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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial

Authors: Jia Huang, Zhengkun Lin, Qin Wang, Feiwen Liu, Jiao Liu, Yunhua Fang, Shanjia Chen, Xiaoxuan Zhou, Wenjun Hong, Jinsong Wu, Natalia Madrigal-Mora, Guohua Zheng, Shanli Yang, Jing Tao, Lidian Chen

Published in: Trials | Issue 1/2015

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Abstract

Background

Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI.

Methods/Design

A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period).

Discussion

This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages.

Trial registration

This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872) on 23 June 2014.
Appendix
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Metadata
Title
The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
Authors
Jia Huang
Zhengkun Lin
Qin Wang
Feiwen Liu
Jiao Liu
Yunhua Fang
Shanjia Chen
Xiaoxuan Zhou
Wenjun Hong
Jinsong Wu
Natalia Madrigal-Mora
Guohua Zheng
Shanli Yang
Jing Tao
Lidian Chen
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0795-x

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