Acute Stroke, Chronic Stroke Patient, Healthy Individuals (Controls), Stroke (Subacute)
Conditions
Keywords
Motor Skill Learning, Upper Limb, Acute Stroke, Chronic Stroke, Rehabilitation, Subacute stroke, Robotics, MRI
Brief summary
To test the capacity of healthy individuals, chronic and acute stroke patients to learn and retain a complex unimanual or bimanual motor skill, trained on the neurorehabiliation robot REAplan® et the Dextrain® device. The goals are (1) to compare head-to-head bimanual versus unimanual motor learning (in the proximal and distal upper limb, UL) during the acute - early subactue stage of stroke with robotics and (2) to identify the neural substrates associated with (and deficits in) unimanual versus bimanual motor control (proximal and distal) after stroke by means of multimodal brain imaging.
Detailed description
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabiliation robot REAplan® and Dextrain® device. They will practice a task on the robot REAplan® (unimanual or bimanual version), requiring movements with the affected arm (unimanual version) and complex, coordinated movements with both arms (bimanual version). They will practice another task on the Dextrain® device, also in unimanual and bimanual version. In addition, several standardized clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...)
Interventions
DEVICEREAplan®
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
DEVICEDextrain® Manipulandum
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
Sponsors
University Hospital of Mont-Godinne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
STROKE PATIENTS Inclusion Criteria: * acute stroke (between day 2 and day 21 post-stroke) or chronic stroke (\>6 mois) * aged 40-90 years * with a single demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
Exclusion criteria
* \[for acute paitents\] "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 stroke/dementia/psychiatric condition HEALTHY INDIVIDUALS Inclusion Criteria: * 40-90 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot | Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode | Unimanual/bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy, in arbitrary units (SAT = speed (cm/s)/error (cm²).C, where C=1cm.s) |
| bimanual Coordination factor (bi-CO) measured by the REAplan® robot | change between baseline (Day 1) and after training (Day 3) | bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms |
| bi-Force, bimanual force measured by the REAplan® robot | change between baseline (Day 1) and after training (Day 3) | bimanual forces, forces exerted in the wrong direction by each arm (Newtons) |
| Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain® Manipulandum | change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode | tracking error between the optimal trajectory between 2 targets and the actual trajectory |
| bimanual Coordination factor (bi-CO) measured by the Dextrain(R) Manipulandum | change between baseline (Day 1) and after training (Day 3) | bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both hands |
| Hold time measured by the Dextrain® Manipulandum | change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode | The amount of time the cursor remains inside the target zone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coactivation measured by the Dextrain Manipulandum | change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode | 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 Anisotrophy, Mean/Axial/Radial Diffusivity |
| Fugl Meyer Upper Extremity (FMA-UE) | Day1 | Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment |
| Box and Block test | Day1 | Measures unilateral gross dexterity by moving as many small wooden blocks as possible from one side to the other side of the box within 60 seconds. The task is performed seperately 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. |
| Purdue Pegboard Test | Day1 | Measures the fingertip dexterity and gross movement of the hand, fingers and arm. 4 different subtasks |
| Oxford Cognitive Screen | Day2 | A first-line, stroke-specific and domain-specific cognitive screening tool, inclusive for patients with aphasia and neglect. Domains assessed: Language, Praxis, Number, Memory, Spatial and Controlled Attention. It provides a cognitive profile showing both preserved and impaired abilities |
| Key WAIS IV | Day2 | A paper-pen test to asses processing speed and working memory. |
| Fatigue Visual Analog Scale | Every days, mean of the three days | 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. |
| Shoulder Abduction Finger Extension (SAFE) test | Day 1 | 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. |
| Modified Ashworth Scale (mAS) | Day 1 | clinical measure of spasticity. For each of the 8 subitems, the range is 0-4. A higher score means a higher level of spasticity |
| Intrinsic Motivation Inventory | Day 3 | The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments |
Countries
Belgium
Contacts
CONTACTYves Vandermeeren, MD, PhD
CONTACTLaura Santelé, MSc
PRINCIPAL_INVESTIGATORYves Vandermeeren, MD, PhD
UCLouvain IoNS
Outcome results
None listed