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临床试验/NCT04687033
NCT04687033已完成不适用

The Effect of The Ten-Session Dual-tDCS On Lower-Limb Performance in Sub- Acute and Chronic Stroke

Mahidol University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月1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
34
试验地点
1
主要终点
Change from baseline gait speed at post-intervention

研究概览

简要总结

The present study aims to determine the effect of the ten-session dual tDCS combine with physical therapy on gait performance, balance, and lower limbs muscle strength in patients with subacute and chronic stroke.

详细描述

Stroke is a leading cause of long-term disability. The recovery of motor function after stroke is often incomplete, despite classical rehabilitation techniques. At the beginning of the 21st century, transcranial direct current stimulation (tDCS) was introduced as a non-invasive tool to reversibly modulate brain excitability in humans in which a device sends constant low direct current (DC) delivered to the area of interest through the electrodes. Transcranial direct current stimulation (tDCS) has been used in neurorehabilitation to benefit ischemic stroke patients at a different stage of stroke especially during acute, sub-acute and chronic phase with positive and safety reports.

After stroke, the excitability of the lesioned hemisphere is decreased and seen like overactive of the excitability of the non-lesioned hemisphere. Abnormally high interhemispheric inhibition (IHI) drive from intact to lesioned hemisphere has been reported. The neural plasticity begins in the early stages after stroke. Prevent the imbalance IHI and increase the excitability of the lesioned hemisphere in the early phase would be beneficial for stroke rehabilitation.

Based on the polarity-specific effects, anodal tDCS increases cortical excitability and cathodal tDCS decreases cortical excitability. Transcranial direct current stimulation (tDCS) can be applied in two distinct montages: monocephalic and bi-hemispheric/dual-tDCS (applying two electrodes over both cerebral hemispheres at the same time). To induce post-stroke motor recovery, two different monocephalic montages are typically used: i) to restore excitability in the lesioned hemisphere: anode over the lesioned hemisphere and the cathode as the reference electrode placed over the contra-orbital area ii) to down-regulate the excitability of the non-lesioned hemisphere and rebalance IHI: cathode over the non-lesioned hemisphere and the anode as the reference electrode. Dual-tDCS can be also applied, permitting simultaneous coupling of excitatory and inhibitory effects on both cortices. Few evidences are showing that tDCS (monocephalic and bi-hemispheric/dual-tDCS) could improve lower limb performance at immediate and at least 3 months. However, there is still unclear effect on gait performance and muscle strength.

Recently, dual-hemisphere tDCS which excites one hemisphere using anodal stimulation and inhibits the other by cathodal stimulation has been described in healthy volunteers to greater enhance hand motor learning compared to uni-hemispheric tDCS. The corresponding tDCS-induced changes were reported in imaging study to involve interhemispheric interactions. Dual tDCS has been more recently used in rehabilitation aiming to reduce the inhibition exerted by the non-lesioned hemisphere on the lesioned hemisphere and restore the normal balance of the IHI. Dual-tDCS combined with training or simultaneous occupational/physical therapy has been reported to improve motor skill learning and functions of the paretic upper limb in chronic stroke patients.

Lower-limb functions are commonly disabling after stroke, however, few studies have focused on the effect of tDCS on lower limb functions. A single session of anodal tDCS over the lower limb M1 has been reported to acutely enhance the effect of motor practice of the paretic ankle, force production of the paretic knee extensors, and postural stability in chronic stroke patients. A study showed an improvement in walking speed immediately after a single session of dual-tDCS alone in sub-acute stroke patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range 20-75 years
  • •First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. Diagnostic confirmation will be performed by CT scan or MRI
  • •Sub-acute onset (1-6 months after the stroke onset) or Chronic (6 months - 5 years)
  • •Able to walk without physical assistance at least 6 meters

排除标准

  • •Not cooperative or cannot understand the instruction
  • •Clinical unstable such as vital sign unstable (systolic blood pressure (SBP) ≥ 185 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (98) and resting heart rate averaging ≥ 100 bpm (99))
  • •No clear neurological antecedent history or psychiatric disorder
  • •Moderate pain in any joint of both lower limb (Pain Scale (VAS) ≥ 4/10)
  • •Unstable medical conditions such as being in the middle of changing medical treatment.
  • •Condition that may increase the risk of stimulation such as epilepsy, pregnancy, unexplained headaches, intracranial metal, pacemaker (evaluating by subjective examination).
  • •Participate in the other protocol or receive alternative treatment such as transcranial magnetic stimulation within 1 month.

研究组 & 干预措施

Dual-tDCS & PT

Experimental

Dual tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere for 20 mins before physical therapy (about

1 hour). The current intensity is fixed at 2 mA and the current will flow continuously. Physical therapist will give an intervention program for lower limb performance.

干预措施: Transcranial direct current stimulation (Device)

Sham-tDCS & PT

Active Comparator

Sham tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere, the current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performance.

干预措施: Transcranial direct current stimulation (Device)

结局指标

主要结局

Change from baseline gait speed at post-intervention

时间窗: immediately post-intervention

Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

Change from baseline gait speed at 1 week post-intervention

时间窗: 1 week post-intervention

Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

Change from baseline gait speed at 1 month post-intervention

时间窗: 1 month post-intervention

Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

Change from baseline gait speed at 2 month post-intervention

时间窗: 2 month post-intervention

Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

Change from baseline gait speed at 3 month post-intervention

时间窗: 3 month post-intervention

Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

次要结局

  • Change from baseline spatiotemporal gait variable at post-intervention(immediately post-intervention)
  • Change from baseline spatiotemporal gait variable at 1 week(1 week post-intervention)
  • Change from baseline spatiotemporal gait variable at 1 month(1 month post-intervention)
  • Change from baseline spatiotemporal gait variable at 2 months(2 months post-intervention)
  • Change from baseline spatiotemporal gait variable at 3 months(3 months post-intervention)
  • Change from baseline muscle strength at post-intervention(immediately post-intervention)
  • Change from baseline Stroke Impact Scale at 1 week(1 week post-intervention)
  • Change from baseline muscle strength at 1 week(1 week post-intervention)
  • Change from baseline muscle strength at 1 month(1 month post-intervention)
  • Change from baseline muscle strength at 2 months(2 months post-intervention)
  • Change from baseline muscle strength at 3 months(3 months post-intervention)
  • Change from baseline FMA-LE at post-intervention(immediately post-intervention)
  • Change from baseline FMA-LE at 1 week(1 week post-intervention)
  • Change from baseline FMA-LE at 1 month(1 month post-intervention)
  • Change from baseline FMA-LE at 2 months(2 months post-intervention)
  • Change from baseline FMA-LE at 3 months(3 months post-intervention)
  • Change from baseline Stroke Impact Scale at post-intervention(immediately post-intervention)
  • Change from baseline Stroke Impact Scale at 1 month(1 month post-intervention)
  • Change from baseline Stroke Impact Scale at 2 months(2 months post-intervention)
  • Change from baseline Stroke Impact Scale at 3 months(3 months post-intervention)
  • Change from baseline Timed-up and go test (TUG) at post-intervention(immediately post-intervention)
  • Change from baseline Timed-up and go test (TUG) at 1 week(1 week post-intervention)
  • Change from baseline Timed-up and go test (TUG) at 1 month(1 month post-intervention)
  • Change from baseline Timed-up and go test (TUG) at 2 months(2 months post-intervention)
  • Change from baseline Timed-up and go test (TUG) at 3 months(3 months post-intervention)
  • Change from baseline Five Times Sit to Stand Test (FTSTS) at post-intervention(immediately post-intervention)
  • Change from baseline Five Times Sit to Stand Test (FTSTS) at 1 week(1 week post-intervention)
  • Change from baseline Five Times Sit to Stand Test (FTSTS) at 1 month(1 month post-intervention)
  • Change from baseline Five Times Sit to Stand Test (FTSTS) at 2 months(2 months post-intervention)
  • Change from baseline Five Times Sit to Stand Test (FTSTS) at 3 months(3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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