Identifying Brain Regions Critical for Human Motor Learning Through Anatomic-functional Correlations of Deficits in Acute Stroke: Integrated Robotic and Voxel-based Lesion Symptom Mapping Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum
研究概览
简要总结
This study aims to investigate whether the improvements achieved through motor skill learning (MSkL) with the ipsilesional upper limb (UL) are transferred to the contralesional UL during the (sub)acute stroke phase, and to identify the neural substrates underlying this inter-limb transfer. To achieve this, healthy individuals, acute and chronic stroke patients will perform proximal and distal MSkL tasks using serious games implemented on robotic devices. This will be complemented by behavioural assessments and multimodal MRI.
详细描述
Over 3 consecutive days, healthy individuals, acute and chronic stroke patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal MSkL.
Healthy individuals, acute and chronic stroke patients will be randomised equally to 2 different groups. One group of participants will train over the 3 days on the serious game Circuit on the REAplan® and the game Targeting on the Dextrain Manipulandum. The other one will only be assessed on day 1 and day 3 on the serious games and will not have any training.
For proximal upper limb with the serious game Circuit, the participants will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handle of the robot. A Reaching task and a Drawing task will be used to assess motor control.
For distal upper limb with the serious game Targeting, the participants will have to reach a series of targets with a cursor as quickly and accurately as possible by controlling their finger movements.
To explore the role of different brain structures in inter-limb transfer, Voxel-based Lesion Symptom Mapping (VLSM) based on high-resolution brain magnetic resonance imaging (MRI) scans, will be used to analyse the relationship between tissue damage and inter-limb transfer scores on a voxel-by-voxel basis.
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)
盲法说明
Not aware being of the different versions of the tasks
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
- •ACUTE STROKE PATIENTS:
- •Inclusion Criteria:
- •First acute ischemic or hemorrhagic stroke
- •Between the 2nd and 21st day post-stroke
- •Age: 40-90 years
- •Ability to complete the 3 consecutive sessions
排除标准
- •Stroke with multiple brain lesions
- •Addiction (e.g., alcohol or drugs)
- •Pregnancy
- •Major cognitive impairment (e.g., depression, aphasia, dementia)
- •Inability to perform or understand the required tasks
- •Uncontrolled health conditions
- •" classical " contre-indication to MRI (non-MR-compatible pacemaker, pregnancy, non-MR-compatible implanted devices, claustrophobia, etc ...)
- •HEALTHY INDIVIDUALS:
- •Inclusion Criteria:
- •40-90 years
- •availability to complete three consecutive sessions.
- •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 or disease
- •drug/alcohol abuse
- •psychiatric condition/dementia
- •having already used the robotic devices
- •CHRONIC STROKE PATIENTS:
- •Inclusion Criteria:
- •single stroke confirmed by brain imaging
- •time since stroke onset >6 months
- •age between 40-90 years
- •availability to complete three consecutive sessions.
- •Exclusion Criteria:
- •Stroke with multiple brain lesions
- •Addiction (e.g., alcohol or drugs)
- •Pregnancy
- •Major cognitive impairment (e.g., depression, aphasia, dementia)
- •Inability to perform or understand the required tasks
- •Uncontrolled health conditions
- •having already used the robotic devices
研究组 & 干预措施
Ipsilesional Group
Participants will have trainings on the REAplan® robot using their ipsilesional arm with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device using their ipsilesional hand with a serious game based on distal MSkL.
Participants will have assessment with each of their arms on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL
干预措施: REAplan® (Device)
Ipsilesional Group
Participants will have trainings on the REAplan® robot using their ipsilesional arm with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device using their ipsilesional hand with a serious game based on distal MSkL.
Participants will have assessment with each of their arms on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL
干预措施: Dextrain Manipulandum® (Device)
Control Group
Participants will only have assessment with each of their arms but not trainings on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL
干预措施: REAplan® (Device)
Control Group
Participants will only have assessment with each of their arms but not trainings on the REAplan® robot with a serious game based on proximal motor skill learning and on the Dextrain Manipulandum device with each of their hands with a serious game based on distal MSkL
干预措施: Dextrain Manipulandum® (Device)
结局指标
主要结局
Speed/Accuracy Trade-off (SAT) measured by the Dextrain Manipulandum
时间窗: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot
时间窗: change between baseline (Day 1) and after training (Day 3)
Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy
force measured by the REAplan® robot
时间窗: change between baseline (Day 1) and after training (Day 3)
forces exerted in the wrong direction by each arm (Newtons)
Root Mean Square Error (RMSE) measured by the Dextrain Manipulandum
时间窗: change between baseline (Day 1) and after training (Day 3)
error between the coordinates of the target and the cursor
次要结局
- Hold time measured by the Dextrain Manipulandum(change between baseline (Day 1) and after training (Day 3))
- Coactivation measured by the Dextrain Manipulandum(change between baseline (Day 1) and after training (Day 3))
- Voxel-based Lesion Symptom Mapping (VLSM)(Baseline)
- Diffusion Tensor Imaging (DTI)(Baseline)
- Fugl Meyer Upper Extremity Test (FMA-UE)(Day1)
- Oxford Cognitive Screen (OCS)(Day2)
- Action Research Arm Test (ARAT)(Day2)
- Fatigue Visual Analog Scale (VAS)(Day 1)
- Intrinsic Motivation Inventory (IMI)(Day3)
- Box and Block Test(change between baseline (Day 1) and after training (Day 3))
- Speed, Accuracy and Speed/Accuracy Trade-off (SAT) measured by the REAplan® robot on a Reaching task and on a Drawing task(change between baseline (Day 1) and after training (Day 3))
研究者
Pr Yves Vandermeeren, MD, PhD
MD, PhD, Neurologist, Principal Investigator, Clinical Professor
University Hospital of Mont-Godinne