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NCT Number: NCT04642599

Bimanual Motor Skill Learning Through Robotics in Chronic Cerebellar Stroke Survivors and Healthy Individuals

To test capacity of chronic cerebellar stroke patients and healthy individuals to learn and retain a complex bimanual motor skill, trained on the neurorehabilitation robot REAplan® (bimanual version).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Cerebellar Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebellar Diseases Cerebrovascular Disorders Healthy Individuals (Controls) Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU UCL Namur, Mont-Godinne, Neurology Department, Stroke Unit

Yvoir, Namur, 5530, Belgium

About this study

Over 3 consecutive days, healthy individuals and chronic cerebellar stroke patients (1) will be evaluated and (2) will train on the neurorehabilitation robot REAplan®.

They will practice several tasks on the robot REAplan® (bimanual version), requiring either movements with the affected arm (unimanual tasks) or complex, coordinated movements with both arms (bimanual tasks).

In addition, several "classical" clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...).

Hand/digits motor function will be also evaluated with the kinetic device DexTrain®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

STROKE PATIENTS:

Inclusion criteria

  • having a chronic cerebellar stroke (>6 months)
  • aged 18-90 years
  • with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging

Exclusion criteria

  • difficulty in understanding or executing commands
  • drug/alcohol abuse
  • severe aphasia / cognitive deficits interfering with study
  • inability to voluntarily move the affected arm (i.e. complete paralysis of the arm)
  • multiple strokes / dementia / psychiatric condition

HEALTHY INDIVIDUALS:

Inclusion criteria

  • 18-90 years

Exclusion criteria

  • neurological conditions interfering with the study
  • drug/alcohol abuse
  • pyschiatric condition

Treatment and study plan

Bimanual motor skill learning with the REAplan® rehabilitation robot

Device

REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements

Primary outcomes

  1. Change in bi-SAT

    Time frame: Change between day 1 to 3

    Bimanual Speed/Accuracy Trade-off measured by the REAplan robot bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship bewteen speed and accuracy

  2. Change in bi-CO

    Time frame: Change between day 1 to 3

    Bimanual Coordination factor measured by the REAplan robot bimanual Coordination factor : mathematical measure of the phase coherence between velocities of both arms

Secondary outcomes

  1. bi-SAT

    Time frame: Day 1 + day 3

    On bimanual REACHING (REAplan robot) bimanual Speed/Accurady Trade-off: mathematical computation of the relationship

  2. bi-CO

    Time frame: Day 1 + day 3

    On bimanual REACHING (REAplan robot) bimanual Coordination factor: mathematical measure of the phase coherence between velocities of both arms

  3. change in bi-Force

    Time frame: Change between day 1 to 3

    Bimanual forces : forces exerted in the wrong direction by each arm (Newtons)

  4. bi-Force

    Time frame: Day 1 + day 3

    On bimanual REACHING (REAplan robot)

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

  5. bi-smoothness

    Time frame: Day 1+ day 3

    On bimanual REACHING (REAplan robot) Smoothness of movement : Spectral Arc Length (SPARC)

  6. bi-error

    Time frame: Day 1 + day 3

    on bimanual REACHING (REAplan robot) Error in centimeters or degrees during bimanual reaching

  7. Dextrain

    Time frame: Day 1 + day 3

    Kinetic device measuring the movements of each finger: error and co-activation (percentage)

  8. Dextrain

    Time frame: Day 1 + day 3

    Kinetic device measuring the movements of each finger: speed (milliseconds)

  9. Dextrain

    Time frame: Day 1 + day 3

    Kinetic device measuring the movements of each finger: force (Newton)

  10. BBT

    Time frame: Day 1 + day 3

    Box & Blocks Test (timed transfert of blocks from one space to the other)

  11. Modified International Cooperative Ataxia Rating Scale (MICARS)

    Time frame: Day 1

    Ataxia scale A high score describes strong ataxia and a low score describes weak ataxia

  12. Fugl Meyer Upper extremity test

    Time frame: Day 2

    Tests impairments of the upper limb after stroke

  13. Corsi block

    Time frame: Day 2

    Tests the visuo-spatial memory

  14. Montreal Cognitive Assessment (MoCA)

    Time frame: Day 2

    Tests the short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space

  15. Abilhand and activlim

    Time frame: Day 3

    Questionnaire about the bimanual hability during activities of the daily life

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Collaborators

  • Fonds National de la Recherche Scientifique
  • Louvain Bionics, UCLouvain
  • Université Catholique de Louvain

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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