Health TrialsbyHealthPanel

Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke

ConditionsAcute StrokeChronic Stroke PatientHealthy Individuals (Controls)Stroke (Subacute)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorUniversity Hospital of Mont-Godinne

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

[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

Trial design

Design model

Parallel

Treatments tested in this trial

  • REAplan®

    Device

    motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms

  • Dextrain® Manipulandum

    Device

    motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Bimanual tasksExperimental treatment 2 interventions
Group B: Unimanual tasksExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot

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)

Time frame
Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode
2

bimanual Coordination factor (bi-CO) measured by the REAplan® robot

bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms

Time frame
change between baseline (Day 1) and after training (Day 3)
3

bi-Force, bimanual force measured by the REAplan® robot

bimanual forces, forces exerted in the wrong direction by each arm (Newtons)

Time frame
change between baseline (Day 1) and after training (Day 3)
4

Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain® Manipulandum

tracking error between the optimal trajectory between 2 targets and the actual trajectory

Time frame
change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode

Secondary outcomes

1

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) and transfer between Day 3 and Day 1 on the untrained mode
2

Voxel-based Lesion Symptom Mapping (VLSM)

Diffusion Weighted Imaging (DWI)

Time frame
Baseline
3

Diffusion Tensor Imaging (DTI)

Fractional Anisotrophy, Mean/Axial/Radial Diffusivity

Time frame
Baseline
4

Fugl Meyer Upper Extremity (FMA-UE)

Tests impairments of the upper limb after stroke. Range: 0-66. A higher score means less impairment

Time frame
Day1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of Mont-Godinne

Lead sponsor

Source ClinicalTrials.gov
Apply now