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New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.

2017年9月7日 更新者:Chang Gung Memorial Hospital

New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.

The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor function within each patient's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting patient's participation in their lives. In addition to employ clinical measures after treatment, usual outcome measures employed in the intervention studies included movement kinematics (spatio-temporal characteristics of movements). Recent reports have suggested repetitive transcranial magnetic stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and continuous TBS (cTBS), that modulates human cortical excitability differently. However, there is lack of literatures in verifying the treatment effect by the integration of clinical and kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies investigate the possible clinical characteristics of patients with stroke that may influence the effects of various treatment protocols proposed in this project.

研究概览

详细说明

The research program aims at studying patients with stroke the immediate and maintaining effects of new upper-extremity (UE) treatment protocols after brain damage and identifying the possible mechanisms underlying treatment-induced changes in patients with stroke. This research will study new treatment approaches that have been formulated based on principles of integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).

  1. To compare the movement functions and motor control in patients with stroke of different motor severities.
  2. To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.
  3. To evaluate motor control and clinical outcomes after different treatment approaches applied in the UE training of patients with stroke. The treatment approaches to be studied will include different protocols. We hypothesize that there will be improvements in movement performance after the treatment and the level of post-treatment performance will differ among the treatments through different reorganization patterns.

    3.1 To compare the motor control and clinical outcomes after different treatment approaches.

    3.2 To identify the optimal treatment protocol for patients with stroke.

  4. To investigate the possible predictors of treatment outcome associated with motor severity, movement and participation for each type of treatments. The possible predictors will include brain lesions, and severity. We hypothesize that the proposed prognostic factors will predict treatment outcomes.
  5. To analyze the association between motor reorganization measured by kinematic study and behavioral improvement in motor severity, movement and participation measured by clinical tools.

Treating motor dysfunction in patients with stroke requires an understanding of the mechanism underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor function in patients with various disorders. However, there are few researches in identifying the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with stroke. There is lack of literatures in verifying the treatment effect by movement control studies. The current research will offer valuable kinematic data that support neural-motor models proposed to account for motor control problems in these patients. More important, we will identify the new protocol in the treatment of upper limb dysfunctions in patients with stroke through integration of clinical and kinematic measures. We will identify clinical predictors influencing the outcome for different treatment approaches, and analyze the association between motor control and clinical measures involving motor severity, movement and participation. We believe the results of this study will refine services and supports for patients with stroke to meet these goals. This study may potentially provide directions in kinematic measures for future studies on patients with stroke.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taoyuan、台湾、333
        • Chang Gung Memorial Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age: 20-80 y/o
  • patients with 1st onset cerebral stroke.

Exclusion Criteria:

  • Brain stem or cerebellar stroke
  • Contraindication to MRI, such as metallic implant
  • Contraindication to BoNTA, such as poor controlled epilepsy
  • History of psychiatric disease
  • Received BoNTA injection or surgery in recent six months
  • Severe psychological impairments, such as mental retardation, autism, or severe Communication problems
  • Progressive disorders, such as neurodegenerative disease
  • Active medical disease, such as infection

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:iTBS集团
在间歇性 theta 爆发刺激(iTBS 组)中,他们在受影响的半球接受 iTBS(主动运动阈值的 80%)。
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total)
实验性的:cTBS组
在连续 θ 爆发刺激(cTBS 组)中,他们在未受影响的半球接受 cTBS(主动运动阈值的 80%)。
In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total).
其他名称:
  • continuous burst stimulation
假比较器:假TBS组
在假θ爆发刺激(假TBS组)中,他们接受了假TBS刺激。
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 600 pulses in total).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
大体时间:baseline, after treatment, 3 months , 6 months
Kinematic analysis for upper limb analysis.
baseline, after treatment, 3 months , 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年12月1日

初级完成 (实际的)

2017年6月1日

研究完成 (实际的)

2017年6月1日

研究注册日期

首次提交

2013年9月18日

首先提交符合 QC 标准的

2013年9月18日

首次发布 (估计)

2013年9月20日

研究记录更新

最后更新发布 (实际的)

2017年9月11日

上次提交的符合 QC 标准的更新

2017年9月7日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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