Community-applied research of a traditional Chinese medicine rehabilitation scheme on Broca’s aphasia after stroke: study protocol for a randomized controlled trial

Abstract

BackgroundAphasia is a common and severely disabling complication in stroke patients. It usually brings about lower rates of functional recovery, longer rehabilitation length of stay (LOS), and significantly poorer LOS efficiency (LOS-Eff), resulting in higher rehabilitation costs compared to patients without aphasia. It also decreases the quality of life and increases the mortality of stroke patients. The evidence currently available suggests that the effect of acupuncture combined with language training for apoplectic aphasia is statistically better than speech and language therapy (SLT) alone, but there remains a lack of high-quality randomized controlled trials. Acupuncture combined with language training is relatively low-cost and especially suitable for community-based rehabilitation for aphasia patients after stroke, taking its medical and health facilities which are always deficient in manpower and material resources into account. The aim of the present study is to develop an effective standard therapeutic program for apoplectic aphasia in communities.Methods/DesignIn a randomized controlled clinical trial with blinded assessment, 290 eligible patients with aphasia due to stroke will be randomly allocated into a control group or an experimental group. The course of this trial will comprise a 4-week intervention and a 12-week follow-up period. Five assessment points, including baseline, 2 and 4 weeks after treatment, 6 and 12 weeks after follow-up, are set to dynamically observe the changes of curative effects. Primary outcome measures are the differences in the score on both the China rehabilitation research center aphasia examination (CRRCAE) and Boston diagnostic aphasia examination - Chinese version (BDAE-C) after intervention and follow-up. The Modified Barthel Index (MBI), 36-Item Short Form Health Survey (SF-36), and results of blood oxygen level dependent-functional magnetic resonance imaging (BOLD-fMRI) examination are considered as the secondary outcome measures. Other outcomes will include rate of adverse events and economic effects.DiscussionIf the outcome is positive, this project will offer a low-cost appropriate technology for community health centers (CHCs) in the rehabilitation of aphasia patients after stroke, and could be implemented on a large scale, both in China and worldwide.Trial registrationChinese Clinical Trial Registry: ChiCTR-TRC-13003703. Registration date: 18 October 2013.

Patient with stroke: hospital discharge planning, functionality and quality of life

“…S 12 (18) An ongoing experimental study that started in November 2013, and whose last patient was included on August, 1st, 2015. A study with acupuncture acting as an experimental variable in the therapeutic process, which comprises speech/language therapy plus initial therapy (for patients with post-stroke aphasia).…”

“…E 12 (18) Community-applied research of a traditional Chinese medicine rehabilitation scheme on Broca's aphasia after stroke: study protocol for a randomized controlled trial.…”

Efficacy of Tiaoqiheying decoction in the treatment of spasmodic pain and lipid metabolism after acute ischemic stroke

“…In a community-applied study, Tao et al. 19 found that the application of traditional Chinese medicine to rehabilitation significantly improved Broca’s aphasia after stroke. In the present study, we also observed that Tiaoqiheying decoction was effective and safe in the treatment of stroke.…”

Severidad de la afasia y condición funcional en pacientes con ictus

“…15 Varios autores consideran la afasia como factor predictor de mal pronóstico de recuperación, y otros la han asociado a una peor condición funcional con serias implicaciones para realizar las actividades de la vida diaria, como la comunicación pública y con otras personas, el uso del teléfono, el trato con dinero entre otros aspectos. 1,7,[10][11][12] Los resultados de nuestro estudio apoyan tal referencia, existe asociación entre la afasia y la condición funcional. Sin embargo, intentamos ir más allá, tratando de definir hasta dónde el grado de severidad de la afasia puede hacer diferente el grado de discapacidad funcional.…”