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Clinical Trials/NCT03974750
NCT03974750
Recruiting
Not Applicable

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

University Hospital of Mont-Godinne2 sites in 1 country100 target enrollmentJuly 1, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital of Mont-Godinne
Enrollment
100
Locations
2
Primary Endpoint
bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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).

Detailed Description

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, ...).

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
December 31, 2030
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

MD, PhD, Neurologist, Principal Investigator, Clinical Professor

University Hospital of Mont-Godinne

Eligibility Criteria

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:

Outcomes

Primary Outcomes

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

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)

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

Secondary Outcomes

  • bi-CO on bimanual REACHING (REAplan robot)(change between baseline (Day 1) and after training (Day 3))
  • bi-smoothness on bimanual REACHING (REAplan robot)(change between baseline (Day 1) and after training (Day 3))
  • BBT(change between baseline (Day 1) and after training (Day 3))
  • bi-error on bimanual REACHING (REAplan robot)(change between baseline (Day 1) and after training (Day 3))
  • bi-SAT on bimanual REACHING (REAplan robot)(change between baseline (Day 1) and after training (Day 3))
  • bi-Force on bimanual REACHING (REAplan robot)(change between baseline (Day 1) and after training (Day 3))
  • whole-hand GF(change between baseline (Day 1) and after training (Day 3))
  • Visual Analog Scale for fatigue (VAS fatigue)(change between baseline (Day 1) and after training (Day 3))

Study Sites (2)

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