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

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...

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Autores principales: Huang, Jia, Lin, Zhengkun, Wang, Qin, Liu, Feiwen, Liu, Jiao, Fang, Yunhua, Chen, Shanjia, Zhou, Xiaoxuan, Hong, Wenjun, Wu, Jinsong, Madrigal-Mora, Natalia, Zheng, Guohua, Yang, Shanli, Tao, Jing, Chen, Lidian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485558/
https://www.ncbi.nlm.nih.gov/pubmed/26077459
http://dx.doi.org/10.1186/s13063-015-0795-x
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author Huang, Jia
Lin, Zhengkun
Wang, Qin
Liu, Feiwen
Liu, Jiao
Fang, Yunhua
Chen, Shanjia
Zhou, Xiaoxuan
Hong, Wenjun
Wu, Jinsong
Madrigal-Mora, Natalia
Zheng, Guohua
Yang, Shanli
Tao, Jing
Chen, Lidian
author_facet Huang, Jia
Lin, Zhengkun
Wang, Qin
Liu, Feiwen
Liu, Jiao
Fang, Yunhua
Chen, Shanjia
Zhou, Xiaoxuan
Hong, Wenjun
Wu, Jinsong
Madrigal-Mora, Natalia
Zheng, Guohua
Yang, Shanli
Tao, Jing
Chen, Lidian
author_sort Huang, Jia
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0795-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-44855582015-07-01 The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial Huang, Jia Lin, Zhengkun Wang, Qin Liu, Feiwen Liu, Jiao Fang, Yunhua Chen, Shanjia Zhou, Xiaoxuan Hong, Wenjun Wu, Jinsong Madrigal-Mora, Natalia Zheng, Guohua Yang, Shanli Tao, Jing Chen, Lidian Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0795-x) contains supplementary material, which is available to authorized users. BioMed Central 2015-06-16 /pmc/articles/PMC4485558/ /pubmed/26077459 http://dx.doi.org/10.1186/s13063-015-0795-x Text en © Huang et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Huang, Jia
Lin, Zhengkun
Wang, Qin
Liu, Feiwen
Liu, Jiao
Fang, Yunhua
Chen, Shanjia
Zhou, Xiaoxuan
Hong, Wenjun
Wu, Jinsong
Madrigal-Mora, Natalia
Zheng, Guohua
Yang, Shanli
Tao, Jing
Chen, Lidian
The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
title The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
title_full The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
title_fullStr The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
title_full_unstemmed The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
title_short The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
title_sort effect of a therapeutic regimen of traditional chinese medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4485558/
https://www.ncbi.nlm.nih.gov/pubmed/26077459
http://dx.doi.org/10.1186/s13063-015-0795-x
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