跳至主要内容
临床试验/NCT04378946
NCT04378946Unknown不适用

Making Training Better: Error Augmentation Motor Learning in Stroke

McGill University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
54
试验地点
2
主要终点
Change in elbow spatial threshold (ST) angle and the range of active elbow extension

研究概览

简要总结

Deficits in upper limb (UL) functional recovery persist in a large proportion of stroke survivors. Understanding how to obtain the best possible UL recovery is a major scientific, clinical and patient priority. We propose that UL motor recovery may be improved by training that focuses on remediating an individual's specific motor impairment. Our approach is based on evidence that deficits in the control of muscle activation thresholds (spatial thresholds) of the elbow in stroke underlie impairments such as disordered movement and spasticity. Our novel training program focuses on improving the individual's active elbow control range using error augmentation (EA) feedback. Since training intensity and lesion load are key factors in motor recovery that lack guidelines, we will also investigate effects of exercise dose and corticospinal tract (CST) injury on UL recovery.

In this multicenter, double-blind, parallel-group, randomized controlled trial (RCT), patients with stroke will participate in an individualized intensive technology-assisted reaching training program, based on error augmentation (EA), in order to improve voluntary elbow function. They will practice robot-assisted reaching in a virtual reality (VR) game setting. We will identify if intensive training with feedback aimed at expanding the range of spatial threshold (ST) control at the elbow (experimental group) is better than intensive training with general feedback about task success (control group). We will also determine the patient-specific optimal therapy dose by comparing kinematic and clinical outcomes after 3, 6 and 9 weeks of intensive training, and again at 4 weeks after training to determine carry-over effects. We will quantify the severity of the participant's motor deficit, as the amount of cortico spinal tract (CST) injury due to the stroke (%CST injury) and relate training gains to their %CST injury. Results of this pragmatic trial will provide essential information for optimizing individualized post-stroke training programs and help determine optimal patient-specific training dosing to improve motor recovery in people with different levels of stroke severity.

This type of research involving personalized, impairment-based feedback and dose-effective training has the potential to significantly improve rehabilitation for a greater number of post-stroke individuals and improve the health and quality of life of Canadians.

详细描述

Recovery of upper limb movement after stroke is incomplete. Stroke is a leading cause of long-term sensorimotor disability including persistent deficits in upper limb (UL) function. Understanding how to improve UL recovery is a major scientific, clinical and patient priority. Yet, despite numerous studies attempting to identify the most effective rehabilitation interventions based on established principles of motor learning and neural plasticity, post-stroke UL recovery remains incomplete. Indeed, even with therapy, UL sensorimotor deficits persist in a large proportion (up to 62%) of stroke survivors for >6 months leading to a high socio-economic burden.

MOTOR CONTROL DISORDERS: A consequence of the underlying control deficit after stroke is hemiparesis, characterized by a diminished capacity to recruit agonist muscles, unwanted/inappropriate muscle activation (i.e., spasticity, agonist and antagonist muscle co-contraction), abnormal muscle activation timing, weakness and muscle fiber property changes. This leads to deficits in the ability to isolate joint movement and appropriately combine different joints to accomplish task-related functions. We have accumulated substantial evidence suggesting that movement deficits and spasticity are associated with a common control deficit in the specification and regulation of spatia thresholds (ST) of the stretch reflex and other proprioceptive reflexes. STs are expressed in the spatial (angular) rather than the temporal (latency) domain. ST regulation is a well-established mechanism of control of stretch reflexes in animals and reflexes and movements in humans.

ST DEFINITION AND ACTION MECHANISMS: Spatial threshold (ST) is the joint angle at which muscles begin to be recruited and postural reflexes and other reflexes begin to act. By shifting ST, the brain resets posture-stabilizing mechanisms to a new limb or body position. These mechanisms combine to regulate STs in multi-muscle systems according to body configuration and task demands. Stroke results in deficits in ST regulation. Central nervous system (CNS) injuries affecting descending and spinal mechanisms and intrinsic lead to limitations in ST regulation. As a result, passive or active movements past the angular threshold, ST (spasticity range), elicit abnormal reflex muscle activation. The ST is velocity-dependent reducing the active control range in stroke patients and their ability to make faster movements.

INTERVENTION APPROACH: Our approach is designed to increase the reflex-free range of elbow motion in stroke. Adaptation of elbow movement to a new load (i.e., the ability to correct errors) in patients with chronic stroke was substantially improved when movement was made within the active control range (where spasticity did not affect muscle contraction) compared to when the reflex-free range was not identified. Accordingly, the potential for motor learning may be improved by considering the range of impaired elbow movement in properly designed trials. To avoid eliciting movements made with abnormal muscle activation patterns and other compensations (bad plasticity), training programs will be tailored to the movement capacity of the individual and incorporate approaches that quantify and enlarge the joint range made with typical muscle activation patterns. In this proposal, we will use a robot and a novel VR learning interface to manipulate the ability to produce controlled movement at the elbow, which is a common impairment in people with moderate to severe stroke. The proposed personalized training approach focuses on providing specific feedback to increase an individual's ST regulation range.

ERROR AUGMENTATION FEEDBACK (EA): Error Augmentation feedback will be used to increase the active control ST zone of the elbow. EA uses intrinsic error-driven learning to enhance the CNS's ability to take advantage of kinematic redundancy and find meaningful motor task solutions. Specifically, subjects are provided with feedback that enhances their motor errors. Manipulation of error signals has been shown to stimulate UL sensorimotor improvement in both healthy and stroke subjects with greater learning gains occurring when errors are larger. EA feedback will be used to dynamically remap the active elbow control range. Visual feedback about elbow angle will be modified, to make it seem as if the elbow moves less than in reality. Thus, when the actual elbow moves, the subject perceives the elbow as having moved less and attempts to correct the error by extending the elbow further. The active control range will be expanded by having subjects working near or just at the limit of their ST range. Remapping of the perception/action relationship will occur when the afferent feedback becomes associated with a greater elbow angle. Given the key role of errors in motor learning, artificially increasing the performance error via EA will increase each individual's active control range and cause learning to occur more quickly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Allocation will be concealed from the individual assigning participants to groups until the moment of assignment. The therapist will be notified of subject group allocation via a sealed envelope prior to the first treatment session. Participants will also be blinded to group allocation. Finally, those assessing outcomes as well as those analysing data will be blinded by concealing patient group allocation.

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First cortical/sub-cortical ischemic/hemorrhagic stroke less than 1 year previously
  • Sub-acute stage
  • Medically stable
  • Not in treatment
  • Arm paresis (Chedoke-McMaster Arm Scale of 2-6 out of 7
  • Some voluntary elbow movement (30° per direction)
  • Able to provide informed consent

排除标准

  • Major neurological neuromuscular/orthopaedic/pain problems
  • Marked proprioceptive deficits at the elbow (<6/12 Fugl-Meyer UL Proprioception Scale)
  • Visuospatial neglect
  • Uncorrected visual deficits
  • Major cognitive deficits (< 26 on MOCA)
  • Depression (> 14 on BDI II)

结局指标

主要结局

Change in elbow spatial threshold (ST) angle and the range of active elbow extension

时间窗: Before treatment baseline, week 3, week 6, week 9 and week 13

The elbow ST angle will be identified with the Montreal Spasticity Measure (MSM). The range of active elbow extension during a standardized reach-to-grasp Test Task made to a hollow cone placed in the subject's midline will be evaluated. This task has been used in previous clinical trials to test reaching in a similar stroke cohort and norms for healthy participants are available. Although only the reach-to-grasp movement will be analyzed, the whole task will be done so that the action is more functional (e.g., having a specific purpose).

次要结局

  • Arm workspace area, movement quality variables, clinical measures of UL functional level(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in arm workspace area during reach task(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in spasticity level at rest(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in straightness of elbow trajectory during reach task(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in speed of endpoint movement during reach task(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in smoothness of endpoint trajectory during reach task(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in accuracy relative to target during reach task(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in Fugl-Meyer Assessment Upper extremity (FMA)(Before treatment baseline, week 3, week 6, week 9 and week 13)
  • Change in streamlined Wolf Motor Function Test (WMFT)(Before treatment baseline, week 3, week 6, week 9 and week 13)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验