Bimanual Motor Skill Learning in Acute Stroke

Stroke, Acute Clinical Trial

— MLAS4  

Official title:

Exploring the Neural Substrates of Proximal and Distal Bimanual Motor Skill Learning Through Robotics and Multimodal Brain Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760846
• Other study ID #: Bim-MSkL acute
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: October 2028

Study information

• Verified date: May 2023
• Source: University Hospital of Mont-Godinne
• Contact: Yves Vandermeeren, MD, PhD
• Phone: +32 81 42 33 21
• Email: yves.vandermeeren[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute
• Stroke, Subacute

Intervention

Device:
• REAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with both arms
• Dextrain Manipulandum®
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with both hands

Locations

Country	Name	City	State
Belgium	CHU UCL Namur	Yvoir	Namur
Belgium	University Hospital CHU Dinant Godinne UCL	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Reaction time measured by the Dextrain Manipulandum	time between the target appearance and when the force applied exceeds threshold	change between baseline (Day 1) and after training (Day 3)
Secondary	Rise time measured by the Dextrain Manipulandum	time between the reaction time and reaching the plateau	change between baseline (Day 1) and after training (Day 3)
Secondary	Coactivation measured by the Dextrain Manipulandum	binary measure of unasked fingers activated above the force threshold	change between baseline (Day 1) and after training (Day 3)
Secondary	Hold time measured by the Dextrain Manipulandum	time of plateau maintenance	change between baseline (Day 1) and after training (Day 3)
Secondary	Voxel-based Lesion Symptom Mapping (VLSM)	Diffusion Weighted Imaging (DWI)	Baseline
Secondary	Diffusion Tensor Imaging (DTI)	Fractional Anisotropy	Baseline
Secondary	Fugl Meyer Upper Extremity Test (FMA-UE)	Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment.	Day1
Secondary	Arm Motor Ability (AMA) test	Measure disabilities of the upper limb after stroke. Range: 0-100. A higher score means less disabilities in activities of daily living.	Day 1
Secondary	Montreal Cognitive Assessment (MoCA)	Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space. Range: 0-30, higher score means no cognitive impairment.	Day 1
Secondary	Fatigue Visual Analog Scale (VAS)	Visual Analog Scale to evaluate fatigue = a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Range : 0- 10. A higher score means a higher level of fatigue.	Day 1
Secondary	Shoulder Abduction Finger Extension (SAFE) test	A prognostic determinant of the function of the hemiparetic upper limb (UL) after a stroke. For each of the 2 subitems, the range is 0-5. A score of 5 means normal power. A score of 0 means no contraction possible.	Day 1
Secondary	Modified Ashworth Scale (mAS)	clinical measure of spasticity. For each of the 8 subitems, the range is 0-4. A higher score means a higher level of spasticity	Day 1