; Upper limb; Acute stroke; Rehabilitation; Subacute 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

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 1; Bimanual Circuit version 2

Dextrain Manipulandum® DEVICE

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

Bimanual Circuit version 1; Bimanual Circuit version 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

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 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

Coralie van Ravestyn, MSc

CONTACT

+32 81 34 06; coralie.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
• 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)