Chronic Stroke Patients, Healthy Individuals (Controls), Stroke, Acute, Stroke (Subacute)
Conditions
Keywords
Motor Skill Learning, Upper limb, Acute stroke, Rehabilitation, Inter-limb transfer, Subacute stroke, Chronic stroke, Robotics
Brief summary
This study aims to investigate whether the improvements achieved through motor skill learning (MSkL) with the ipsilesional upper limb (UL) are transferred to the contralesional UL during the (sub)acute stroke phase, and to identify the neural substrates underlying this inter-limb transfer. To achieve this, healthy individuals, acute and chronic stroke patients will perform proximal and distal MSkL tasks using serious games implemented on robotic devices. This will be complemented by behavioural assessments and multimodal MRI.
Detailed description
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal MSkL. Healthy individuals, acute and chronic stroke patients will be randomised equally to 2 different groups. One group of participants will train over the 3 days on the serious game Circuit on the REAplan® and the game Targeting on the Dextrain Manipulandum. The other one will only be assessed on day 1 and day 3 on the serious games and will not have any training. For proximal upper limb with the serious game Circuit, the participants will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handle of the robot. A Reaching task and a Drawing task will be used to assess motor control. For distal upper limb with the serious game Targeting, the participants will have to reach a series of targets with a cursor as quickly and accurately as possible by controlling their finger movements. To explore the role of different brain structures in inter-limb transfer, 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 inter-limb transfer 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 this transfer. Moreover, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions.
Interventions
DEVICEREAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm
DEVICEDextrain Manipulandum®
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand
Sponsors
University Hospital of Mont-Godinne
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Not aware being of the different versions of the tasks
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
ACUTE STROKE PATIENTS: Inclusion Criteria: * First acute ischemic or hemorrhagic stroke * Between the 2nd and 21st day post-stroke * Age: 40-90 years * Ability to complete the 3 consecutive sessions
Exclusion criteria
* Stroke with multiple brain lesions * Addiction (e.g., alcohol or drugs) * Pregnancy * Major cognitive impairment (e.g., depression, aphasia, dementia) * Inability to perform or understand the required tasks * Uncontrolled health conditions * " classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...) HEALTHY INDIVIDUALS: Inclusion Criteria: * 40-90 years * availability to complete three consecutive sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot | change between baseline (Day 1) and after training (Day 3) | Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy |
| force measured by the REAplan® robot | change between baseline (Day 1) and after training (Day 3) | forces exerted in the wrong direction by each arm (Newtons) |
| Root Mean Square Error (RMSE) measured by the Dextrain Manipulandum | change between baseline (Day 1) and after training (Day 3) | error between the coordinates of the target and the cursor |
| Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum | change between baseline (Day 1) and after training (Day 3) | Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hold time measured by the Dextrain Manipulandum | change between baseline (Day 1) and after training (Day 3) | The amount of time the cursor remains inside the target zone |
| Coactivation measured by the Dextrain Manipulandum | change between baseline (Day 1) and after training (Day 3) | binary measure of unasked fingers activated above the force threshold |
| Voxel-based Lesion Symptom Mapping (VLSM) | Baseline | Diffusion Weighted Imaging (DWI) |
| Diffusion Tensor Imaging (DTI) | Baseline | Fractional Anisotropy |
| Fugl Meyer Upper Extremity Test (FMA-UE) | Day1 | Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment. |
| Oxford Cognitive Screen (OCS) | Day2 | to identify cognitive impairments following stroke. Rather than providing only a single overall cognitive score, the OCS assesses several distinct cognitive domains (Language, Praxis, Number, Memory, Spatial and Controlled Attention) and produces a cognitive profile showing both preserved and impaired abilities. |
| Action Research Arm Test (ARAT) | Day2 | evaluate upper-limb motor function and activity performance. Range: 0-57. higher scores indicating better upper-limb motor function |
| Fatigue Visual Analog Scale (VAS) | Day 1 | 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. |
| Intrinsic Motivation Inventory (IMI) | Day3 | To assess participants' level of motivation and engagement in completing the proposed tasks. They will be asked to respond to a series of items concerning their interest in the activities, perceived competence, perceived effort, and the value they attribute to the task. |
| Box and Block Test | change between baseline (Day 1) and after training (Day 3) | To assess gross manual dexterity and unilateral upper-limb function.The participant is asked to move as many small wooden blocks as possible from one compartment of a box to another within 60 seconds. The task is performed separately with each hand. Score range: 0-150 for each hand. The score corresponds to the number of blocks successfully transferred in one minute. A higher score indicates better gross manual dexterity and upper-limb function. |
| Speed, Accuracy and Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot on a Reaching task and on a Drawing task | change between baseline (Day 1) and after training (Day 3) | A simple Reaching task and a Drawing task (mandala) to assess motor control on the REAplan(R) robot |
Countries
Belgium
Contacts
CONTACTYves Vandermeeren, MD, PhD
CONTACTWumeng Wang, MSc
PRINCIPAL_INVESTIGATORYves Vandermeeren, MD,PhD
UCLouvain IONS
Outcome results
None listed