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临床试验/NCT05268861
NCT05268861招募中不适用

The Role of Cognition in the Use of Enhanced Intrinsic Feedback for Motor Learning After Stroke

McGill University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Change in movement time

研究概览

简要总结

Stroke leads to lasting problems in using the upper limb (UL) for everyday life activities. While rehabilitation programs depend on motor learning, UL recovery is less than ideal. Implicit learning is thought to lead to better outcomes than explicit learning. Cognitive factors (e.g., memory, attention, perception), essential to implicit motor learning, are often impaired in people with stroke. The objective of this study is to investigate the role of cognitive deficits on implicit motor learning in people with stroke. The investigators hypothesize that 1) subjects with stroke will achieve better motor learning when training with additional intrinsic feedback compared to those who train without additional intrinsic feedback, and 2) individuals with stroke who have cognitive deficits will have impairments in their ability to use feedback to learn a motor skill compared to individuals with stroke who do not have cognitive deficits.

A recent feedback modality, called error augmentation (EA), can be used to enhance motor learning by providing subjects with magnified motor errors that the nervous system can use to adapt performance. The investigators will use a custom-made training program that includes EA feedback in a virtual reality (VR) environment in which the range of the UL movement is related to the patient's specific deficit in the production of active elbow extension. An avatar depiction of the arm will include a 15 deg elbow flexion error to encourage subjects to increase elbow extension beyond the current limitations. Thus, the subject will receive feedback that the elbow has extended less than it actually has and will compensate by extending the elbow further. Subjects will train for 30 minutes with the EA program 3 times a week for 9 weeks. Kinematic and clinical measures will be recorded before, after 3 weeks, after 6 weeks, and after 9 weeks. Four weeks after the end of training, there will be a follow-up evaluation. Imaging scans will be done to determine lesion size and extent, and descending tract integrity with diffusion tensor imaging (DTI).

This study will identify if subjects with cognitive deficits benefit from individualized training programs using enhanced intrinsic feedback. The development of treatments based on mechanisms of motor learning can move rehabilitation therapy in a promising direction by allowing therapists to design more effective interventions for people with problems using their upper limb following a stroke.

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)

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

  • Sustained a first cortical/sub-cortical ischemic/hemorrhagic stroke less than 3 years previously and are medically stable.
  • Are no longer receiving treatment.
  • Normal or corrected-to-normal vision.
  • Have arm paresis (Chedoke-McMaster Arm Scale 2-6/7) and spasticity (Modified Ashworth Scale ≥ 1/4) but can voluntarily flex/extend the elbow to approximately 30 degrees in each direction.

排除标准

  • Other major neurological or musculoskeletal problems that may interfere with task performance.
  • Marked elbow proprioceptive deficits (<6/12 Fugl-Meyer UL sensation scale) that may interfere with elbow position perception.
  • Visuospatial neglect (Line Bisection Test deviation > 6 mm).
  • Uncorrected vision.
  • Depression (≥ 14 Beck Depression Inventory II).

结局指标

主要结局

Change in movement time

时间窗: Change in movement time is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in movement time is assessed again 4 weeks after the completion of training

The time between the onset and offset of the movement.

Change in endpoint error

时间窗: Change in endpoint error is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in endpoint error is assessed again 4 weeks after the completion of training.

The distance between the endpoint marker and the target at the end of a reaching movement.

Change in range of active elbow extension

时间窗: The change in the range of active elbow extension is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in the range of active elbow extension is assessed again 4 weeks after the completion of training.

Determined by the tonic stretch reflex threshold (TSRT) -- the angle at which muscles begin to get recruited for movement at zero velocity.

Change in size of active arm workspace area

时间窗: The change in the size of the active arm workspace area is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in the size of the active arm workspace is assessed again 4 weeks after training.

The size of the active arm workspace area will be expressed as a ratio of the active workspace determined when the subject actively moves their arm through the horizontal workspace to the passive workspace that is defined by the examiner moving the arm through the same space.

Change in path straightness

时间窗: Change in path straightness is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in path straightness is assessed again 4 weeks after the completion of training.

Described using the index of curvature where the ratio between the actual movement path is compared to a straight line.

Change in path smoothness

时间窗: Change in path straightness is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in path smoothness is assessed again 4 weeks after the completion of training.

The number of peaks on a tangential velocity trace for each reaching trial.

次要结局

  • Correlation of the index of performance with the degree of cognitive and motor impairment, severity of damage to cortical areas, and white matter integrity.(Brain scans will be done prior to the start of training. Cognitive assessments and evaluations of motor impairment and activity are done prior to the start of training, after 3, after 6, after 9, and 4 weeks after the completion of training.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mindy F. Levin

Professor

McGill University

研究点 (2)

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