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临床试验/NCT03689491
NCT03689491已完成不适用

Investigating the Effects of Combining rTMS With Visual Feedback Training to Improve Movements in the Paretic Lower Limb and Gait Performance

Taipei Medical University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change of Motor evoked potential

研究概览

简要总结

After stroke, patients often experience motor deficits that interrupt normal lower extremity movement and gait function. Recent developments in neuroimaging have focus on the reasons why some patients recover well while some do poorly. However, there is still no consensus on the exact mechanisms involved in regaining the functions after rehabilitation. Application of repetitive transcranial magnetic stimulation (rTMS) to facilitate neural plasticity during stroke treatment has recently gained considerable attention. The possible mechanism through which rTMS acts is based on the interhemispheric competition (IHC) model, which explains that patients with stroke experience alterations in cortical excitability and exhibit abnormally high interhemispheric inhibition from the unaffected hemisphere to the affected hemisphere. The visual feedback training can improve postural control and enhance motor performance. Several rTMS studies have evaluated the lower extremity dysfunction following stroke, but few studies have explored the efficacy of applying rTMS on the lower extremities. We expect the study can help us to further exploration of the change of clinical function and cortical excitability following rTMS and visual feedback training in subjects with stroke. In addition, the results of this project will be provided for further rehabilitation programs in people with stroke.

详细描述

Objective

To investigate the effects of combining rTMS with visual feedback training to improve movements in the paretic lower limb and gait performance.

Methods: Thirty patients with monohemispheric after ischemic stroke will recruited and randomized into 3 groups. The group 1 received a 10-minute rTMS intervention then a 30-minute visual feedback training. The group 2 received a 10-minute sham rTMS intervention then a 30-minute visual feedback training. The group 3 received a 10-minute sham rTMS intervention then a 30-minute traditional rehabilitation training. All subjects received treatments 3 times a week for 4 weeks. The performance was assessed by a blinded assessor for two times (baseline and after 4 weeks). The outcome measures included Motor evoked potential (MEP), Fugl-Meyer Assessment-Lower Limb section(FMA-LE),Motor Assessment Score(MAS), Berg Balance Test (BBS),Time Up and Go (TUG), and Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis is combining rTMS with visual feedback training has positive effects on lower limb and gait performance among patients with 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
Single (Outcomes Assessor)

盲法说明

Single Blind (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Monohemispheric ischemic or hemorrhage stroke
  • Subjects with first-ever stroke 3.6 months after stroke onset
  • 4.The Brunnstrom stage of lower limb >Ⅲ 5.>23 in the mini-mental state exam 6.The Modified Ashworth Scale of lower limb <3 7.Clear consciousness can meet the relevant assessments

排除标准

  • Recurrent stoke
  • Severe spasticity of lower limb and difficult to perform isolative movement.
  • History of seizures or epileptic
  • Have implanted ferromagnetic devices or other magnetic-sensitive metal implants
  • Concomitant vestibular and cerebellum diseases
  • Joint contracture of lower limb/foot and other orthopedic problems
  • Subjects with severe cognitive impairment
  • Subjects with depression and/or mood disorder
  • Presence of any comorbid neurological diseases or psychological diseases

结局指标

主要结局

Change of Motor evoked potential

时间窗: Change from baseline to 4 weeks

Measurement of motor evoked potential of anterior tibialis

次要结局

  • Chang of Time Up and Go(Change from baseline to 4 weeks)
  • Chang of Fugl-Meyer Assessment-Lower Limb section(Change from baseline to 4 weeks)
  • Chang of Modified barthel index(Change from baseline to 4 weeks)
  • Chang of Motor Assessment Score(Change from baseline to 4 weeks)
  • Chang of Berg Balance Test(Change from baseline to 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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