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临床试验/NCT04059848
NCT04059848已完成不适用

Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 30 人开始时间: 2017年1月13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
30
主要终点
Action Research Arm Test

研究概览

简要总结

The purpose of this study was to investigate the effects of the combination treatment strategy. A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset > 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

详细描述

Background and objectives: Previous studies have shown that transcranial direct current stimulation (tDCS) and Neuromuscular electrical stimulation (NMES) could be effective for promoting motor recovery of stroke patients. However, the effects of tDCS combined with NMES on upper extremity (UE) motor recovery in patients with stroke have not been investigated. The purpose of this study was to investigate the effects of the combination treatment strategy. Methods: A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset > 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. Results: Most of the participants had mild to moderate disability in activity of daily living. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. Conclusion: This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

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
Double (Participant, 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

  • First onset
  • Ischemic stroke
  • Stroke onset > 6 months
  • Brunnstrom recovery stage: ≧3
  • Modified Ashworth Scale Elbow flexor : ≦3

排除标准

  • Severe language or cognitive impairment
  • Orthopaedic or neurological problems
  • Pregnancy
  • Contraindications for tDCS or NMES

研究组 & 干预措施

tDCS combined with NMES

Experimental

In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

干预措施: tDCS(Intelect Mobile Stimulation and Combination, DJO, France) (Combination Product)

tDCS combined with NMES

Experimental

In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

干预措施: NMES(Enraf Nonius, Endomed-182, Netherlands) (Combination Product)

tDCS combined with sham NMES

Active Comparator

In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

干预措施: tDCS(Intelect Mobile Stimulation and Combination, DJO, France) (Combination Product)

tDCS combined with sham NMES

Active Comparator

In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

干预措施: NMES(Enraf Nonius, Endomed-182, Netherlands) (Combination Product)

sham tDCS combined with sham NMES

Sham Comparator

In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

干预措施: tDCS(Intelect Mobile Stimulation and Combination, DJO, France) (Combination Product)

sham tDCS combined with sham NMES

Sham Comparator

In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

干预措施: NMES(Enraf Nonius, Endomed-182, Netherlands) (Combination Product)

结局指标

主要结局

Action Research Arm Test

时间窗: at beginning of the intervention, after 3-week of treatment, and one-month follow-up

The ARAT(Lyle, 1981) has 19 items in four categories: grasp, grip, pinch, and gross movement. Each item is graded on a 4-point scale, from 0 to 3. The total score has a range of 0 to 57.

upper extremity subscale of Fugl-Meyer assessment

时间窗: at beginning of the intervention, after 3-week of treatment, and one-month follow-up

The Fugl-Meyer assessment consists of the 33-item upper-extremity (UE-FM) and 17-item lower-extremity subscales.(Fugl-Meyer et al., 1975) The items of the FM are mainly scored on a 3-point scale, from 0 to 2. The total score of the UE-FM ranges from 0 to 66.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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