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临床试验/NCT07140406
NCT07140406进行中(未招募)不适用

Three-dimensional Motion Capture System Combined With sEMG Was Used to Evaluate the Effect of Different Firebone Acupuncture Strategies on Upper Limb Function in Stroke Patients

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
105
试验地点
1
主要终点
Root mean square(RMS) of surface electromyography(sEMG)

研究概览

简要总结

Objective: To explore the clinical efficacy of different needling strategies with moxibustion needles on upper limb function in post-stroke patients. Method: 105 patients with upper limb dysfunction after stroke were randomly divided into an extensor treatment group, a flexor treatment group, and a control group, with 35 patients in each group. Patients in the extensor treatment group were treated with extensor group moxibustion, patients in the flexor treatment group were treated with flexor group moxibustion, and patients in the control group were treated with conventional moxibustion. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before and after treatment, and determine the clinical efficacy. Result: Moxibustion therapy with moxibustion is helpful in improving upper limb dysfunction in stroke patients, safe and reliable, and worthy of application. The efficacy of needling the flexor muscle group with moxibustion is better than that of needling the extensor muscle group and conventional acupuncture, providing certain evidence and guidance for the selection of moxibustion sites in clinical practice.

详细描述

105 patients with upper limb dysfunction after stroke were selected according to the inclusion criteria and randomly divided into an extensor treatment group, a flexor treatment group, and a control group of 35 cases each. The patients in the extensor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the extensor muscle group (triceps brachii, forearm extensor muscle group), the patients in the flexor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the flexor muscle group (biceps brachii, forearm flexor muscle group), and the patients in the control group were treated with routine rehabilitation training+routine acupuncture and moxibustion+routine millifire needle acupuncture. The treatment was administered once every other day with a moxibustion needle for a total of 4 weeks. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, changes in MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before, after one treatment, and after 4 weeks of treatment. Calculate joint angles and motion distances through spatial coordinates, and apply RMS MF、CC、 Coherence analysis quantifies muscle strength, muscle tension, fatigue, and coordination.

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meet the diagnostic criteria.
  • •The patient had a first stroke and the course of disease was 15 days to 12 months.
  • •With unilateral disease, the muscular tone assessed by the modified Ashworth scale of upper limb was Ⅰ/Ⅰ+/Ⅱ/Ⅲ level ,Brunnstrom stage in upper limb was Ⅲ/Ⅳ/Ⅴ, Upper limb muscle strength is greater than or equal to grade
  • •Age 18-70 years old.
  • •Have not taken Chinese or Western medicine sedatives muscle relaxants or any drugs that have an impact on muscle tone recently.
  • •Clear consciousness stable vital signs no other acute diseases and serious complications.
  • •Patients or family members agree to accept this clinical study and have signed informed consent.

排除标准

  • •Bilateral disease.
  • •History of serious injury or disease of other upper limb nerves muscles or bones.
  • •Patients with severe cervical spondylosis and hypertension.
  • •Patients with audiovisual abnormalities severe cognitive impairment and mental diseases who cannot cooperate with the examination.
  • •Patients with tumor and severe malnutrition.
  • •There are contraindications for needle treatment such as extreme hunger tension infectious diseases skin collapse etc.

研究组 & 干预措施

Flexed muscle Milli-fire needle

Experimental

Patients in the flexor treatment group received conventional rehabilitation training, conventional acupuncture, and moxibustion with fine fire needles on the flexor muscle groups (biceps brachii and forearm flexor muscle groups).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: conventional rehabilitation training (Other)

Flexed muscle Milli-fire needle

Experimental

Patients in the flexor treatment group received conventional rehabilitation training, conventional acupuncture, and moxibustion with fine fire needles on the flexor muscle groups (biceps brachii and forearm flexor muscle groups).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: conventional acupuncture (Other)

Flexed muscle Milli-fire needle

Experimental

Patients in the flexor treatment group received conventional rehabilitation training, conventional acupuncture, and moxibustion with fine fire needles on the flexor muscle groups (biceps brachii and forearm flexor muscle groups).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: Acupuncture with the milli-needle fire-puncture on flexor muscle groups (Other)

Extensor muscle Milli-fire needle

Experimental

The patients in the extensor muscle treatment group received conventional rehabilitation training , conventional acupuncture and moxibustion with Milli-fire needle on the extensor muscle groups (triceps brachii, forearm extensor muscles).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: conventional rehabilitation training (Other)

Extensor muscle Milli-fire needle

Experimental

The patients in the extensor muscle treatment group received conventional rehabilitation training , conventional acupuncture and moxibustion with Milli-fire needle on the extensor muscle groups (triceps brachii, forearm extensor muscles).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: conventional acupuncture (Other)

Extensor muscle Milli-fire needle

Experimental

The patients in the extensor muscle treatment group received conventional rehabilitation training , conventional acupuncture and moxibustion with Milli-fire needle on the extensor muscle groups (triceps brachii, forearm extensor muscles).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: Acupuncture with the milli-needle fire-puncture on extensor muscle groups (Other)

Control group

Active Comparator

Patients in the control group received conventional rehabilitation training, conventional acupuncture, and conventional moxibustion with Milli-fire needle.The acupuncture points for fire needle puncture are commonly used ones on the upper limbs.The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: conventional rehabilitation training (Other)

Control group

Active Comparator

Patients in the control group received conventional rehabilitation training, conventional acupuncture, and conventional moxibustion with Milli-fire needle.The acupuncture points for fire needle puncture are commonly used ones on the upper limbs.The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: conventional acupuncture (Other)

Control group

Active Comparator

Patients in the control group received conventional rehabilitation training, conventional acupuncture, and conventional moxibustion with Milli-fire needle.The acupuncture points for fire needle puncture are commonly used ones on the upper limbs.The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

干预措施: Conventional needle puncture with a fire needle (Other)

结局指标

主要结局

Root mean square(RMS) of surface electromyography(sEMG)

时间窗: 4 weeks

Using sEMG the EMG of the upper limb muscles is collected including RMS

次要结局

  • Fugl-Meyer Assessment Upper Extremity Scale(FMA-UE)(4 weeks)
  • RMS of sEMG(first day)
  • Mean Frequency (MF)of SEMG(4 weeks)
  • Joint angle(4 weeks)
  • Motion distance(4 weeks)
  • Modified Ashworth Scale(MAS)(4 weeks)
  • Joint angle(first day)
  • Mean Frequency (MF)of SEMG(first day)
  • Motion distance(first day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZhangZhaohui

Acupuncture and moxibustion therapist

Qilu Hospital of Shandong University

研究点 (1)

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