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Open Access 01-12-2022 | Acupuncture | Study protocol

The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial

Authors: Shizhe Deng, Bomo Sang, Boxuan Li, Hai Lu, Lili Zhang, Guang Tian, Ting Hao, Yufeng Zhang, Lei Shi, Kaihang Sun, Te Ba, Feng Li, Ying Kong, Mengni Qin, Jianli Zhang, Xiaofeng Zhao, Zhihong Meng

Published in: Trials | Issue 1/2022

Abstract

Background

Motor aphasia after stroke is a common and intractable complication of stroke. Acupuncture and language training may be an alternative and effective approach. However, the efficacy of acupuncture and language training for motor aphasia after stroke has not been confirmed. The main objectives of this trial are to evaluate the effectiveness and safety of acupuncture and low-intensity, low-dose language training in treating ischemic motor aphasia after stroke from 15 to 90 days.

Methods

This is a multicenter randomized sham-controlled clinical trial. We will allocate 252 subjects aged between 45 and 75 years diagnosed with motor aphasia after stroke with an onset time ranging from 15 to 90 days into two groups randomly in a 1:1 ratio. Patients in the experimental group will be treated with “Xing-Nao Kai-Qiao” acupuncture therapy plus language training, and those in the control group will be treated with sham-acupoint (1 cun next to the acupoints) acupuncture therapy plus language training. All the patients will be given acupuncture and language training for 6 weeks, with a follow-up evaluation 6 weeks after the end of the treatment and 6 months after the onset time. The patients will mainly be evaluated using the Western Aphasia Battery and Chinese Functional Communication Profile, and the incidence of treatment-related adverse events at the 2nd, 4th, and 6th weeks of treatment will be recorded. The baseline characteristics of the patients will be summarized by group, the chi-squared test will be used to compare categorical variables, and repeated measures of analysis of variance or a linear mixed model will be applied to analyze the changes measured at different time points.

Discussion

The present study is designed to investigate the effectiveness and safety of traditional acupuncture therapy and language training in ischemic motor aphasia after stroke and explore the correlation between the treatment time and clinical effect of acupuncture. We hope our results will help doctors understand and utilize acupuncture combined with language training.

Trial registration

ChiCTR ChiCTR1900026740. Registered on 20 October 2019

Available only for authorised users

Wade DT, Hewer RL, David RM, Enderby PM. Aphasia after stroke: natural history and associated deficits. J Neurol Neurosurg Psychiatry. 1986;49(1):11–6. https://doi.org/10.1136/jnnp.49.1.11.CrossRefPubMedPubMedCentral

Wertz RT. Aphasia in acute stroke: incidence, determinants, and recovery. Ann Neurol. 1996;40(1):129–30. https://doi.org/10.1002/ana.410400125.CrossRefPubMed

Engelter ST, Gostynski M, Papa S, Frei M, Born C, DrSc VA-G, et al. Epidemiology of aphasia attributable to first ischemic stroke: incidence, severity, fluency, etiology, and thrombolysis. Stroke. 2006;37(6):1379–84. https://doi.org/10.1161/01.STR.0000221815.64093.8c.CrossRefPubMed

Zhang B, Han Y, Huang X, Liu Z, Li S, Chang J, et al. Acupuncture is effective in improving functional communication in post-stroke aphasia: a systematic review and meta-analysis of randomized controlled trials. Wien Klin Wochenschr. 2019;131(9-10):221–32. https://doi.org/10.1007/s00508-019-1478-5.CrossRefPubMed

Murray LL, Kim HY. A review of select alternative treatment approaches for acquired neurogenic disorders: relaxation therapy and acupuncture. Semin Speech Lang. 2004;25(02):133–49. https://doi.org/10.1055/s-2004-825651.CrossRefPubMed

Mu J, Fu LX, Lu YM, Ren YL, He JY, Qi YZ. Clinical observation on the Xing Nao Kai Qiao Acupuncture plus language rehabilitation training for motor aphasia caused by cerebral infarction: a report of 30 cases. J Tradit Chin Med. 2010;51:428–31.

Zhao Q. Clinical study of Xing Nao Kai Qiao acupuncture treatment on motor aphasia after stroke. J Sichuan Tradit Chin Med. 2011;9:120–1.

Wu Q, Hu XQ, Wen XY, Li FM, Fu WB. Clinical study of acupuncture treatment on motor aphasia after stroke. Technol Health Care. 2016;24(Suppl 2):S691–6. https://doi.org/10.3233/THC-161197.CrossRefPubMed

Pang Y, Wu LB, Liu DH. Acupuncture therapy for apoplectic aphasia: a systematic review. Zhongguo Zhen Jiu. 2010;30(7):612–6.PubMed

10.

Mu J, Fu LX, Lu YM, Ren YL, He JY, Qi YZ. The quality evaluation of domestic RCT literature on acupuncture treatment of aphasia after stroke. Liaoning J Tradit Chin Med. 2009;36:1581–3.

11.

Berube S, Hillis AE. Advances and innovations in aphasia treatment trials. Stroke. 2019;50:2977–84.CrossRef

12.

Greener J, Enderby P, Whurr R. Pharmacological treatment for aphasia following stroke. Cochrane Database Syst Rev. 2001:CD000424.

13.

Cotelli M, Manenti R, Ferrari C, Gobbi E, Macis A, Cappa SF. Effectiveness of language training and non-invasive brain stimulation on oral and written naming performance in primary progressive aphasia: a meta-analysis and systematic review. Neurosci Biobehav Rev. 2020;108:498–525. https://doi.org/10.1016/j.neubiorev.2019.12.003.CrossRefPubMed

14.

Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012:CD000425. https://doi.org/10.1002/14651858.CD000425.pub3.

15.

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in adults with aphasia after stroke. Cochrane Database Syst Rev. 2019:CD009760.

16.

Regier DA, Kaelber CT, Roper MT, Rae DS, Sartorius N. The ICD-10 clinical field trial for mental and behavioral disorders: results in Canada and the United States. Am J Psychiatry. 1994;151(9):1340–50. https://doi.org/10.1176/ajp.151.9.1340.

17.

Kertesz A. Western aphasia battery, ed 2. New York: The Psychological Corporation; 1982.

18.

Wang XR, Zhuo DH. Functional language communication ability test and its application in aphasia of apoplexy I: formulation of functional language communication ability test program. Chin J Rehabil Med. 1992;7:248–50.

19.

Goodlass H, Kaplan E. The assessment of aphasia and related disorders. In Hecaen and Albert 1979. Philadelphia: Lea & Febiger; 1982.

20.

Qiu W-H, Guan H-L, Chen Z-C, Yu Y, Wu H-X, Yu W-S, et al. Psychometric properties of the Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39 g). Top Stroke Rehabil. 2019;26(2):106–12. https://doi.org/10.1080/10749357.2018.1544842.CrossRefPubMed

21.

Hilari K, Byng S. Measuring quality of life in people with aphasia: the Stroke Specific Quality of Life Scale. Int J Lang Commun Disord. 2001;36(Suppl):86–91. https://doi.org/10.3109/13682820109177864.CrossRefPubMed

22.

Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–70.CrossRef

23.

Wu DR, Lai SL, Guo XF, Wen ZH, Liang WX. Preliminary evaluation of the measurement characteristics of TCM health scale. J Chin Integr Med. 2008;6(7):682–9. https://doi.org/10.3736/jcim20080705.CrossRef

24.

Sun Y, Xue SA, Zuo Z. Acupuncture therapy on apoplectic aphasia rehabilitation. J Tradit Chin Med. 2012;32(3):314–21. https://doi.org/10.1016/S0254-6272(13)60031-X.CrossRefPubMed

25.

Liu G, Sun JJ, Yang J, Zhang QP. “Xingnao Kaiyin acupuncture” combined with speech training for post-stroke aphasia. Zhongguo Zhen Jiu. 2019;39(4):355–8. https://doi.org/10.13703/j.0255-2930.2019.04.003.CrossRefPubMed

26.

Li G, Yang ES. An fMRI study of acupuncture-induced brain activation of aphasia stroke patients. Complement Ther Med. 2011;19(Suppl 1):S49–59. https://doi.org/10.1016/j.ctim.2010.11.004.CrossRefPubMed

27.

Liu S, Li M, Tang W, Wang G, Lv Y. An fMRI study of the effects on normal language areas when acupuncturing the Tongli (HT5) and Xuanzhong (GB39) acupoints. J Int Med Res. 2017;45(6):1961–75. https://doi.org/10.1177/0300060517720344.CrossRefPubMedPubMedCentral

28.

Chang J, Zhang H, Tan Z, Xiao J, Li S, Gao Y. Effect of electroacupuncture in patients with post-stroke motor aphasia: neurolinguistic and neuroimaging characteristics. Wien Klin Wochenschr. 2017;129(3-4):102–9. https://doi.org/10.1007/s00508-016-1070-1.CrossRefPubMed

29.

Gittler M, Davis AM. Guidelines for adult stroke rehabilitation and recovery. JAMA. 2018;319:820–1.CrossRef

30.

Tang HY, Tang W, Yang F, Wu WW, Shen GM. Efficacy of acupuncture in the management of post-apoplectic aphasia: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Altern Med. 2019;19(1):282. https://doi.org/10.1186/s12906-019-2687-1.CrossRefPubMedPubMedCentral

31.

Shewan CM, Kertesz A. Reliability and validity characteristics of the Western Aphasia Battery (WAB). J Speech Hear Disord. 1980;45(3):308–24. https://doi.org/10.1044/jshd.4503.308.CrossRefPubMed

32.

Tsapkini K, Vlahou CH, Potagas C. Adaptation and validation of standardized aphasia tests in different languages: lessons from the Boston Diagnostic Aphasia Examination - Short Form in Greek. Behav Neurol. 2010;22(3-4):111–9. https://doi.org/10.1155/2010/423841.CrossRefPubMedPubMedCentral

33.

Wang XR, Zhuo DH. The Chinese functional communication profile and its value in the evaluation of aphasia following stroke: II. Comparison with BDAE. Chin J Rehabil Med. 1993;8:60–3.

Title: The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial
Authors: Shizhe Deng
Bomo Sang
Boxuan Li
Hai Lu
Lili Zhang
Guang Tian
Ting Hao
Yufeng Zhang
Lei Shi
Kaihang Sun
Te Ba
Feng Li
Ying Kong
Mengni Qin
Jianli Zhang
Xiaofeng Zhao
Zhihong Meng
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Acupuncture
Stroke
Aphasia
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06280-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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