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临床试验/NCT05013762
NCT05013762已完成不适用

Fast Training Promotes Recovery of Arm Movements Post-stroke Via Cerebellar-mediated Anticipatory Feedforward Control

University of Southern California2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Change in arm reaching movement time.

研究概览

简要总结

Every year, almost 800,000 people experience a stroke in the United States, which lead to upper-limb impairments, making recovery of motor function a priority in stroke rehabilitation. 1) The primary objective of this study is to determine whether fast arm movement training on a tracking task ("Speed-training"), in chronic stroke survivors with mild to moderate paresis, will generalize to improve arm function better than dose-equivalent accuracy training on the same task. 2) study the effect of intensive arm training on the recovery of anticipatory feedforward control. 3) Determine the involvement of cerebellar-cortical circuits in the recovery of arm movements due to speed training.

详细描述

About 65% of stroke survivors experience long-term limitations in upper extremity (UE) functions. In particular, limitations in arm reaching movements are prominent and correlate strongly with patients' impairment levels. Because activities of daily living often involve the UEs, retraining reach and grasp skills is critical for return to a full quality-of-life. Yet, the training parameters required for effective rehabilitation of UE function are not known. Recent evidence suggests that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke. Hence, fast movements generating large errors, would promote the restoration of the feedforward controllers and therefore improves arm movements and UE functions in individuals with chronic stroke. Because the cerebellum is involved in learning feedforward controllers from motor errors, the improvements would be proportional to the integrity of the cerebellar-cortical networks.

A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke survivors. Participants will be assigned to either the speed-bias training group or a dose equivalent accuracy-bias training group (control) and will receive 4 days of training over a 1week period by a trained Occupational or physical therapist. Behavioral, EMG, and MRI data will be acquired within two weeks before, 3 days post, and one month after intervention.

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
Single (Outcomes Assessor)

盲法说明

Assessments will be done by a blinded and standardized clinical researcher

入排标准

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

入选标准

  • At least 6 months following an ischemic supratentorial stroke
  • At least 21 years of age
  • Exhibit residual capability to move the paretic UE (Upper Extremity Fugl- Meyer motor score >20/66)
  • Able to follow a 2-step command (8th item on the MMSE test)
  • Able to perform an unassisted arm reach movement of 25 cm ahead of the body within 5 seconds with trunk restraint
  • Exhibit no greater than mild/moderate spasticity as assessed with a Modified Ashworth Score < 3

排除标准

  • any neurologic diagnoses other than stroke
  • peripheral movement restrictions, such as neuropathy
  • orthopedic disorders affecting the paretic UE
  • severe pain or sensory/proprioceptive impairment in the more affected UE
  • visual neglect (more than 4% of lines left uncrossed on Albert's test).
  • had a stroke directly affecting the cerebellum
  • any contra-indications to MRI scanning
  • mostly resolved impairments with an Upper Extremity Fugl- Meyer motor score >58/66

研究组 & 干预措施

Speed-biased complex motor skill training

Active Comparator

Participants will perform 400 complex movements per day over 4 days over a one-week period. The task requires participants to navigate their hand through a "track" projected on the surface of a table with a width of 5cm. Participants receive adaptive score based on their movement time. .

干预措施: Fast intervention (Behavioral)

Accuracy-biased complex motor skill training

Other

The accuracy-biased group receives a dose equivalent intervention with a emphasize on accuracy. The width of the track projected on the table is narrower (less than 2cm) and the adaptive score received are based on their accuracy to say within the boundary of the track.

干预措施: Active Monitoring (Behavioral)

结局指标

主要结局

Change in arm reaching movement time.

时间窗: Change from baseline to 1 month post-intervention

Average movement time for 30 planar reaching movements to target arrayed on a planar workspace.

Change in speed Accuracy Trade-off

时间窗: Change from baseline to 1 month post-intervention

The investigators will compute the "Fitts" slope between "index of difficulty" of reaching movements and movement time, for targets at 3 distances and of 4 diameters.

Change in movement smoothness

时间窗: Change from baseline to 1 month post-intervention

Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace. Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements.

Change in Arm Reaching Movement Time.

时间窗: Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days

Average movement time for 30 planar reaching movements to targets arrayed on a planar workspace. Negative changes indicate that participants moved faster to the targets following the intervention.

Change in Movement Smoothness

时间窗: Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days

Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace. Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements. Negative changes indicate that participants had smoother movement to the targets following the intervention.

Change in Speed Accuracy Trade-off

时间窗: Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days

The speed-accuracy trade-off of reaching movements was assessed as a linear relationship between movement time and the Index of Difficulty : log ratio of the movement distance to target size. Negative changes indicate that participants are less affected by the index of difficulty, reflecting a better speed-accuracy trade-off.

Change in Arm Reaching Movement Time.

时间窗: We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.

Average movement time for 30 planar reaching movements to targets arrayed on a planar workspace. Negative changes indicate that participants moved faster to the targets following the intervention.

Change in Movement Smoothness

时间窗: We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.

Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace. Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements. Negative changes indicate that participants had smoother movement to the targets following the intervention.

Change in Speed Accuracy Trade-off

时间窗: We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.

The speed-accuracy trade-off of reaching movements was assessed as a linear relationship between movement time and the Index of Difficulty : log ratio of the movement distance to target size. Negative changes indicate that participants are less affected by the index of difficulty, reflecting a better speed-accuracy trade-off.

次要结局

  • Change in Box and Block test score (BBT)(Change from baseline to 1 month post-intervention)
  • Change in Upper Extremity Fugl-Meyer (UEFM)(Change from baseline to 1 month post-intervention)
  • Change in Action Research Arm Test (ARAT)(Change from baseline to 1 month post-intervention)
  • Change in Action Research Arm Test (ARAT)(Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days)
  • Change in Upper Extremity Fugl-Meyer (UEFM)(Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days)
  • Change in Box and Block Test Score (BBT)(Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days)
  • Change in Action Research Arm Test (ARAT)(We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.)
  • Change in Upper Extremity Fugl-Meyer (UEFM)(We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.)
  • Change in Box and Block Test Score (BBT)(We evaluated the change from baseline (assessed during the week preceding the intervention) to one month post-intervention, representing an average interval of 40 days.)

研究者

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

Carolee Winstein

Professor, Biokinesiology and Physical Therapy

University of Southern California

研究点 (2)

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