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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
研究概览
简要总结
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.
详细描述
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •[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
研究组 & 干预措施
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.
干预措施: REAplan® (Device)
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.
干预措施: Dextrain® Manipulandum (Device)
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.
干预措施: REAplan® (Device)
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.
干预措施: Dextrain® Manipulandum (Device)
结局指标
主要结局
Unimanual/bimanual Speed/Accuracy Trade-off (SAT/bi-SAT) measured by the REAplan® robot
时间窗: 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)
bimanual Coordination factor (bi-CO) 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
bi-Force, bimanual force 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)
Root Mean Square Error (RMSE), bimanual root mean square error measured by the Dextrain® Manipulandum
时间窗: 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
bimanual Coordination factor (bi-CO) measured by the Dextrain(R) Manipulandum
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 hands
Hold time measured by the Dextrain® Manipulandum
时间窗: 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
次要结局
- Coactivation measured by the Dextrain Manipulandum(change between baseline (Day 1) and after training (Day 3) and transfer between Day 3 and Day 1 on the untrained mode)
- Voxel-based Lesion Symptom Mapping (VLSM)(Baseline)
- Diffusion Tensor Imaging (DTI)(Baseline)
- Fugl Meyer Upper Extremity (FMA-UE)(Day1)
- Box and Block test(Day1)
- Purdue Pegboard Test(Day1)
- Oxford Cognitive Screen(Day2)
- Key WAIS IV(Day2)
- Fatigue Visual Analog Scale(Every days, mean of the three days)
- Shoulder Abduction Finger Extension (SAFE) test(Day 1)
- Modified Ashworth Scale (mAS)(Day 1)
- Intrinsic Motivation Inventory(Day 3)
研究者
Pr Yves Vandermeeren, MD, PhD
MD, PhD, Neurologist, Principal Investigator, Clinical Professor
University Hospital of Mont-Godinne