Clinical trial NCT05760846: Bimanual Motor Skill Learning in Acute Stroke
Official title: Exploring the Neural Substrates of Proximal and Distal Bimanual Motor Skill Learning Through Robotics and Multimodal Brain Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Stroke, Subacute
Keywords: Motor Skill Learning
Upper limb
Acute stroke
Rehabilitation
Subacute stroke
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: ACUTE STROKE PATIENTS:

Inclusion Criteria:

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

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:

Inclusion Criteria:

• 18-90 years

Exclusion Criteria:

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

Primary outcomes:
measure: bimanual Speed/Accuracy Trade-off (bi-SAT), bimanual Speed/Accuracy Trade-off measured by the REAplan® robot
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bimanual Coordination factor (bi-CO), bimanual Coordination factor measured by the REAplan® robot
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: bi-Force, bimanual force measured by the REAplan® robot
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain Manipulandum
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Bimanual Dexterity Coordination Index measured by the Dextrain Manipulandum
timeFrame: change between baseline (Day 1) and after training (Day 3)
Secondary outcomes:
measure: Reaction time measured by the Dextrain Manipulandum
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Rise time measured by the Dextrain Manipulandum
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Coactivation measured by the Dextrain Manipulandum
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Hold time measured by the Dextrain Manipulandum
timeFrame: change between baseline (Day 1) and after training (Day 3)
measure: Voxel-based Lesion Symptom Mapping (VLSM)
timeFrame: Baseline
measure: Diffusion Tensor Imaging (DTI)
timeFrame: Baseline
measure: Fugl Meyer Upper Extremity Test (FMA-UE)
timeFrame: Day1
measure: Arm Motor Ability (AMA) test
timeFrame: Day 1
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Day 1
measure: Fatigue Visual Analog Scale (VAS)
timeFrame: Day 1
measure: Shoulder Abduction Finger Extension (SAFE) test
timeFrame: Day 1
measure: Modified Ashworth Scale (mAS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU UCL Namur
state: Namur
city: Yvoir
country: Belgium
facility: University Hospital CHU Dinant Godinne UCL
Study officials:
affiliation: UCLouvain IONS
name: Yves Vandermeeren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: