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      Applying Tai Chi as a rehabilitation program for stroke patients in the recovery phase: study protocol for a randomized controlled trial

      research-article
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      Trials
      BioMed Central
      Recovery phase, Rehabilitation, Stroke, Tai Chi

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          Abstract

          Background

          As the second commonest cause of death and a major cause of disability worldwide, stroke has greatly influenced patients’ quality of life and created a huge public health burden. As a special form of physical activity that has been widely practiced in China, and even throughout the world, Tai Chi may be favorable for the rehabilitation of stroke patients. Several studies have been conducted to investigate the rehabilitative effects of Tai Chi for stroke patients, but none of them have been focused on the recovery phase (2 to 24 weeks) of stroke.

          Methods/design

          This study is an assessor-blinded randomized controlled trial. A total of 50 eligible participants will be randomly assigned to either a control group or a Tai Chi group. Patients in the control group will receive standard, conventional rehabilitation therapies, and a combination of Tai Chi and conventional rehabilitation programs will be applied in the Tai Chi group. The recovery of motor impairment, functional activity and balance abilities as measured with the Fugl-Meyer Assessment, Barthel Index and Berg Balance Scale will be assessed as primary outcome measures. The secondary outcome measures to be used are the scores on the Stroke-Specific Quality of Life Scale, the National Institutes of Health Stroke Scale and the objective parameters of the RSscan footscan gait system. All assessments will be conducted at baseline, 4 weeks after the rehabilitation course and at the end of 3-month follow-up.

          Discussion

          The results of this study will provide preliminary evidence regarding the efficacy and feasibility of Tai Chi as an additional rehabilitative program for stroke patients in the recovery phase.

          Trial registration

          Chinese Clinical Trial Register ID: ChiCTR-TRC-13003661 (7 October 2013)

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          Most cited references27

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          Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review.

          In a recent study of 655 physical therapists working with a stroke population, the Berg Balance Scale (BBS) was identified as the most commonly used assessment tool across the continuum of stroke rehabilitation. Given the widespread popularity of the BBS, it is important to critically appraise the BBS for its use with a stroke population. The purposes of this study were to conduct a systematic review of the psychometric properties of the BBS specific to stroke and to identify strengths and weaknesses in its usefulness for stroke rehabilitation. Twenty-one studies examining the psychometric properties of the BBS with a stroke population were retrieved. Internal consistency was excellent (Cronbach alpha=.92-.98) as was interrater reliability (intraclass correlation coefficients [ICCs]=.95-.98), intrarater reliability (ICC=.97), and test-retest reliability (ICC=.98). Sixteen studies focused on validity and generally found excellent correlations with the Barthel Index, the Postural Assessment Scale for Stroke Patients, Functional Reach Test, the balance subscale of Fugl-Meyer Assessment, the Functional Independence Measure, the Rivermead Mobility Index (except for weight shift and step-up items), and gait speed. Berg Balance Scale scores predicted length of stay, discharge destination, motor ability at 180 days poststroke, and disability level at 90 days, but these scores were not predictive of falls. Eight studies focused on responsiveness; all reported moderate to excellent sensitivity. Three studies found floor or ceiling effects. The BBS is a psychometrically sound measure of balance impairment for use in poststroke assessment. Given the floor and ceiling effects, clinicians may want to use the BBS in conjunction with other balance measures.
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            Global variation in stroke burden and mortality: estimates from monitoring, surveillance, and modelling.

            Recent improvements in the monitoring and modelling of stroke have led to more reliable estimates of stroke mortality and burden worldwide. However, little is known about the global distribution of stroke and its relations to the prevalence of cardiovascular disease risk factors and sociodemographic and economic characteristics. National estimates of stroke mortality and burden (measured in disability-adjusted life years [DALYs]) were calculated from monitoring vital statistics, a systematic review of studies that report disease surveillance, and modelling as part of the WHO Global Burden of Disease programme. Similar methods were used to generate standardised measures of the national prevalence of cardiovascular risk factors. Risk factors other than diabetes and disease burden estimates were age-adjusted and sex-adjusted to the WHO standard population. There was a ten-fold difference in rates of stroke mortality and DALY loss between the most-affected and the least-affected countries. Rates of stroke mortality and DALY loss were highest in eastern Europe, north Asia, central Africa, and the south Pacific. National per capita income was the strongest predictor of mortality and DALY loss rates (p<0.0001) even after adjustment for cardiovascular risk factors (p<0.0001). Prevalences of cardiovascular risk factors measured at a national level were generally poor predictors of national stroke mortality rates and burden, although raised mean systolic blood pressure (p=0.028) and low body-mass index (p=0.017) predicted stroke mortality, and greater prevalence of smoking predicted both stroke mortality (p=0.041) and DALY-loss rates (p=0.034). Rates of stroke mortality and burden vary greatly among countries, but low-income countries are the most affected. Current measures of the prevalence of cardiovascular risk factors at the population level poorly predict overall stroke mortality and burden and do not explain the greater burden in low-income countries.
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              Development of a stroke-specific quality of life scale.

              Clinical stroke trials are increasingly measuring patient-centered outcomes such as functional status and health-related quality of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and responsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. Domains and items for the SS-QOL were developed from patient interviews. The SS-QOL, Short Form 36, Beck Depression Inventory, National Institutes of Health Stroke Scale, and Barthel Index were administered to patients 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by comparing domain scores with similar domains of established measures. Domain responsiveness was assessed with standardized effect sizes. All 12 domains of the SS-QOL were unidimensional. In the final 49-item scale, all domains demonstrated excellent internal reliability (Cronbach's alpha values for each domain >/=0.73). Most domains were moderately correlated with similar domains of established outcome measures (r2 range, 0.3 to 0.5). Most domains were responsive to change (standardized effect sizes >0.4). One- and 3-month SS-QOL scores were associated with patients' self-report of HRQOL compared with before their stroke (P<0.001). The SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in diverse stroke populations are needed.
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                Author and article information

                Contributors
                zhangyong_tcm@163.com
                luckyshitiancai@163.com
                happyzhouli85@sina.com
                zlck@live.com
                erpangzhi@126.com
                zouyihuai2004@163.com
                lee_zongheng@163.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                11 December 2014
                2014
                : 15
                : 1
                : 484
                Affiliations
                [ ]Department of Rehabilitation, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, No. 5, Haiyuncang, Dongcheng District, Beijing, 100700 China
                [ ]Department of Neurology and Stroke Center, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, No. 5, Haiyuncang, Dongcheng District, Beijing, 100700 China
                Article
                2377
                10.1186/1745-6215-15-484
                4295286
                25496342
                c19c2db9-07c5-4dac-bd3c-450451445e18
                © Zhang et al.; licensee BioMed Central. 2014

                This article is published under license to BioMed Central Ltd. 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.

                History
                : 5 June 2014
                : 24 November 2014
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2014

                Medicine
                recovery phase,rehabilitation,stroke,tai chi
                Medicine
                recovery phase, rehabilitation, stroke, tai chi

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