Bimanual Motor Skill Learning in Acute Stroke

NCT ID: NCT05760846

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2028-10-31

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.

Detailed Description

Over 3 consecutive days, the patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal bim-MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal bim-MSkL.

For proximal bim-MSkL, patients will train over the 3 days on the serious game Circuit on the bimanual REAplan® and will be randomised to two different bimanual versions. By this means, the investigators will explore the components of bim-MSkL in acute stroke patients.

The motor skill learning setup (Circuit) that was developed and successfully used in healthy individuals and stroke patients has already been implemented in the REAplan® environment and will be used as innovative serious games based on a speed/accuracy trade-off (SAT), allowing a detailed analysis of motor skill learning components (speed, accuracy, SAT, movement smoothness, dynamics...). For the serious game Circuit, who based on motor skill learning, the subjects will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handles of the robot with both arms.

For distal bim-MSkL, patients will train on a complex sequence of finger movements involving both hands. Each day, several successive repetitions of the sequence will be displayed, corresponding to one block. 3 to 6 blocks will be repeated, each separated by 30 sec of rest. After training on the third day, a new sequence will be repeated for 3 blocks to assess generalization.

To explore the role of different brain structures in bim-MskL, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and proximal/distal bim-MskL scores on a voxel-by-voxel basis.

Diffusion Tensor Imaging (DTI) will quantify the integrity of several white matter tracts, allowing through correlation analyses to unveil the white matter tracts crucial to achieve proximal and/or distal bim-MskL.

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.

In addition to the (sub)acute stroke patients, a group of healthy individuals who will not undergo MRI (n=60) will be enrolled as control group. Subjects in this group will also be randomized 1/1 in the two versions of the bimanual Circuit task on the REAplan® robot.

Conditions

Stroke, Acute; Stroke, Subacute

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Bimanual Circuit version 1

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

Group Type: EXPERIMENTAL

REAplan®

Intervention Type: DEVICE

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

Dextrain Manipulandum®

Intervention Type: DEVICE

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

Bimanual Circuit version 2

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

Group Type: EXPERIMENTAL

REAplan®

Intervention Type: DEVICE

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

Dextrain Manipulandum®

Intervention Type: DEVICE

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

Interventions

REAplan®

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

Intervention Type: DEVICE

Dextrain Manipulandum®

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 18-90 years

Exclusion Criteria

• " 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:

• medical history with a previous stroke / relevant neurological deficit
• drug/alcohol abuse
• psychiatric condition/ dementia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of Mont-Godinne

OTHER

Sponsor Role: lead

Responsible Party

Pr Yves Vandermeeren, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yves Vandermeeren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLouvain IONS

Locations

CHU UCL Namur

Yvoir, Namur, Belgium

Site Status: RECRUITING

University Hospital CHU Dinant Godinne UCL

Yvoir, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Yves Vandermeeren, MD, PhD

Role: CONTACT

Phone: +32 81 42 33 21

Email: yves.vandermeeren@uclouvain.be

Coralie van Ravestyn, MSc

Role: CONTACT

Phone: +32 81 34 06

Email: coralie.vanravestyn@uclouvain.be

Facility Contacts

Coralie van Ravestyn

Role: primary

Yves Vandermeeren, MD, PhD

Role: primary

Other Identifiers

Bim-MSkL acute

Identifier Type: -

Identifier Source: org_study_id