Exploring Motor Learning in Acute Stroke Through Robotics
ConditionStroke, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital of Mont-Godinne
About this trial
The acute phase of stroke is characterized by an enhancement of neural plasticity which supports rapid motor recovery. It is unclear whether acute stroke patients can acquire new motor skills with their affected upper limb. The aims of this research program are:
1. To test the capacity of acute stroke patients (\< 21 days) to learn and retain a complex unimanual motor skill. 2. To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning. 3. To compare acute stroke patients with healthy individuals and with chronic stroke patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
acute stroke (> 21 days)
aged 18-90 years
with a stroke lesion on brain imaging
Disqualifiers
" classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophoby, etc ...)
difficulty in understanding or executing commands
drug/alcohol abuse
severe aphasia / cognitive deficits interfering with study
Trial design
Design model
Parallel
Treatments tested in this trial
REAplan(R)
Devicemotor skill learning with the REAplan(R) rehabilitation robot, to be perfomed with the affected arm
Treatment groups
245 Participants
are divided into 3 treatment groupsGroup A: Motor Skill Learning (CIRCUIT)Experimental treatment 1 intervention
Group B: Motor control recovery (EASY)Active comparator 1 intervention
Group C: ConventionalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in SAT (CIRCUIT)
Speed/ Accuracy Trade-off
Time frame
change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)2
total distance travelled (EASY)
total distance travelled between the walls of the brick busters (in cm)
Time frame
change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)Secondary outcomes
1
Fugl Meyer Upper Extremity Test
Tests impairments of the upper limb after stroke
Time frame
change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)2
Arm Motor Ability (AMA) test
Measure disabilities of the upper limb after stroke
Time frame
change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)3
Fatigue Visual Analog Scale (VAS)
Visual Analog Scale to evaluate fatigue between 0 and 10. The maximum value (10) indicate a high level of fatiguability.
Time frame
change between Baseline Day1 and Day3 (acute) + between Baseline Day1 and 3/6 and 12 months post-stroke (subacute - chronic)4
Voxel-based Lesion Symptom Mapping (VLSM)
High-resolution 3D-MRI, diffusion MRI (DWI) \& perfusion MRI (PWI with Arterial SPin Labelling technique) will be acquired. The stroke areas will be drawn with MRIcron as volumes of interest (VOI) in native space and compared.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov