bmj open · the bobath program and the proprioceptive neuromuscular facilitation [18]. most tai chi...

For peer review only

Tai Chi for stroke rehabilitation: protocol for a systematic

review

Journal: BMJ Open

Manuscript ID bmjopen-2015-010866

Article Type: Protocol

Date Submitted by the Author: 14-Dec-2015

Complete List of Authors: Zhang, Yong; Dongzhimen Hospital; National Institute of Complementary Medicine Wang, Shanshan; Beijing University of Chinese Medicine, Department of International Communications Chen, Pei; Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Department of Neurology and Stroke Center Zhu, Xiaoshu; National Institute of Complementary Medicine Zhongheng, Lee; Beijing University of Chinese Medicine

<b>Primary Subject Heading</b>:

Complementary medicine

Secondary Subject Heading: Rehabilitation medicine

Keywords: tai chi, systematic review, protocol, Stroke < NEUROLOGY

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

BMJ Open on January 20, 2021 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2015-010866 on 16 June 2016. D

ownloaded from

http://bmjopen.bmj.com/


Tai Chi for stroke rehabilitation: protocol for a systematic review

Yong Zhang, 1,2,3,4 Shanshan Wang, 2,4 Pei Chen,3 Xiaoshu Zhu, 2 Zongheng Li 1 1 Department of Rehabilitation, Dongzhimen Hospital, the First Affiliated Hospital of Beijing

University of Chinese Medicine, Beijing, 100700, China 2 National Institute of Complementary Medicine, Western Sydney University, Sydney, New

South Wales, 2751, Australia 3 Department of Neurology and Stroke Center, Dongzhimen Hospital, the First Affiliated

Hospital of Beijing University of Chinese Medicine, Beijing, 100700, China 4 Department of International Communications, Beijing University of Chinese Medicine, Beijing,

100029, China Correspondence to: Dr. Zongheng Li, [email protected] Authors’ e-mail: Yong Zhang: [email protected] Shanshan Wang: [email protected] Pei Chen: [email protected] Xiaoshu Zhu: [email protected] Zongheng Li: [email protected]

Page 1 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

on January 20, 2021 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Abstract:

Introduction: Stroke has left a huge burden and significant workload for the whole world. As a special form of physical activity, Tai Chi is feasible for stroke rehabilitation. The objective of this review is to systematically evaluate the efficacy and safety of Tai Chi for the rehabilitation in stroke patients.

Methods and analysis: We will conduct a systematic search of the following electronic databases from their inception to October 31, 2015: MEDLINE, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), and China’s Dissertation Database. All relevant randomised controlled trials (RCTs) in English and Chinese will be included. The main outcomes will be patients’ changes of neurological functions and independence in activities of daily living. Adverse events, adherence, costs and cost effectiveness of Tai Chi will also be assessed. Two independent reviewers will work on study selection, data extraction and quality assessment. The Review manage 5.3 will be used for assessment of risk of bias, data synthesis and subgroup analysis.

Ethics and dissemination: This systematic review does not require formal ethical approval because all data will be analysed anonymously. Results will provide a general overview and evidence of the efficacy and safety of Tai Chi for stroke rehabilitation. Findings will be disseminated through peer-reviewed publications.

Trial registration number: PROSPERO 2015:CRD42015026999

Strengths and limitations of this study:

• There is only one systematic review involving Tai Chi for stroke rehabilitation published in 2012 without any update until now. With many new studies published within the past 3 years, the current systematic review will reassess the efficacy and safety of Tai Chi for stroke rehabilitation and will provide further clinical evidence for both clinicians and patients to make decisions in practising Tai Chi for stroke rehabilitation.

• One limitation of this systematic review is that language bias may exist as we will only include studies published in English and Chinese which will lead to some relevant studies in other languages missed.

• Another limitation is that significant heterogeneity may appear due to the various types of Tai Chi forms, styles, durations, and frequencies.

Page 2 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



INTRODUCTION

Description of the condition

Stroke has become the second most common cause of death and the major cause of disability worldwide [1]. It greatly impacts quality of life of survivors and is an immense public health burden [2]. With the population aging and lifestyle changing, the burden is projected to increase markedly during the next 20 years, especially in developing countries [3]. A recent study indicated that the rates of stroke mortality have decreased worldwide but the absolute number of new stroke patients, stroke survivors with functional disabilities, stroke related deaths, and the overall global burden of stroke were great and still increasing in the past two decades [2]. Epidemiologic study showed that there were over 7 million stroke survivors in China and approximately 70% of them were suffering from functional disabilities [4]. As the leading cause of disability, stroke has greatly influenced the patients’ quality of life and has left a huge burden and significant workload for their families and the whole world

[5 6]. This reality becomes a powerful impetus to search for

effective modalities of treatment for stroke rehabilitation.

Description of the intervention

Tai Chi (also known as Tai Ji or Tai Chi Chuan) is a form of physical activity that has been widely practiced in China and throughout the world. Tai Chi originated in China as a martial art hundreds of years ago. Based on mind-body connection, combined of physical movement, meditation and breathing control, Tai Chi induces relaxation and tranquility of the mind and improves balance, postural control, movement coordination, strength, and flexibility [7-9]. Tai Chi has become a popular exercise worldwide in recent years [10]. Numerous studies have been conducted on the clinical application of Tai Chi and have validated its effects in improving symptoms of different conditions [10]. Previous studies indicated that Tai Chi can be prescribed as a beneficial and safe exercise for neurological disease [11 12], cardiovascular disease [13 14], orthopaedic disease

[9 15], rheumatological disease

[16], cancer

[17], and some other certain

conditions. Tai Chi has also been incorporated into stroke rehabilitation programs

[18 19]. Previous

studies and reviews suggested that Tai Chi is safe and feasible for stroke patients with functional disabilities and may serve as an additional exercise modality of stroke rehabilitation. It has been demonstrated that Tai Chi is beneficial in improving motor function [20], standing balance[21 22], quality of life [20 21], and reducing fall rates [20] in stroke patients. What’s more, there are also some ongoing studies trying to further investigate the effects of Tai Chi for stroke rehabilitation [23 24]. Thus, it is necessary to systematically review the efficacy and safety of Tai Chi for stroke rehabilitation and provide further clinical evidence for both clinicians’ and patients’ benefits.

How the intervention might work

The reason why Tai Chi is helpful for stroke patients is that the main essence of Tai Chi practicing is similar with the mechanisms of conventional stroke rehabilitation techniques, like the Bobath program and the Proprioceptive Neuromuscular Facilitation

[18]. Most Tai Chi

movements are helical and aimed at strengthening the limbs and core muscles of the abdomen and back

[25]. This corresponds with conventional stroke rehabilitation techniques which also

focus on strength exercises for the limbs and the trunk. Since Tai Chi is practiced mostly on one foot, it is also a weight-bearing exercise that improves balance similar to conventional rehabilitation [19]. The requirement of deep breathing and relaxation of the body and mind when practicing Tai Chi is consistent with stroke rehabilitation therapies that encourage patients to relax and stay calm to achieve a better recovery. One of the most important principles of Tai Chi is “conquering the unyielding with the yielding,” which corresponds with physiotherapy in treating spasticity with gentle manipulation.

OBJECTIVES

Page 3 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



The objective of this review is to systematically evaluate the efficacy and safety of Tai Chi for the rehabilitation in stroke patients.

METHODS AND ANALYSIS

Types of studies

We will only include clinical randomised controlled trials (RCTs) in English and Chinese without any restrictions on publication status. Non-RCTs, quasi-RCTs and uncontrolled clinical trials such as case studies will be excluded.

Types of participants

Trials involving patients of any age with ischemic or haemorrhagic stroke will be included. Stroke must be diagnosed according to the World Health Organization definition (Rapidly developed clinical signs of focal or global disturbances of cerebral function, lasting more than 24 hours or leading to death, with no other apparent cause than of vascular origin) [26] or confirmed with confirmed by computerised tomography (CT) or magnetic resonance imaging (MRI). There will be no limitation in relation to time from the onset of stroke. Patients with subarachnoid haemorrhage or subdural hematoma will be excluded.

Types of interventions

Same to that of other mind-body interventions like Yoga and Qigong, Tai Chi is also inherently varied and heterogeneous which made it difficult to be standardized. Thus, we will accept all types of Tai Chi interventions regardless of their forms, styles, durations, and frequencies. However, stratified analysis according to the aforementioned factors of Tai Chi will be performed if sufficient studies included. The intervention in the treatment group should be Tai Chi exercises with or without conventional rehabilitative treatment. The control intervention will include conventional rehabilitative treatment, other forms of exercises, or no treatment. Some other co-interventions, such as basic medications for stroke, life style modifications for stroke, stroke diets, stroke education programs, are acceptable on condition that same co-interventions are simultaneously applied in all arms of a study.

Types of outcome assessments

Primary outcomes

The primary outcomes of this review will focus on patients’ changes of neurological functions and independence in activities of daily living. This will encompass assessment tools based on the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment (FMA), modified Rankin Scale (mRS), Barthel Index (BI), Berg Balance Scale (BBS), Stroke-Specific Quality of Life Scale (SSQOL), or the researchers’ own definition.

Secondary outcomes

Secondary outcome measures will include possible adverse events associated with Tai Chi practising, all-cause death during the whole treatment and follow-up period, the adherence to Tai Chi, and costs and cost effectiveness of Tai Chi.

Search methods for identification of studies

Electronic searches

We will conduct a systematic search of the following electronic databases from inception to October 31, 2015: MEDLINE, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), and China’s Dissertation Database (CDD). We have developed the MEDLINE search strategy (see table 1) based on the guidance of the Cochrane handbook and will apply similar strategy for other electronic databases.

Page 4 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Other resources

The WHO International Clinical Trials Registry Platform (ICTRP) and its Registry Network and the reference lists of related reviews and retrieved articles will be checked for additional studies. We will also scan the abstracts of non-English language studies if they are available in English. We will also search relevant conference papers in this area.

Data collection and analysis

Selection of studies

Two review authors (YZ and SW) will independently check the titles and abstracts of retrieved results and select all potentially relevant references. All records will be managed by Endnote X7 in a separate database. The two reviewers will then independently read the full texts to choose studies to be included based on our predetermined inclusion criteria. In case of unclear information or missing data, we will contact the original authors for clarification. Disagreements of inclusion will be resolved by discussion and judged by an experienced reviewer (XZ). Details of the entire selection procedure will be shown in a PRISMA flow chart (see figure 1).

Data extraction and management

Two review authors (YZ and SW) will independently carry out the data extraction using a piloted data extraction form which will be developed by all authors referring to previous published systematic review papers on Tai Chi and stroke. Data will include general information of the publications (reference identification, authors, country, journal name, year of publication, et al) , details of study design (sample size, randomisation, blinding, et al), participants (inclusion and exclusion criteria, age, gender, disease duration, et al), interventions (types of Tai Chi, types of control, duration, frequency, et al), outcomes (observation time points, measurement tools, follow-up, adherence, adverse events, costs and cost effectiveness, et al). The original authors will be contacted in case of missing data. Where there is a disagreement of data extraction, a third experienced reviewer (XZ) will be consulted for consensus.

Assessment of risk of bias in included studies

Risk of bias will be assessed by two independent authors (YZ and SW) using the Cochrane risk of bias tool recommended by the Cochrane Reviewer’s Handbook. Any disagreements will be resolved through consultation with a third experienced reviewer (XZ). The following items will be assessed for risk of bias: selection bias, performance bias, detection bias, attrition bias, reporting bias, and other sources of bias. We will not report bias of participants and personnel blinding because of the involvement of Tai Chi which will make it impossible to blind them. All included studies will be categorized into three categories which are high, unclear, and low risk of bias.

Measure of treatment effect

We will calculate risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MDs) or standard mean differences (SMDs) with 95% CIs for continuous outcomes.

Unit of analysis issues

The primary unit of analysis will be all individuals participated in the trials. In case of three or more different intervention groups within a trial, we will present pairwise comparison results through different subgroups of interventions. If available, we will combine relevant groups to make a single pairwise comparison with the Tai Chi group.

Dealing with missing data

Page 5 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



We will contact the original authors in case of missing data. If this fails to elicit required information, we will only analyse the available data and address the potential impact of these missing data to the results of the review in the part of discussion.

Assessment of heterogeneity

We will check the results of the chi-squared test (significance level: 0.1) to assess the heterogeneity of included studies and the I

2 statistic to assess quantify inconsistency. An I

2 value

of 50% or higher will indicate the presence of substantial heterogeneity. If there is a low level of heterogeneity among included studies, we will synthesize the results in a meta-analysis. In case of substantial heterogeneity, we will perform a systematic synthesis instead.

Assessment of reporting biases

We will assess reporting bias according to the CONSORT criteria and will generate the funnel plots to assess reporting bias if sufficient studies included. We will try to explore possible interpretations other than publication bias and language bias if asymmetric funnel plots appears.

Data synthesis

Data synthesis will be performed with the Cochrane Review Manager software (version 5.3). We will adopt the fixed effects model or random effects model depending on the results of heterogeneity assessment.

Subgroup analysis

We plan to carry out subgroup analysis if sufficient comparable studies identified. We intend to stratify the results by duration, style, frequency of Tai Chi. We will also focus on subgroup analyses of comparison between Tai Chi and different stroke rehabilitation treatments. The incidence rate of different types of adverse events will also be calculated.

Sensitivity analysis

To ensure the robustness of evidence, we will perform sensitivity analysis to assess the impact of studies with high risk of bias. We will compare the results to decide whether studies with lower quality should be excluded on the basis of sample size, strength of evidence and influence on pooled effective size.

Grading the quality of evidence

To help health professional make a judgment on individual patients, we will further evaluate the quality of evidence for outcomes by using the GRADE system. We will also consider the quality of evidence, potential benefits and harms, study context and patients’ value when interpreting the results.

Ethics and dissemination

This systematic review does not require formal ethical approval because all data used will be anonymous with no concerns regarding privacy. Results will provide a general overview and evidence of the effectiveness and safety of Tai Chi for stroke rehabilitation. Findings will be disseminated through peer-reviewed publications.

DISCUSSION The previous review which was published 3 years ago failed to determine the beneficial effects of Tai Chi for stroke rehabilitation

[27]. Another Cochrane review aimed at evaluating the

effectiveness of Tai Chi on dependency and motor function for the recovery of stroke patients was registered in December 2012 [28]. However, they failed to provide any results of their review.

Page 6 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Nearly 10 new RCTs applying Tai Chi for stoke rehabilitation have been published within the past 3 years. Thus, it is necessary to launch a systematic review to reassess the efficacy and safety of Tai Chi for stroke rehabilitation. In the current paper, we described the protocol of a systematic review designed to assess the efficacy and safety of Tai Chi for stroke rehabilitation. We hope that our results may translate the contributions of clinical research into patients’ benefits and provide further clinical evidence for both clinicians and patients to make decisions in practising Tai Chi for stroke rehabilitation.

However, the current systematic review has some potential limitations. A language bias may exist as we will only include studies published in English and Chinese which will lead to some relevant studies in other languages missed (eg. Korean and Japanese). Another limitation is that significant heterogeneity may appear due to the various types of Tai Chi forms, styles, durations, and frequencies.

Contributors

YZ, XZ and ZL conceived the study. The protocol was drafted by YZ, and revised by XZ and ZL. YZ, SW, PC and XZ developed the search strategy. YZ and SW will independently work on data extraction and synthesis.

Funding

This work is supported by the following funding: the Middle-aged Teachers Research Funds of Beijing University of Chinese Medicine (Grant no. 2015-JYB-JSMS082); the Australia-China Council Funding 2015-2016 for Australia-China Chinese Medicine Education Program hosted by Western Sydney University and Beijing University of Chinese Medicine; the Oversea Teachers Program of China Confucius Institute Headquarters (Hanban).

Competing interests

None.

Provenance and peer review

Data sharing statement

Results of the current review will be disseminated through peer-reviewed publications.

REFERENCES 1. Johnston SC, Mendis S, Mathers CD. Global variation in stroke burden and mortality: estimates from

monitoring, surveillance, and modelling. Lancet Neurology 2009;8(4):345-54.

2. Feigin VL, Forouzanfar MH, Krishnamurthi R, et al. Global and regional burden of stroke during 1990-

2010: findings from the Global Burden of Disease Study 2010. Lancet 2014;383(9913):245-54.

3. Giroud M, Jacquin A, Bejot Y. The worldwide landscape of stroke in the 21st century. Lancet

2014;383(9913):195-97.

4. Liu M, Wu B, Wang WZ, et al. Stroke in China: epidemiology, prevention, and management strategies.

Lancet Neurology 2007;6(5):456-64.

5. Liu L, Wang D, Wong KS, et al. Stroke and stroke care in China: huge burden, significant workload, and

a national priority. Stroke 2011;42(12):3651-54.

6. Zhang Y, Jin H, Ma D, et al. Efficacy of Integrated Rehabilitation Techniques of Traditional Chinese

Medicine for ischemic stroke: a randomized controlled trial. American Journal of Chinese

Medicine 2013;41(5):971-81.

7. Yang GY, Wang LQ, Ren J, et al. Evidence base of clinical studies on Tai Chi: a bibliometric analysis.

PLoS One 2015;10(3):e0120655.

Page 7 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



8. Zhang L, Layne C, Lowder T, et al. A review focused on the psychological effectiveness of tai chi on

different populations. Evidence-based Complementary and Alternative Medicine

2012;2012(2012):e678107.

9. Wang C, Schmid CH, Rones R, et al. A randomized trial of tai chi for fibromyalgia. New England Journal

of Medicine 2010;363(8):743-54.

10. Lan C, Chen S-Y, Lai J-S, et al. Tai Chi chuan in medicine and health promotion. Evidence-Based

Complementary and Alternative Medicine 2013;2013(2013):e502131.

11. Yang Y, Li XY, Gong L, et al. Tai Chi for improvement of motor function, balance and gait in

Parkinson's disease: a systematic review and meta-analysis. PLoS One 2014;9(7):e102942.

12. Li F, Harmer P, Fitzgerald K, et al. Tai chi and postural stability in patients with Parkinson's disease.

New England Journal of Medicine 2012;366(6):511-19.

13. Lee MS, Pittler MH, Taylor-Piliae RE, et al. Tai chi for cardiovascular disease and its risk factors: a

systematic review. Journal of Hypertension 2007;25(9):1974-75.

14. Lan C, Chen SY, Wong MK, et al. Tai chi chuan exercise for patients with cardiovascular disease.

Evidence-Based Complementary and Alternative medicine 2013;2013(2013):e983208.

15. Song QH, Zhang QH, Xu RM, et al. Effect of Tai-chi exercise on lower limb muscle strength, bone

mineral density and balance function of elderly women. International Journal of Clinical and

Experimental Medicine 2014;7(6):1569-76.

16. Lee MS, Pittler MH, Ernst E. Tai chi for rheumatoid arthritis: systematic review. Rheumatology

(Oxford) 2007;46(11):1648-51.

17. Pan Y, Yang K, Shi X, et al. Tai chi chuan exercise for patients with breast cancer: a systematic review

and meta-analysis. Evidence-Based Complementary and Alternative Medicine

2015;2015(2015):e535237.

18. Yu MH, Wang WD. Tai Chi Exercise and hemiplegia rehabilitation. Chinese Journal of Rehabiliation

Theory and Practice 2002;18(7):447-48.

19. Taylor-Piliae RE, Haskell WL. Tai Chi exercise and stroke rehabilitation. Topic in Stroke Rehabilitation

2007;14(4):9-22.

20. Taylor-Piliae RE, Hoke TM, Hepworth JT, et al. Effect of Tai Chi on physical function, fall rates and

quality of life among older stroke survivors. Archives of Physical Medicine and Rehabilitation

2014;95(5):816-24.

21. Kim H, Kim YL, Lee SM. Effects of therapeutic Tai Chi on balance, gait, and quality of life in chronic

stroke patients. International Journal of Rehabilitation Research 2015;38(2):156-61.

22. Au-Yeung SS, Hui-Chan CW, Tang JC. Short-form Tai Chi improves standing balance of people with

chronic stroke. Neurorehabilitation and Neural Repair 2009;23(5):515-22.

23. Tao J, Rao T, Lin L, et al. Evaluation of Tai Chi Yunshou exercises on community-based stroke patients

with balance dysfunction: a study protocol of a cluster randomized controlled trial. BMC

Complementary and Alternative Medicine 2015;15(1):31.

24. Zhang Y, Liu H, Zhou L, et al. Applying Tai Chi as a rehabilitation program for stroke patients in the

recovery phase: study protocol for a randomized controlled trial. Trials 2014;15(1):484.

25. Lan C, Lai JS, Chen SY, et al. Tai Chi Chuan to improve muscular strength and endurance in elderly

individuals: a pilot study. Archives of Physical Medicine and Rehabilitation 2000;81(5):604-07.

26. WHO. Stroke-1989. Recommendations on stroke prevention, diagnosis, and therapy. Report of the

WHO task force on stroke and other cerebrovascular disorders. Stroke 1989;20(10):1407-31.

27. Ding M. Tai Chi for stroke rehabilitation: a focused review. American Journal of Physical Medicine &

Rehabilitation 2012;91(12):1091-96.

28. Xu C, Zhang HW, Leung AW, et al. Tai Chi for improving recovery after stroke (protocol). Cochrane

Database of Systematic Reviews 2012;2012(12):CD010207.

Page 8 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Table 1: Search strategy for MEDLINE.

Number Search items

1 exp tai chi/ or tai ji/

2 (tai chi or tai ji or taichi or tai chi chuan or taichi chuan or taiji or tai ji quan or taiji quan or martial arts or shadowbox$ ) .tw.

3 or/ 1-2

4

cerebrovascular disorders/ or exp basal ganglia cerebrovascular disease/ or exp brain ischemia/ or exp carotid artery diseases/ or exp intracranial arterial diseases/ or exp “intracranial embolism and thrombosis”/ or exp intracranial hemorrhages/ or stroke/ or exp brain infarction/ or vasospasm, intracranial/ or vertebral artery dissection/

5 (stroke or poststroke or post-stroke or cerebrovasc$ or brain vasc$ or cerebral vasc$ or cva$ or apoplex$).tw.

6 ((brain$ or cerebr$ or cerebell$ or intracran$ or intracerebral) adj5 (isch?emi$ or infarct$ or thrombo$ or emboli$ or occlus$)).tw.

7 ((brain$ or cerebr$ or cerebell$ or intracerebral or intracranial or subarachnoid) adj5 (haemorrhage$ or hemorrhage$ or haematoma$ or hematoma$ or bleed$)).tw.

8 hemiplegia/ or exp paresis/

9 (hemipleg$ or hemipar$ or paresis or paretic).tw.

10 or/ 4-9

11 3 and 10

Page 9 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Records identified through database searching

from their conception to to October 31, 2015.

Medline (n=); Embase (n=); Cochrane (n=);

CMB (n=); CNKI (n=); VIP (n=); CDD (n=).

Records after duplicates removed (n=)

Records screened (n=)

Full-text articles assessed for

eligibility (n=)

Records excluded

Not related to Tai Chi (n=)

Not related to stroke (n=)

Not related to human (n=)

Not RCT (n=)

Studies included in qualitative

synthesis (n=)

Full-text article excluded

and reasons (n=)

Studies included in quantitative synthesis

(meta-analysis) (n=)

Iden

tifica

tion

Scr

eenin

g

Eligib

ility

Inclu

ded

Additional records

from other sources

(n=)

Figure 1: Flow diagram of the study selection process.

Page 10 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from




review

Journal: BMJ Open

Manuscript ID bmjopen-2015-010866.R1


Date Submitted by the Author: 31-Mar-2016

Complete List of Authors: Zhang, Yong; Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine, Department of Rehabilitation; National Institute of Complementary Medicine, Western Sydney University Wang, Shanshan; Beijing University of Chinese Medicine, Department of International Communications; National Institute of Complementary Medicine, Western Sydney University Chen, Pei; Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine, Department of Neurology and Stroke

Center Zhu, Xiaoshu; National Institute of Complementary Medicine, Western Sydney University Li, Zongheng; Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine, Department of Rehabilitation








jopen.bmj.com

/B

MJ O


ownloaded from




Yong Zhang, 1,2,3,4 Shanshan Wang, 2,4 Pei Chen,3 Xiaoshu Zhu, 2 Zongheng Li1 1 Department of Rehabilitation, Dongzhimen Hospital, the First Affiliated Hospital of Beijing




100029, China Correspondence to: Dr. Zongheng Li, [email protected]

Page 1 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Abstract:


Methods and analysis: We will conduct a systematic search of the following electronic databases from their inception to October 31, 2015: MEDLINE, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang, and China’s Dissertation Database. All relevant randomised controlled trials (RCTs) in English and Chinese will be included. The main outcomes will be patients’ changes of neurological functions and independence in activities of daily living. Adverse events, adherence, costs and cost effectiveness of Tai Chi will also be assessed. Two independent reviewers will work on study selection, data extraction and quality assessment. The Review manage 5.3 will be used for assessment of risk of bias, data synthesis and subgroup analysis.







Page 2 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



INTRODUCTION








[16], cancer



[18 19]. Previous




[18]. Most Tai Chi




OBJECTIVES

Page 3 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from





Types of studies







Primary outcomes

The primary outcomes of this review will focus on patients’ changes of neurological functions, balance capacity and independence in activities of daily living. This will encompass assessment tools based on the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment (FMA), Berg Balance Scale (BBS), modified Rankin Scale (mRS), Barthel Index (BI), Stroke-Specific Quality of Life Scale (SSQOL), or the researchers’ own definition.

Secondary outcomes

Secondary outcome measures will include possible mental health improvements related to Tai Chi practising, adverse events associated with Tai Chi, all-cause death during the whole treatment and follow-up period, the adherence to Tai Chi, and costs and cost effectiveness of Tai Chi.


Electronic searches

We will conduct a systematic search of the following electronic databases from inception to October 31, 2015: MEDLINE, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang, and China’s Dissertation Database (CDD). We have developed the MEDLINE search strategy (see table 1) based on the guidance of the Cochrane handbook and will apply similar strategy for other electronic databases.

Page 4 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Other resources














Page 5 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from







2 value




Data synthesis


Subgroup analysis











Page 6 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from





Contributors


Funding

This work is supported by the following funding: the Middle-aged Teachers Research Funds of

Beijing University of Chinese Medicine (Grant no. 2015-JYB-JSMS082); The Second Round of

Special Project for Chinese Medicine Clinical Research Base of the China State Administration

of Traditional Chinese Medicine (Grant no. JDZX2015312); the Oversea Teachers Program of

China Confucius Institute Headquarters (Hanban).

Competing interests

None.









2014;383(9913):195-97.







Medicine 2013;41(5):971-81.


PLoS One 2015;10(3):e0120655.

Page 7 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from





2012;2012(2012):e678107.


of Medicine 2010;363(8):743-54.















(Oxford) 2007;46(11):1648-51.



2015;2015(2015):e535237.




2007;14(4):9-22.



2014;95(5):816-24.


















Page 8 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Figure legends:



Number Search items



3 or/ 1-2

4







10 or/ 4-9

11 3 and 10

Page 9 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Figure 1: Flow diagram of the study selection process. 84x80mm (300 x 300 DPI)

Page 10 of 10


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from




review

Journal: BMJ Open

Manuscript ID bmjopen-2015-010866.R2


Date Submitted by the Author: 07-May-2016

Complete List of Authors: Zhang, Yong; Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine, Department of Rehabilitation; National Institute of Complementary Medicine, Western Sydney University Wang, Shanshan; Beijing University of Chinese Medicine, Department of International Communications; National Institute of Complementary Medicine, Western Sydney University Chen, Pei; Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine, Department of Neurology and Stroke

Center Zhu, Xiaoshu; National Institute of Complementary Medicine, Western Sydney University Li, Zongheng; Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine, Department of Rehabilitation








jopen.bmj.com

/B

MJ O


ownloaded from




Yong Zhang, 1,2,3,4 Shanshan Wang, 2,4 Pei Chen,3 Xiaoshu Zhu, 2 Zongheng Li1 1 Department of Rehabilitation, Dongzhimen Hospital, the First Affiliated Hospital of Beijing




100029, China Correspondence to: Dr. Zongheng Li, [email protected]

Page 1 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Abstract:


Methods and analysis: We will conduct a systematic search of the following electronic databases from their inception to October 31, 2015: MEDLINE, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang, and China’s Dissertation Database. All relevant randomised controlled trials (RCTs) in English and Chinese will be included. The main outcomes will be patients’ changes of neurological functions and independence in activities of daily living. Adverse events, adherence, costs and cost effectiveness of Tai Chi will also be assessed. Two independent reviewers will work on study selection, data extraction and quality assessment. The Review manage 5.3 will be used for assessment of risk of bias, data synthesis and subgroup analysis.







Page 2 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



INTRODUCTION








[16], cancer



[18 19]. Previous




[18]. Most Tai Chi




OBJECTIVES

Page 3 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from





Types of studies







Primary outcomes

The primary outcomes of this review will focus on patients’ changes of neurological functions, balance capacity and independence in activities of daily living. This will encompass assessment tools based on the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment (FMA), Berg Balance Scale (BBS), modified Rankin Scale (mRS), Barthel Index (BI), Stroke-Specific Quality of Life Scale (SSQOL), or the researchers’ own definition.

Secondary outcomes

Secondary outcome measures will include possible mental health improvements related to Tai Chi practising, adverse events associated with Tai Chi, all-cause death during the whole treatment and follow-up period, the adherence to Tai Chi, and costs and cost effectiveness of Tai Chi.


Electronic searches

We will conduct a systematic search of the following electronic databases from inception to October 31, 2015: MEDLINE, EMBASE, Cochrane Library, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), Wanfang, and China’s Dissertation Database (CDD). We have developed the MEDLINE search strategy (see table 1) based on the guidance of the Cochrane handbook and will apply similar strategy for other electronic databases.

Page 4 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Other resources














Page 5 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from







2 value




Data synthesis


Subgroup analysis











Page 6 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from





Contributors


Funding

This work is supported by the following funding: the Middle-aged Teachers Research Funds of

Beijing University of Chinese Medicine (Grant no. 2015-JYB-JSMS082); The Second Round of

Special Project for Chinese Medicine Clinical Research Base of the China State Administration

of Traditional Chinese Medicine (Grant no. JDZX2015312); the Oversea Teachers Program of

China Confucius Institute Headquarters (Hanban).

Competing interests

None.









2014;383(9913):195-97.







Medicine 2013;41(5):971-81.


PLoS One 2015;10(3):e0120655.

Page 7 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from





2012;2012(2012):e678107.


of Medicine 2010;363(8):743-54.















(Oxford) 2007;46(11):1648-51.



2015;2015(2015):e535237.




2007;14(4):9-22.



2014;95(5):816-24.


















Page 8 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Figure legends:



Number Search items



3 or/ 1-2

4







10 or/ 4-9

11 3 and 10

Page 9 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



Figure 1: Flow diagram of the study selection process. 94x90mm (300 x 300 DPI)

Page 10 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM


jopen-2015-010866 on 16 June 2016. Dow

nloaded from



PRISMA-checklist

PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) 2015 checklist: recommended items to

address in a systematic review protocol

Section and topic Item

No

Checklist item Page/line

ADMINISTRATIVE INFORMATION

Title:

Identification 1a Identify the report as a protocol of a systematic review Page 1, Line 1

Update 1b If the protocol is for an update of a previous systematic review, identify as such NA

Registration 2 If registered, provide the name of the registry (such as PROSPERO) and registration number Page 2, Line 25

Authors:

Contact 3a Provide name, institutional affiliation, e-mail address of all protocol authors; provide physical mailing address of

corresponding author Page 1, Line 3-14

Contributions 3b Describe contributions of protocol authors and identify the guarantor of the review Page 7, Line 14-17

Amendments 4 If the protocol represents an amendment of a previously completed or published protocol, identify as such and list

changes; otherwise, state plan for documenting important protocol amendments NA

Support:

Sources 5a Indicate sources of financial or other support for the review Page 7, Line 19-24

Sponsor 5b Provide name for the review funder and/or sponsor Page 7, Line19-24

Role of sponsor

or funder

5c Describe roles of funder(s), sponsor(s), and/or institution(s), if any, in developing the protocol Page 7, Line19-27

INTRODUCTION

Rationale 6 Describe the rationale for the review in the context of what is already known Page 3, Line 1-49

Objectives 7 Provide an explicit statement of the question(s) the review will address with reference to participants, interventions,

comparators, and outcomes (PICO) Page 4, Line 1-2

METHODS

Eligibility criteria 8 Specify the study characteristics (such as PICO, study design, setting, time frame) and report characteristics (such as

years considered, language, publication status) to be used as criteria for eligibility for the review Page 4, Line 4-28

Information sources 9 Describe all intended information sources (such as electronic databases, contact with study authors, trial registers or

other grey literature sources) with planned dates of coverage

Page 4, Line 45-51

Page 5, Line 1-6

Page 11 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

on January 20, 2021 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2015-010866 on 16 June 2016. Downloaded from



Search strategy 10 Present draft of search strategy to be used for at least one electronic database, including planned limits, such that it

could be repeated Page 9, Line 1-23

Study records:

Data

management

11a Describe the mechanism(s) that will be used to manage records and data throughout the review Page 5, Line 8-16

Selection

process

11b State the process that will be used for selecting studies (such as two independent reviewers) through each phase of the

review (that is, screening, eligibility and inclusion in meta-analysis) Page 5, Line 18-28

Data collection

process

11c Describe planned method of extracting data from reports (such as piloting forms, done independently, in duplicate),

any processes for obtaining and confirming data from investigators Page 5, Line 18-28

Data items 12 List and define all variables for which data will be sought (such as PICO items, funding sources), any pre-planned data

assumptions and simplifications

Page 4, Line33-43

Page 5, Line 33-47

Outcomes and

prioritization

13 List and define all outcomes for which data will be sought, including prioritization of main and additional outcomes,

with rationale Page 4, Line 33-43

Risk of bias in

individual studies

14 Describe anticipated methods for assessing risk of bias of individual studies, including whether this will be done at the

outcome or study level, or both; state how this information will be used in data synthesis Page 5, Line 33-42

Data synthesis 15a Describe criteria under which study data will be quantitatively synthesised Page 6, Line 1-32

15b If data are appropriate for quantitative synthesis, describe planned summary measures, methods of handling data and

methods of combining data from studies, including any planned exploration of consistency (such as I2, Kendall’s τ)

Page 6, Line 1-32

15c Describe any proposed additional analyses (such as sensitivity or subgroup analyses, meta-regression) Page 6, Line 1-32

15d If quantitative synthesis is not appropriate, describe the type of summary planned Page 6, Line 1-32

Meta-bias(es) 16 Specify any planned assessment of meta-bias(es) (such as publication bias across studies, selective reporting within

studies) Page 6, Line 1-32

Confidence in

cumulative evidence

17 Describe how the strength of the body of evidence will be assessed (such as GRADE) Page 6, Line 33-38

From: Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart L, PRISMA-P Group. Preferred reporting items for systematic review and

meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015 Jan 2; 349: g7647.

Page 12 of 12


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

on January 20, 2021 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2015-010866 on 16 June 2016. Downloaded from


bmj open · the bobath program and the proprioceptive neuromuscular facilitation [18]. most tai chi...

Documents