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临床试验/NCT06061731
NCT06061731已完成早期 1 期

Master's Degree Candidate in Acupuncture and Tuina

Xue Xia1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
sEMG eigenvalues

研究概览

简要总结

Abstract:

Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.

详细描述

Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • ①Diagnostic criteria for upper extremity motor dysfunction after stroke. ②Age 35-75 years and duration of illness is 2 weeks to 3 months. ③ Impaired hand function with Lovett classification ≥ grade 2 and MAS ≤ grade
  • ④No organ dysfunction such as heart, liver, lung, kidney or blood circulation dysfunction. ⑤Clear consciousness, no major impairment in intelligence, hearing or speech, and stable condition. ⑥Patients voluntarily participated in this subject trial and signed the informed consent form.

排除标准

  • Presence of neurological or musculoskeletal disorders affecting functional recovery prior to the onset of the disease. ②Brainstem infarction, bilateral cerebral infarction or transient ischemic attack.

研究组 & 干预措施

Low frequency group treatment

Active Comparator

Low frequency group treatment: The treatment frequency is selected as 50Hz, pulse width 0.3ms, waveform is intermittent waveform, stimulation intensity is tolerated by the patient, the instrument program is set to stimulate the first group of acupoints → second group → first group → third group, forming a set of programmed movements, cyclic operation, appearing alternate movements of flexor and extensor muscles, namely: wrist dorsal extension, five-finger extension → five-finger flexion → wrist dorsal extension, five-finger extension → thumb-index finger pair pinching, simulating fine movements Grasp of the hand, thumb-index finger pair pinch. The treatment course was the same as that of the electroacupuncture group.

干预措施: low-frequency acupoint electrical stimulation (Drug)

结局指标

主要结局

sEMG eigenvalues

时间窗: Three weeks

sEMG eigenvalues: two main aspects, maximum value (MAX), and root mean square value (RMS). MAX reflects the maximum contraction strength of the measured muscle. RMS is the root mean square of the EMG transient amplitude over time, which reflects the average change in EMG signal and is therefore used as an evaluation of muscle contraction performance.

次要结局

  • CSS score(Three weeks)
  • Brunnstrom's method of motor function evaluation(Three weeks)
  • Modified Ashworth Scale(Three weeks)
  • Lindmark hand function score(Three weeks)
  • Lovett muscle strength classification(Three weeks)

研究者

发起方
Xue Xia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xue Xia

Graduate

Heilongjiang University of Chinese Medicine

研究点 (1)

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