Clinical efficacy and therapeutic mechanism of active 'five-tone' speech therapy compared with conventional speech-language therapy for treatment of post-stroke aphasia: protocol for a randomised controlled trial.

Introduction: Aphasia is a common dysfunction among patients with stroke that can severely affect daily life. Listening to the 'five-tone' 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.

Methods And Analysis: 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's 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).

Ethics And Dissemination: 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's 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.

Trial Registration Number: ChiCTR2300069257.