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Open Access Study protocol

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

Jing Tao1, Yunhua Fang1, Zhenkai Wu1, Ting Rao2, Yusheng Su2, Lili Lin2, Wei Liu2, Jinsong Wu2, Shanli Yang2, Guohua Zheng2 and Lidian Chen3*

Author Affiliations

1 Rehabilitation Medicine College, Fujian University of Traditional Chinese Medicine, No.1 Huatuo Road Shangjie Minhou, Fuzhou 350122, China

2 Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, No.1 Huatuo Road Shangjie Minhou, Fuzhou 350122, China

3 Fujian University of Traditional Chinese Medicine, No.1 Huatuo Road Shangjie Minhou, Fuzhou 350122, China

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Trials 2014, 15:290  doi:10.1186/1745-6215-15-290

Published: 21 July 2014

Abstract

Background

Aphasia 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/Design

In 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.

Discussion

If 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 registration

Chinese Clinical Trial Registry: ChiCTR-TRC-13003703. Registration date: 18 October 2013.

Keywords:
Aphasia; Stroke; Traditional Chinese medicine; Rehabilitation; Randomized controlled trial