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NCT Number: NCT03974750

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases 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, Belgium

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About this study

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

They will practice several tasks on the robot REAplan (R) (bimanual version), requiring either movements with the affected arm (unimanual tasks) and 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, ...).

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 stroke (>6 months)
  • aged 18-90 years
  • with demonstrate a stroke 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
  • botulinum toxin injections (to be evaluated)

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(R) rehabilitation robot

Device

REAplan(R) rehabilitation robot : training to perform complex, coordinated, bimanual movements

Primary outcomes

  1. bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot

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

    bimanual Speed/Accurady Trade-off: mathematical computation of the relationship bewteen speed and accuracy

  2. bi-CO, bimanual Coordination factor measured by the REAplan robot

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

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

  3. bi-Force, bimanual Coordination factor measured by the REAplan robot

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

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

Secondary outcomes

  1. bi-SAT on bimanual REACHING (REAplan robot)

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

    bimanual Speed/Accurady Trade-off: mathematical computation of the relationship

  2. bi-Force on bimanual REACHING (REAplan robot)

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

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

  3. bi-CO on bimanual REACHING (REAplan robot)

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

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

  4. bi-smoothness on bimanual REACHING (REAplan robot)

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

    Smoothness of movement : Spectral Arc Length (SPARC)

  5. bi-error on bimanual REACHING (REAplan robot)

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

    Error in centimeres or degrees during bimanual reaching

  6. BBT

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

    Box & Blocks Test (timed transfert of blocks from one space to the other, 3 trials/hand)

  7. whole-hand GF

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

    whole-hand Grip Force (GF) measured with a dynamometer, 3 trials/hand)

  8. Visual Analog Scale for fatigue (VAS fatigue)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yves Vandermeeren, MD, PhD

CONTACT

[email protected]

+3281423321

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Collaborators

  • Université Catholique de Louvain

Registry information

Acronym: bimMsKL

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Jun 5, 2019
Registry last updated
Apr 3, 2025

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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