Unimanual Versus Bimanual Motor Skill Learning in Acute and Chronic Stroke (MLAS6)
2026年9月14日 更新者：Pr Yves Vandermeeren, MD, PhD、University Hospital of Mont-Godinne
Comparison of Unimanual Versus Bimanual Motor Skill Learning (Proximal and Distal) After Stroke by Means of Robotics (REA²Plan® and Dextrain®) and Multimodal Brain Imaging (VLSM, DTI, NODDI, DIAMOND)
To test the capacity of healthy individuals, chronic and acute stroke patients to learn and retain a complex unimanual or bimanual motor skill, trained on the neurorehabiliation robot REAplan® et the Dextrain® device.
The goals are (1) to compare head-to-head bimanual versus unimanual motor learning (in the proximal and distal upper limb, UL) during the acute - early subactue stage of stroke with robotics and (2) to identify the neural substrates associated with (and deficits in) unimanual versus bimanual motor control (proximal and distal) after stroke by means of multimodal brain imaging.
研究概览
详细说明
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients (1) will be evaluated and (2) will train on the neurorehabiliation robot REAplan® and Dextrain® device.
They will practice a task on the robot REAplan® (unimanual or bimanual version), requiring movements with the affected arm (unimanual version) and complex, coordinated movements with both arms (bimanual version). They will practice another task on the Dextrain® device, also in unimanual and bimanual version.
In addition, several standardized clinical scales and tests will be used to evaluate overall motor-sensory-cognitive functions (clinical tests, questionnaires, ...)
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yves Vandermeeren, MD, PhD
- 电话号码：+32 (0)81 42 33 21
- 邮箱：yves.vandermereen@uclouvain.be
研究联系人备份
- 姓名：Laura Santelé, MSc
- 电话号码：+32 (0)81 42 34 91
- 邮箱：laura.santele@uclouvain.be
学习地点
-
-
Namur
-
Yvoir、Namur、比利时、5530
- 招聘中
- CHU UCL Namur
-
接触：
- Laura Santelé, MSc
- 电话号码：+32 (0)81 42 34 91
- 邮箱：laura.santele@uclouvain.be
-
接触：
- Yves Vandermeeren, MD, PhD
- 电话号码：+32 (0)81 42 33 21
- 邮箱：yves.vandermeeren@uclouvain.be
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
STROKE PATIENTS
Inclusion Criteria:
- acute stroke (between day 2 and day 21 post-stroke) or chronic stroke (>6 mois)
- aged 40-90 years
- with a single demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging
Exclusion Criteria:
- [for acute paitents] "classical" contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- difficulty in understanding or executing commands
- drug/alcohol abuse
- severe aphasia/cognitive deficits interfering with study
- inability to complete the tasks (i.e. full paralysis of the arm)
- multiple stroke/dementia/psychiatric condition
HEALTHY INDIVIDUALS
Inclusion Criteria:
- 40-90 years
Exclusion Criteria:
- "classical" contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- medical history with a previous stroke/relevant neurological deficit
- drug/alcohol abuse
- psychiatric condition/dementia
- having already used the robotic devices
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Bimanual tasks
Training on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the bimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a bimanual version of the Targeting task.
|
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
|
|
实验性的：Unimanual tasks
Training on the REAplan® robot with a serious game based on proximal motor skill learning (MSkL) with the unimanual version of the Circuit task and training on the Dextrain® Manipulandum with a serious game based on the distal MSkL with a unimanual version of the Targeting task.
|
motor skill learning with the REAplan® rehabilitation robot, to be performed with one or two arms
motor skill learning with the Dextrain® Manipulandum dexterity tool to be performed with on or two hands
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
bi-Force，由 REAplan® 机器人测量的双手力
大体时间：基线（第 1 天）和训练后（第 3 天）之间的变化
|
双手力，每只手臂在错误方向上施加的力（牛顿）
|
基线（第 1 天）和训练后（第 3 天）之间的变化
|
|
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
大体时间：Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode
|
Unimanual/bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy, in arbitrary units (SAT = speed (cm/s)/error (cm²).C, where C=1cm.s)
|
Change between baseline (Day 1) and after training (Day 3) and transfer from Day 3 to Day 1 on the untrained mode
|
|
bimanual Coordination factor (bi-CO) measured by the REAplan® robot
大体时间：change between baseline (Day 1) and after training (Day 3)
|
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both arms
|
change between baseline (Day 1) and after training (Day 3)
|
|
Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain® Manipulandum
大体时间：change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
|
tracking error between the optimal trajectory between 2 targets and the actual trajectory
|
change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
|
|
bimanual Coordination factor (bi-CO) measured by the Dextrain(R) Manipulandum
大体时间：change between baseline (Day 1) and after training (Day 3)
|
bimanual Coordination factor, mathematical measure of the phase coherence between speeds of both hands
|
change between baseline (Day 1) and after training (Day 3)
|
|
Hold time measured by the Dextrain® Manipulandum
大体时间：change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
|
The amount of time the cursor remains inside the target zone
|
change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
基于体素的病变症状映射 (VLSM)
大体时间：基线
|
扩散加权成像 (DWI)
|
基线
|
|
肩外展手指伸展 (SAFE) 测试
大体时间：第一天
|
中风后偏瘫上肢 (UL) 功能的预后决定因素。
对于 2 个子项中的每一个，范围是 0-5。
5 分表示正常功率。
分数为 0 表示不可能收缩。
|
第一天
|
|
修正的 Ashworth 量表 (mAS)
大体时间：第一天
|
痉挛的临床测量。
对于 8 个子项中的每一个，范围是 0-4。
分数越高意味着痉挛程度越高
|
第一天
|
|
Coactivation measured by the Dextrain Manipulandum
大体时间：change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
|
binary measure of unasked fingers activated above the force threshold
|
change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode
|
|
Diffusion Tensor Imaging (DTI)
大体时间：Baseline
|
Fractional Anisotrophy, Mean/Axial/Radial Diffusivity
|
Baseline
|
|
Fugl Meyer Upper Extremity (FMA-UE)
大体时间：Day1
|
Tests impairments of the upper limb after stroke.
Range: 0-66.
A higher score means less impairment
|
Day1
|
|
Box and Block test
大体时间：Day1
|
Measures unilateral gross dexterity by moving as many small wooden blocks as possible from one side to the other side of the box within 60 seconds.
The task is performed seperately with each hand.
Score range: 0-150 for each hand.
The score corresponds to the number of blocks successfully transferred in one minute.
A higher score indicates better gross manual dexterity and upper-limb function.
|
Day1
|
|
Purdue Pegboard Test
大体时间：Day1
|
Measures the fingertip dexterity and gross movement of the hand, fingers and arm.
4 different subtasks
|
Day1
|
|
Oxford Cognitive Screen
大体时间：Day2
|
A first-line, stroke-specific and domain-specific cognitive screening tool, inclusive for patients with aphasia and neglect.
Domains assessed: Language, Praxis, Number, Memory, Spatial and Controlled Attention.
It provides a cognitive profile showing both preserved and impaired abilities
|
Day2
|
|
Key WAIS IV
大体时间：Day2
|
A paper-pen test to asses processing speed and working memory.
|
Day2
|
|
Fatigue Visual Analog Scale
大体时间：Every days, mean of the three days
|
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.
A higher score means a higher level of fatigue.
|
Every days, mean of the three days
|
|
Intrinsic Motivation Inventory
大体时间：Day 3
|
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments
|
Day 3
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yves Vandermeeren, MD, PhD、UCLouvain IoNS
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月18日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2031年12月31日
研究注册日期
首次提交
2026年9月8日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- B039201938990 - part 6
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Data Management Plan REDCap
IPD 共享时间框架
The data will become available during the beginning of the study and for 10 years.
IPD 共享访问标准
Login user of the Hospital of CHU UCL Namur - Site Godinne
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.