Bimanual Motor Skill Learning in Acute Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REAplan®, Dextrain Manipulandum®.
- Who it may be relevant to
- Registry conditions: Stroke, Acute, Stroke, Subacute. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring the Neural Substrates of Proximal and Distal Bimanual Motor Skill Learning Through Robotics and Multimodal Brain Imaging
Overview
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.
Interventions
- Device REAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with both arms - Device Dextrain Manipulandum®
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with both hands
Primary outcome measures
- bimanual Speed/Accuracy Trade-off (bi-SAT), bimanual Speed/Accuracy Trade-off measured by the REAplan® robot [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bimanual Coordination factor (bi-CO), bimanual Coordination factor measured by the REAplan® robot [Time frame: change between baseline (Day 1) and after training (Day 3)]
- bi-Force, bimanual force measured by the REAplan® robot [Time frame: 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 [Time frame: change between baseline (Day 1) and after training (Day 3)]
- Bimanual Dexterity Coordination Index measured by the Dextrain Manipulandum [Time frame: change between baseline (Day 1) and after training (Day 3)]
Secondary outcome measures (12)
- Reaction time measured by the Dextrain Manipulandum [Time frame: change between baseline (Day 1) and after training (Day 3)]
- Rise time measured by the Dextrain Manipulandum [Time frame: change between baseline (Day 1) and after training (Day 3)]
- Coactivation measured by the Dextrain Manipulandum [Time frame: change between baseline (Day 1) and after training (Day 3)]
- Hold time measured by the Dextrain Manipulandum [Time frame: change between baseline (Day 1) and after training (Day 3)]
- Voxel-based Lesion Symptom Mapping (VLSM) [Time frame: Baseline]
- Diffusion Tensor Imaging (DTI) [Time frame: Baseline]
- Fugl Meyer Upper Extremity Test (FMA-UE) [Time frame: Day1]
- Arm Motor Ability (AMA) test [Time frame: Day 1]
- Montreal Cognitive Assessment (MoCA) [Time frame: Day 1]
- Fatigue Visual Analog Scale (VAS) [Time frame: Day 1]
- Shoulder Abduction Finger Extension (SAFE) test [Time frame: Day 1]
- Modified Ashworth Scale (mAS) [Time frame: Day 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Belgium · 2 centers
- CHU UCL Namur — Yvoir
- University Hospital CHU Dinant Godinne UCL — Yvoir
Identifiers
NCT: NCT05760846 · Bim-MSkL acute