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临床试验/NCT03974750
NCT03974750招募中不适用

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

University Hospital of Mont-Godinne3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
3
主要终点
bi-SAT, bimanual Speed/Accurady Trade-off measured by the REAplan robot

研究概览

简要总结

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).

详细描述

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, ...).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • STROKE PATIENTS :
  • Inclusion Criteria:
  • having a chronic stroke (>6 months)
  • aged 18-90 years
  • with demonstrate a stroke lesion on brain imaging.

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: change between baseline (Day 1) and after training (Day 3)

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

次要结局

  • 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))

研究者

发起方
University Hospital of Mont-Godinne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr Yves Vandermeeren, MD, PhD

MD, PhD, Neurologist, Principal Investigator, Clinical Professor

University Hospital of Mont-Godinne

研究点 (3)

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