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临床试验/NCT03124186
NCT03124186已完成不适用

Sensory-driven Motor Recovery in Poorly Recovered Subacute Stroke Patients

Lumy Sawaki0 个研究点目标入组 73 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
主要终点
Change in Fugl Meyer Assessment

研究概览

简要总结

This research project addresses a scientifically important question that cannot be answered by other means. The use of peripheral nerve stimulation has the potential to enhance recovery in subacute stroke patients with poor functional recovery. The primary objective of this proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor training has the ability to further improve hand motor function when compared to intensive training alone or nerve stimulation alone. The results from this study have the potential to develop new strategies in neurorehabilitation.

详细描述

Stroke is the leading cause of long-term disability in the United States. Approximately 70-88% of persons with ischemic stroke have some degree of motor impairment. A major goal of research in stroke rehabilitation is to harness the ability of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation (PNS) can be successfully combined to physical training, especially in poorly recovered subacute stroke patients. The proposed study will evaluate the effectiveness of sustained PNS coupled with motor training, to improve hand motor function in subacute stroke patients with severe motor deficit. Our preliminary data in chronic stroke patients with severe motor deficit demonstrate that motor function can be substantially enhanced when PNS is paired with motor training. In addition, a separate study in patients with mild motor deficit receiving motor training alone suggests that the optimal therapeutic time window to deliver motor training is within the first year after stroke. The improvement of behavioral motor function was associated with corticomotor reorganization. Therefore, this study proposes to evaluate the effectiveness of sustained PNS paired with motor training, to promote functional motor recovery in subacute stroke patients with severe motor deficit. The central hypothesis is that subacute stroke patients with severe motor deficit receiving PNS and intensive task-oriented therapy will have improved motor function compared to patients receiving sham-PNS and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation. The investigators plan to accept or reject the central hypothesis by accomplishing two Specific Aims: 1) test the effect of PNS preceding task-oriented therapy on hand motor function, and 2) test the effect of PNS preceding task-oriented therapy on motor map measured by transcranial magnetic stimulation. The long-range goals are: a) to maximize the restoration of hand motor function after stroke, b) to determine the impact of this intervention in activities of daily living, and c) collect solid data to prepare for a future multicenter randomized clinical trial.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Having sustained a single ischemic or hemorrhagic stroke during the 3- to 12-month period preceding enrollment
  • Single stroke
  • Inability at the time of screening to demonstrate active extension of the affected metacarpophalangeal and interphalangeal joints at least 10°; and the wrist, 20° (ie, level of impairment that would preclude participation in constraint-induced therapy)
  • Score of 47 or lower on the modified 30-item Fugl-Meyer Assessment of UE motor function
  • Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

排除标准

  • History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
  • History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
  • Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
  • Cognitive deficit severe enough to preclude informed consent
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Participants with history of untreated depression.

结局指标

主要结局

Change in Fugl Meyer Assessment

时间窗: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline

The upper extremity FMA is a quantitative measure of motor recovery, sensation, coordination, and speed.

次要结局

  • Change in Stroke Impact Scale (SIS)(Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline)
  • Change in Action Arm Research Test (ARAT)(Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline)
  • Change in Wolf Motor Function Test (WMFT)(Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline)

研究者

发起方
Lumy Sawaki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lumy Sawaki

Principal Investigator

University of Kentucky

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