The Efficacy of Integrated Rehabilitation for Post-Stroke Anxiety: Study Protocol for a Prospective, Multicenter, Randomized Controlled Trial

BACKGROUND: Post-stroke anxiety (PSA) remains a challenging medical problem. Integrated rehabilitation involves a combination of traditional Chinese medicine (TCM) and Western conventional rehabilitation techniques. Theoretically, integrated rehabilitation is likely to have significant advantages in treating PSA. Nevertheless, the therapeutic effect of integrated rehabilitation needs to be verified based on large-scale trials with sound methodology. Thus, the aim of this trial is to assess the efficacy and safety of integrated rehabilitation on PSA. METHODS: The study is a prospective, multicenter, randomized, controlled trial involving 188 PSA patients from four clinical centers in China. Eligible participants will be randomly divided into the integrated rehabilitation group or the standard care group. Participants in the integrated rehabilitation group will receive a combination of TCM and Western conventional rehabilitation methods, including acupuncture, repeated transcranial magnetic stimulation, traditional Chinese herbal medicine, and standard care. The primary outcome will be the Hamilton Anxiety Rating Scale (HAM-A). The secondary outcomes will include the Self-Rating Anxiety Scale (SAS), the Activities of Daily Living (ADL) scale, the Montreal Cognitive Assessment (MoCA) scale, the simplified Fugl–Meyer Assessment of motor function (FMA) scale, and the Pittsburgh Sleep Quality Index (PSQI). Outcome measurements will be performed at baseline, at the end of the 4-week treatment and the 8-week follow-up. CONCLUSION: Results of this trial will ascertain the efficacy and safety of integrated rehabilitation on PSA, thereby providing evidence regarding integrated rehabilitation strategies for treating PSA. It will also promote up-to-date evidence for patients, clinicians, and policy-makers. TRIAL REGISTRATION: ClinicalTrials.gov NCT05147077.