REAplan®
Devicemotor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm
NCT Number: NCT07822633
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.
Interested in participating?
Request Info40 year–90 year
All sexes
Interventional
Not applicable
CHU UCL Namur, Yvoir, Namur, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
ACUTE STROKE PATIENTS:
Inclusion criteria
Exclusion criteria
HEALTHY INDIVIDUALS:
Inclusion criteria
Exclusion criteria
CHRONIC STROKE PATIENTS:
Inclusion criteria
Exclusion criteria
motor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm
motor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Time frame: change between baseline (Day 1) and after training (Day 3)
forces exerted in the wrong direction by each arm (Newtons)
Time frame: change between baseline (Day 1) and after training (Day 3)
error between the coordinates of the target and the cursor
Time frame: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Time frame: change between baseline (Day 1) and after training (Day 3)
The amount of time the cursor remains inside the target zone
Time frame: change between baseline (Day 1) and after training (Day 3)
binary measure of unasked fingers activated above the force threshold
Time frame: Baseline
Diffusion Weighted Imaging (DWI)
Time frame: Baseline
Fractional Anisotropy
Time frame: Day1
Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment.
Time frame: 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.
Time frame: Day2
evaluate upper-limb motor function and activity performance. Range: 0-57. higher scores indicating better upper-limb motor function
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Wumeng Wang, MSc
CONTACT
Yves Vandermeeren, MD, PhD
CONTACT
University Hospital of Mont-Godinne
Other
Identifying Brain Regions Critical for Human Motor Learning Through Anatomic-functional Correlations of Deficits in Acute Stroke: Integrated Robotic and Voxel-based Lesion Symptom Mapping Approach
Acronym: MLAS5
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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