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临床试验/NCT04642599
NCT04642599进行中(未招募)不适用

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

University Hospital of Mont-Godinne2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
2
主要终点
Change in bi-CO

研究概览

简要总结

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).

详细描述

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®.

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
None

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

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

Change in bi-CO

时间窗: 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

时间窗: 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

次要结局

  • bi-error(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)
  • Dextrain(Day 1 + 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

Professor

Université Catholique de Louvain

研究点 (2)

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