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Clinical Trials/NCT04642599
NCT04642599
Active, not recruiting
Not Applicable

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

University Hospital of Mont-Godinne1 site in 1 country50 target enrollmentJanuary 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Cerebellar Stroke
Sponsor
University Hospital of Mont-Godinne
Enrollment
50
Locations
1
Primary Endpoint
Change in bi-CO
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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).

Detailed Description

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®.

Registry
clinicaltrials.gov
Start Date
January 29, 2021
End Date
December 31, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital of Mont-Godinne
Responsible Party
Principal Investigator
Principal Investigator

Pr Yves Vandermeeren, MD, PhD

Professor

Université Catholique de Louvain

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • bi-error(Day 1 + day 3)
  • Dextrain(Day 1 + day 3)
  • change in bi-Force(Change between day 1 to 3)
  • bi-smoothness(Day 1+ day 3)
  • Corsi block(Day 2)
  • Montreal Cognitive Assessment (MoCA)(Day 2)
  • bi-Force(Day 1 + day 3)
  • Abilhand and activlim(Day 3)
  • bi-SAT(Day 1 + day 3)
  • bi-CO(Day 1 + day 3)
  • BBT(Day 1 + day 3)
  • Modified International Cooperative Ataxia Rating Scale (MICARS)(Day 1)
  • Fugl Meyer Upper extremity test(Day 2)

Study Sites (1)

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