{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T14:53:10Z","timestamp":1774968790981,"version":"3.50.1"},"reference-count":43,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2024,9,24]],"date-time":"2024-09-24T00:00:00Z","timestamp":1727136000000},"content-version":"unspecified","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Fujian Eyas Talent Program Project","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"DOI":"10.13039\/501100001809","name":"the National Natural Science Fund of China","doi-asserted-by":"crossref","award":["82074512"],"award-info":[{"award-number":["82074512"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,9,9]]},"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Aphasia is a common dysfunction among patients with stroke that can severely affect daily life. Listening to the \u2018five-tone\u2019 melodies of traditional Chinese medicine can improve some of the language functions of patients with post-stroke aphasia; however, passive listening may limit its clinical efficacy. In this study, we transform the passive listening five-tone melodic therapy of traditional Chinese medicine into an active five-tone speech therapy. This randomised controlled trial aims to investigate the clinical efficacy of active five-tone speech therapy in the treatment of post-stroke aphasia, such as language function, daily communication ability and communication efficiency, as well as investigate the therapeutic mechanism of this innovative therapy by electroencephalogram and MRI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>The study is a multicentric, randomised, parallel-assignment, single-blind treatment study. 70 participants will be recruited from the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine and the Third People\u2019s Hospital Affiliated to Fujian University of Traditional Chinese Medicine and randomly assigned to two groups, the five-tone speech therapy group and the control group, at a 1:1 ratio. The control group will receive 20 sessions of conventional speech-language therapy, while the five-tone speech therapy group will receive 20 sessions of five-tone speech therapy in addition to conventional speech-language therapy. The primary outcome measure for this study will be the score on Western Aphasia Battery. Secondary outcomes include communicative abilities in daily living, percentage of correct information units and correct information units per minute, as well as resting-state electroencephalogram, event-related potentials and MRI data. All outcomes will be evaluated at 0 weeks (before intervention) and at 4 weeks (after 20 intervention sessions).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Ethical approval of this study was granted by the ethics committees of the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine (2023KY-009-01) and the Third People\u2019s Hospital Affiliated to Fujian University of Traditional Chinese Medicine (2023-kl-010). Recruitment commenced on 24 April 2023. Informed consent will be obtained from all participants of the trial (or from their legal guardians, where applicable). The outcomes of the trial will be disseminated through peer-reviewed publications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ChiCTR2300069257.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-082282","type":"journal-article","created":{"date-parts":[[2024,9,24]],"date-time":"2024-09-24T13:50:46Z","timestamp":1727185846000},"page":"e082282","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Clinical efficacy and therapeutic mechanism of active \u2018five-tone\u2019 speech therapy compared with conventional speech-language therapy for treatment of post-stroke aphasia: protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4282-4318","authenticated-orcid":false,"given":"Mengxue","family":"Wang","sequence":"first","affiliation":[{"name":"Fujian University of Traditional Chinese Medicine, Fuzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinglei","family":"Ni","sequence":"additional","affiliation":[{"name":"Fujian University of Traditional Chinese Medicine, Fuzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bingbing","family":"Lin","sequence":"additional","affiliation":[{"name":"Fujian University of Traditional Chinese Medicine, Fuzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia","family":"Huang","sequence":"additional","affiliation":[{"name":"Fujian University of Traditional Chinese Medicine, Fuzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,9,24]]},"reference":[{"key":"2025101813064914000_14.9.e082282.1","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1044\/2018_AJSLP-18-0136","article-title":"Prospective Investigation of Incidence and Co-Occurrence of Dysphagia, Dysarthria, and Aphasia Following Ischemic Stroke","volume":"28","author":"Stipancic","year":"2019","journal-title":"Am J Speech Lang Pathol"},{"key":"2025101813064914000_14.9.e082282.2","doi-asserted-by":"publisher","DOI":"10.1111\/ene.14385"},{"key":"2025101813064914000_14.9.e082282.3","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1159\/000524206","article-title":"Incidence of Aphasia in Ischemic Stroke","volume":"56","author":"Gr\u00f6nberg","year":"2022","journal-title":"Neuroepidemiology"},{"key":"2025101813064914000_14.9.e082282.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.apmr.2016.03.006"},{"key":"2025101813064914000_14.9.e082282.5","doi-asserted-by":"publisher","DOI":"10.1155\/2022\/7977433"},{"key":"2025101813064914000_14.9.e082282.6","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1177\/17474930211017807","article-title":"Treatment of post-stroke aphasia: A narrative review for stroke neurologists","volume":"16","author":"Vitti","year":"2021","journal-title":"Int J Stroke"},{"key":"2025101813064914000_14.9.e082282.7","doi-asserted-by":"crossref","DOI":"10.1097\/MD.0000000000016629","article-title":"Assessment of the quality and content of clinical practice guidelines for post-stroke rehabilitation of aphasia","volume":"98","author":"Wang","year":"2019","journal-title":"Medicine (Baltimore)"},{"key":"2025101813064914000_14.9.e082282.8","first-page":"15","article-title":"Neurological Rehabilitation Group of the Neurology Branch of the Chinese Medical Association, Cerebrovascular Disease Committee of the Chinese Society of Rehabilitation Medicine, China Rehabilitation Research Center Expert Consensus on Clinical Management of Post-Stroke Aphasia","volume":"28","year":"2022","journal-title":"Rehab Theory Pract China"},{"key":"2025101813064914000_14.9.e082282.9","first-page":"692","article-title":"Clinical observation on acupuncture combined with rehabilitation training for dysphagia after ischemic stroke","volume":"37","author":"Cai","year":"2021","journal-title":"J Pract Chin Med"},{"key":"2025101813064914000_14.9.e082282.10","first-page":"2723","article-title":"A review of clinical studies on post-stroke aphasia in Chinese medicine","volume":"15","author":"Liu","year":"2017","journal-title":"J Integr Cardiovasc Cerebrovasc Dis"},{"key":"2025101813064914000_14.9.e082282.11","first-page":"4299","article-title":"Progress, problems and analysis of strategies of clinical research on insomnia based on the five tones theory of Chinese medicine","volume":"24","author":"Fan","year":"2022","journal-title":"World Sci Technol - Modern of Chin Med"},{"key":"2025101813064914000_14.9.e082282.12","first-page":"2045","article-title":"Diagnosis and treatment of tinnitus based on the twenty-five tones theory","volume":"37","author":"Li","year":"2022","journal-title":"J Trad Chin Med"},{"key":"2025101813064914000_14.9.e082282.13","unstructured":"Anonymous . 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Nanjing Medical University, 2019."},{"key":"2025101813064914000_14.9.e082282.25","doi-asserted-by":"crossref","DOI":"10.3389\/fnhum.2014.00592","article-title":"The Combination of Rhythm and Pitch Can Account for the Beneficial Effect of Melodic Intonation Therapy on Connected Speech Improvements in Broca\u2019s Aphasia","volume":"8","author":"Zumbansen","year":"2014","journal-title":"Front Hum Neurosci"},{"key":"2025101813064914000_14.9.e082282.26","doi-asserted-by":"publisher","DOI":"10.1044\/jshr.3602.338"},{"key":"2025101813064914000_14.9.e082282.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuroimage.2003.12.030"},{"key":"2025101813064914000_14.9.e082282.28","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1007\/s12021-016-9299-4","article-title":"DPABI: Data Processing & Analysis for (Resting-State) Brain Imaging","volume":"14","author":"Yan","year":"2016","journal-title":"Neuroinform"},{"key":"2025101813064914000_14.9.e082282.29","article-title":"DPARSF: A MATLAB Toolbox for \u201cPipeline\u201d Data Analysis of Resting-State fMRI","volume":"4","author":"Chao-Gan","year":"2010","journal-title":"Front Syst Neurosci"},{"key":"2025101813064914000_14.9.e082282.30","doi-asserted-by":"publisher","DOI":"10.1002\/mrm.20695"},{"key":"2025101813064914000_14.9.e082282.31","doi-asserted-by":"crossref","first-page":"183","DOI":"10.5853\/jos.2020.05015","article-title":"Current Approaches to the Treatment of Post-Stroke Aphasia","volume":"23","author":"Fridriksson","year":"2021","journal-title":"J Stroke"},{"key":"2025101813064914000_14.9.e082282.32","doi-asserted-by":"crossref","unstructured":"Cherney LR , Carpenter J . 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