互动式头针对中风后下肢运动功能和步态的影响:一项多中心、随机、对照临床研究

Shao-hua ZHANG; Yu-long WANG; Chun-xia ZHANG; Chun-ping ZHANG; Peng XIAO; Qian-feng LI; Wei-rong LIANG; Xiao-hua PAN; Ming-chao ZHOU

doi:10.1007/s11655-021-3525-0

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互动式头针对中风后下肢运动功能和步态的影响:一项多中心、随机、对照临床研究

Original Article | Updated：2022-06-27

- 互动式头针对中风后下肢运动功能和步态的影响:一项多中心、随机、对照临床研究
- Effects of Interactive Dynamic Scalp Acupuncture on Motor Function and Gait of Lower Limbs after Stroke:A Multicenter, Randomized, Controlled Clinical Trial
- Chinese Journal of Integrative Medicine 2022年28卷第6期页码：483-491
- Affiliations：
  
  1.Department of Rehabilitation, Dapeng New District Nan'ao People's Hospital, Shenzhen, Guangdong Province (518121),China
  2.Department of Rehabilitation Medicine, Shenzhen Second People's Hospital, Shenzhen, Guangdong Province (518037), China
  3.Department of Rehabilitation Medicine,Shenzhen Hospital of Guangzhou University of Chinese Medicine, Shenzhen, Guangdong Province (518034), China
- Author bio：
  
  Prof. WANG Yu-long, E-mail:ylwang66@126.com
- Funds：
  
  Medical Research Fund of Guangdong, China(A2020448);Special Fund Support Project for Industrial Development in Dapeng New District, Shenzhen of Guangdong Province, China(YL202001-16);Medical and Health Research Fund Project of Medical and Health Group in Dapeng New District, Shenzhen, Guangdong Province, China(2019JTYM003;2019JTYM004)
- DOI：10.1007/s11655-021-3525-0
  中图分类号：
- 纸质出版日期：2022-06-01，
  
  网络出版日期：2021-12-15，
  
  录用日期：2020-12-25
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Shao-hua ZHANG, Yu-long WANG, Chun-xia ZHANG, 等. 互动式头针对中风后下肢运动功能和步态的影响:一项多中心、随机、对照临床研究[J]. Chinese Journal of Integrative Medicine, 2022,28(6):483-491.

Shao-hua ZHANG, Yu-long WANG, Chun-xia ZHANG, et al. Effects of Interactive Dynamic Scalp Acupuncture on Motor Function and Gait of Lower Limbs after Stroke:A Multicenter, Randomized, Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(6):483-491.
Shao-hua ZHANG, Yu-long WANG, Chun-xia ZHANG, 等. 互动式头针对中风后下肢运动功能和步态的影响:一项多中心、随机、对照临床研究[J]. Chinese Journal of Integrative Medicine, 2022,28(6):483-491. DOI： 10.1007/s11655-021-3525-0.

Shao-hua ZHANG, Yu-long WANG, Chun-xia ZHANG, et al. Effects of Interactive Dynamic Scalp Acupuncture on Motor Function and Gait of Lower Limbs after Stroke:A Multicenter, Randomized, Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(6):483-491. DOI： 10.1007/s11655-021-3525-0.

摘要

目的:

探讨互动式头针(IDSA)、简单联合疗法(SCT)和传统头针(TSA)对脑卒中后偏瘫患者下肢运动功能和步态的影响.

方法:

将231例脑卒中后偏瘫患者随机分为IDSA组(78例)、SCT组(78例)和TSA组(75例). IDSA及SCT组患者均行头针(SA)和下肢机器人训练(LLRT). TSA组患者行头针治疗

但未行下肢机器人训练. 每日1次

每周6天

总疗程为8周. 分别于治疗前、治疗后1、2个月及随访1、2个月进行评价. 主要观察指标为下肢Fugl-Meyer评估(FMA-LE)、Berg平衡量表(BBS)、改良Barthel指数(MBI)和6分钟步行试验(6MWT). 次要观察指标包括步频(SF)、步幅(SL)、步幅宽度(SW)、患侧足角(ASFA)、患髋(PROM-H)、膝关节(PROM-K)和踝关节(PROM-A)被动活动范围(PROM). 观察治疗后2个月内不良事件进行安全性评价.

结果:

有19例患者退出试验

其中IDSA组8例

SCT组5例

TSA组6例. IDSA组患者治疗8周及第2次随访时FMA-LE、BBS、6MWT、MBI评分均较SCT及TSA组明显升高(

0.05或

0.01). 与治疗前比较

三组患者在治疗1、2个月及第2次随访时BBS及MBI评分等级分布均有明显改善(

0.05或

0.01). 治疗8周后

IDSA组SF、PROM-H、PROM-K、PROM-A均明显高于SCT及TSA组(

0.05或

0.01)

ASFA明显低于SCT组(

0.05). 与SCT、TSA组比较

IDSA组第1次随访时SF、SL、PROM-K及PROM-A明显升高

ASFA明显降低(

0.05或

0.01). 第2次随访时

IDSA组SF、SL、PROM-K、PROM-A均明显高于SCT组(

0.05或

0.01). 治疗8周后SCT组SF明显高于TSA组(

0.05)

第2次随访时PROM-K及PROM-A明显高于TSA组(

0.05).

结论:

IDSA对脑卒中后患者下肢运动功能和行走能力的影响优于SCT和TSA. SCT组与TSA组具有可比性

但在改善下肢活动范围方面似乎疗效更优.

Abstract

Objective:

To evaluate the effects of interactive dynamic scalp acupuncture (IDSA)

simple combination therapy (SCT)

and traditional scalp acupuncture (TSA) on motor function and gait of the lower limbs in post-stroke hemiplegia patients.

Methods:

A total of 231 patients with post-stroke hemiplegia was randomly divided into IDSA (78 cases)

SCT (78 cases)

and TSA (75 cases) groups by a random number table. Scalp acupuncture (SA) and lower-limb robot training (LLRT) were both performed in the IDSA and SCT groups. The patients in the TSA group underwent SA and did not receive LLRT. The treatment was administered once daily and 6 times weekly for 8 continuous weeks

each session lasted for 30 min. The primary outcome measures included Fugl-Meyer Assessment of the Lower Extremity (FMA-LE)

Berg Balance Scale (BBS)

Modified Barthel Index (MBI)

and 6-min walking test (6MWT). The secondary outcome measures included stride frequency (SF)

stride length (SL)

stride width (SW)

affected side foot angle (ASFA)

passive range of motion (PROM) of the affected hip (PROM-H)

knee (PROM-K) and ankle (PROM-A) joints. The patients were evaluated before treatment

at 1- and 2-month treatment

and 1-

and 2-month follow-up visits

respectively. Adverse events during 2-month treatment were observed.

Results:

Nineteen patients withdrew from the trial

with 8 in the IDSA group

5 in the SCT group

and 6 in the TSA group. The FMA-LE

BBS

6MWT and MBI scores in the IDSA group were significantly increased after 8-week treatment and 2 follow-up visits compared with the SCT and TSA groups (

0.05 or

0.01). Compared with pre-treatment

the grade distribution of BBS and MBI scores in the 3 groups were significantly improved at 1

2-month treatment and 2 follow-up visits (

0.05 or

0.01). The SF

PROM-H

PROM-K and PROM-A in the IDSA group was significantly increased compared with the SCT and TSA groups after 8-week of treatment (

0.05 or

0.01). Compared with the SCT group

ASFA of the IDSA group was significantly reduced after 8-week of treatment (

0.05). SF

PROM-K and PROM-A were significantly increased at the 2nd follow-up visit whereas the ASFA was significantly reduced in the IDSA group compared with the SCT groups at 1st follow-up visit (

0.05 or

0.01). The SF was significantly increased in the SCT group compared with the TSA group after 8-week treatment (

0.05). Compared with the TSA group

PROM-K

PROM-A were significantly increased at the 2nd follow-up visit (

0.05).

Conclusions:

The effects of IDSA on lower-limb motor function and walking ability of post-stroke patients were superior to SCT and TSA. The SCT was comparable to TSA treatment

and appeared to be superior in improving the motion range of the lower extremities. (Registration No. ChiCTR1900027206)

关键词

Keywords

interactive dynamic scalp acupuncturestrokedyskinesialower extremity motor abilitygaitself-care capabilityrandomized controlled clinical trial

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