Inter-Limb Transfer in Acute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorUniversity Hospital of Mont-Godinne
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Stroke with multiple brain lesions
Addiction (e.g., alcohol or drugs)
Pregnancy
Major cognitive impairment (e.g., depression, aphasia, dementia)
Trial design
Design model
Parallel
Treatments tested in this trial
REAplan®
Devicemotor skill learning with the REAplan® rehabilitation robot, to be performed with ipsilesional arm
Dextrain Manipulandum®
Devicemotor skill learning with the Dextrain Manipulandum® dexterity tool to be performed with ipsilesional hand
REAplan®
Deviceproximal motor control and motor skill assessement with the REAplan® rehabilitation robot, to be performed by each arm
Dextrain Manipulandum®
Devicedistal motor skill assessment with the Dextrain Manipulandum® dexterity tool to be performed by each hand
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Ipsilesional GroupExperimental treatment 2 interventions
Group B: Control GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot
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)2
force measured by the REAplan® robot
forces exerted in the wrong direction by each arm (Newtons)
Time frame
change between baseline (Day 1) and after training (Day 3)3
Root Mean Square Error (RMSE) measured by the Dextrain Manipulandum
error between the coordinates of the target and the cursor
Time frame
change between baseline (Day 1) and after training (Day 3)4
Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum
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)Secondary outcomes
1
Hold time measured by the Dextrain Manipulandum
The amount of time the cursor remains inside the target zone
Time frame
change between baseline (Day 1) and after training (Day 3)2
Coactivation measured by the Dextrain Manipulandum
binary measure of unasked fingers activated above the force threshold
Time frame
change between baseline (Day 1) and after training (Day 3)3
Voxel-based Lesion Symptom Mapping (VLSM)
Diffusion Weighted Imaging (DWI)
Time frame
Baseline4
Diffusion Tensor Imaging (DTI)
Fractional Anisotropy
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of Mont-Godinne
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborator
Source ClinicalTrials.gov