跳至主要内容
临床试验/NCT05760846
NCT05760846招募中不适用

Exploring the Neural Substrates of Proximal and Distal Bimanual Motor Skill Learning Through Robotics and Multimodal Brain Imaging

University Hospital of Mont-Godinne3 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年4月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
3
主要终点
bimanual Coordination factor (bi-CO), bimanual Coordination factor measured by the REAplan® robot

研究概览

简要总结

The subacute phase of stroke provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. The recovery from motor impairment has been extensively studied, but it is currently unknown whether motor skill learning (MSkL) is enhanced or impaired during acute stroke, especially bimanual motor skill learning (bim-MSkL), which likely requires more motor-attentional-cognitive resources than unimanual MSkL.

The goals of this project are: to determine the neural substrates critical to achieve proximal and distal bimanual motor skill learning (bim-MSkL) by specifying whether (sub)acute stroke to different brain areas (cortical and subcortical) induce specific deficits in bimanual and/or distal bim-MSkL, which behavioral components are involved in bim-MSkL, and whether damage to the motor, sensory and inter-hemispheric pathways specifically impairs proximal and/or distal bim-MSkL.

详细描述

Over 3 consecutive days, the patients will be evaluated and will train on the rehabilitation robot REAplan® (http://www.axinesis.com/) to assess proximal bim-MSkL and on the manual dexterity tool Dextrain Manipulandum (https://www.dextrain.com/) to assess distal bim-MSkL.

For proximal bim-MSkL, patients will train over the 3 days on the serious game Circuit on the bimanual REAplan® and will be randomised to two different bimanual versions. By this means, the investigators will explore the components of bim-MSkL in acute stroke patients.

The motor skill learning setup (Circuit) that was developed and successfully used in healthy individuals and stroke patients has already been implemented in the REAplan® environment and will be used as innovative serious games based on a speed/accuracy trade-off (SAT), allowing a detailed analysis of motor skill learning components (speed, accuracy, SAT, movement smoothness, dynamics...). For the serious game Circuit, who based on motor skill learning, the subjects will have to practice a complex circuit and move a cursor as quickly and accurately as possible by controlling the handles of the robot with both arms.

For distal bim-MSkL, patients will train on a complex sequence of finger movements involving both hands. Each day, several successive repetitions of the sequence will be displayed, corresponding to one block. 3 to 6 blocks will be repeated, each separated by 30 sec of rest. After training on the third day, a new sequence will be repeated for 3 blocks to assess generalization.

To explore the role of different brain structures in bim-MskL, 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 proximal/distal bim-MskL 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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ACUTE STROKE PATIENTS:
  • Inclusion Criteria:
  • acute stroke (< 21 days)
  • aged 18-90 years
  • with a demonstrated stroke (ischemic or hemorrhagic) lesion on brain imaging

排除标准

  • " 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 strokes / dementia / psychiatric condition
  • HEALTHY INDIVIDUALS:
  • Inclusion Criteria:
  • 18-90 years
  • Exclusion Criteria:
  • medical history with a previous stroke / relevant neurological deficit
  • drug/alcohol abuse
  • psychiatric condition/ dementia

研究组 & 干预措施

Bimanual Circuit version 2

Experimental

Training on the REAplan® robot with a serious game based on motor skill learning (MSkL) with bimanual version 2 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL

干预措施: REAplan® (Device)

Bimanual Circuit version 2

Experimental

Training on the REAplan® robot with a serious game based on motor skill learning (MSkL) with bimanual version 2 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL

干预措施: Dextrain Manipulandum® (Device)

Bimanual Circuit version 1

Experimental

Training on the REAplan® robot with a serious game based on proximal motor skill learning (bim-MSkL) with the bimanual version 1 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL

干预措施: REAplan® (Device)

Bimanual Circuit version 1

Experimental

Training on the REAplan® robot with a serious game based on proximal motor skill learning (bim-MSkL) with the bimanual version 1 of the Circuit task and training on the Dextrain Manipulandum with a serious game based on distal bim-MSkL

干预措施: Dextrain Manipulandum® (Device)

结局指标

主要结局

bimanual Coordination factor (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

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)

Bimanual Dexterity Coordination Index measured by the Dextrain 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 thumb-index clamps

bimanual Speed/Accuracy Trade-off (bi-SAT), bimanual Speed/Accuracy Trade-off measured by the REAplan® robot

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

bimanual Speed/Accuracy Trade-off: mathematical computation of the relationship between speed and accuracy

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)

Tracking error between the actual applied force and the target force

次要结局

  • Hold time 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)
  • Coactivation measured by the Dextrain Manipulandum(change between baseline (Day 1) and after training (Day 3))
  • Fugl Meyer Upper Extremity Test (FMA-UE)(Day1)
  • Rise time measured by the Dextrain Manipulandum(change between baseline (Day 1) and after training (Day 3))
  • Reaction time measured by the Dextrain Manipulandum(change between baseline (Day 1) and after training (Day 3))
  • Montreal Cognitive Assessment (MoCA)(Day 1)
  • Shoulder Abduction Finger Extension (SAFE) test(Day 1)
  • Modified Ashworth Scale (mAS)(Day 1)
  • Arm Motor Ability (AMA) test(Day 1)
  • Fatigue Visual Analog Scale (VAS)(Day 1)

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

Principal Investigator

University Hospital of Mont-Godinne

研究点 (3)

Loading locations...

相似试验

Bimanual Motor Skill Learning in Acute Stroke | 临床试验