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

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, 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

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.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram of study design

References

    1. Allan LM, Rowan EN, Firbank MJ, Thomas AJ, Parry SW, Polvikoski TM, et al. Long term incidence of dementia, predictors of mortality and pathological diagnosis in older stroke survivors. Brain. 2011;134:3716–27. doi: 10.1093/brain/awr273.
    1. Douiri A, Rudd AG, Wolfe CD. Prevalence of poststroke cognitive impairment: South London Stroke Register 1995–2010. Stroke. 2013;44:138–45. doi: 10.1161/STROKEAHA.112.670844.
    1. Qu YJZL, Zhan SY. Epidemiology of post-stroke cognitive impairment: a systematic review. Chin J Geriatr Heart Brain Vessel Dis. 2013;12:1294–301.
    1. Ovbiagele B, Goldstein LB, Higashida RT, Howard VJ, Johnston SC, Khavjou OA, et al. Forecasting the future of stroke in the United States: a policy statement from the American Heart Association and American Stroke Association. Stroke. 2013;44:2361–75. doi: 10.1161/STR.0b013e31829734f2.
    1. Park JH, Kim BJ, Bae H-J, Lee J, Lee J, Han M-K, et al. Impact of post-stroke cognitive impairment with no dementia on health-related quality of life. J Stroke. 2013;15:49–56. doi: 10.5853/jos.2013.15.1.49.
    1. Taylor GH, Broomfield NM. Cognitive assessment and rehabilitation pathway for stroke (CARPS) Top Stroke Rehabil. 2013;20:270–82. doi: 10.1310/tsr2003-270.
    1. Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2013;6:CD003260.
    1. Donovan NJ, Kendall DL, Heaton SC, Kwon S, Velozo CA, Duncan PW. Conceptualizing functional cognition in stroke. Neurorehabil Neural Repair. 2008;22:122–35. doi: 10.1177/1545968307306239.
    1. Shim H. Vascular cognitive impairment and post-stroke cognitive deficits. Curr Neurol Neurosci Rep. 2014;14:418. doi: 10.1007/s11910-013-0418-4.
    1. Dichgans M, Markus HS, Salloway S, Verkkoniemi A, Moline M, Wang Q, et al. Donepezil in patients with subcortical vascular cognitive impairment: a randomised double-blind trial in CADASIL. Lancet Neurol. 2008;7:310–8. doi: 10.1016/S1474-4422(08)70046-2.
    1. Meschia JF, McNeil RB, Barrett KM, Brott TG, Graff-Radford NR, Brown RD., Jr Mayo Acute Stroke Trial for Enhancing Recovery (MASTER) protocol. J Stroke Cerebrovasc Dis. 2010;19:299–310. doi: 10.1016/j.jstrokecerebrovasdis.2009.05.005.
    1. Sarkamo T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, et al. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain. 2008;131:866–76. doi: 10.1093/brain/awn013.
    1. Singhal AB, Benner T, Roccatagliata L, Koroshetz WJ, Schaefer PW, Lo EH, et al. A pilot study of normobaric oxygen therapy in acute ischemic stroke. Stroke. 2005;36:797–802. doi: 10.1161/01.STR.0000158914.66827.2e.
    1. Gates NJ, Sachdev P. Is cognitive training an effective treatment for preclinical and early alzheimer's disease? J Alzheimer’s Dis. 2014;42(Suppl 4):S551–9.
    1. Chung CS, Pollock A, Campbell T, Durward BR, Hagen S. Cognitive rehabilitation for executive dysfunction in adults with stroke or other adult non-progressive acquired brain damage. Cochrane Database Syst Rev. 2013;4:CD008391.
    1. Cumming TB, Marshall RS, Lazar RM. Stroke, cognitive deficits, and rehabilitation: still an incomplete picture. Int J Stroke. 2013;8:38–45. doi: 10.1111/j.1747-4949.2012.00972.x.
    1. Gillespie DC, Bowen A, Chung CS, Cockburn J, Knapp P, Pollock A. Rehabilitation for post-stroke cognitive impairment: an overview of recommendations arising from systematic reviews of current evidence. Clin Rehabil. 2015;29(2):120–8. doi: 10.1177/0269215514538982.
    1. NIH Consensus Conference Acupuncture. JAMA. 1998;280:1518–24. doi: 10.1001/jama.280.17.1518.
    1. Kim SY, Lee H, Chae Y, Park HJ, Lee H. A systematic review of cost-effectiveness analyses alongside randomised controlled trials of acupuncture. Acupunct Med. 2012;30:273–85. doi: 10.1136/acupmed-2012-010178.
    1. Liu F, Li ZM, Jiang YJ, Chen LD. A meta-analysis of acupuncture use in the treatment of cognitive impairment after stroke. J Altern Complement Med. 2014;20:535–44. doi: 10.1089/acm.2013.0364.
    1. Leung MC, Yip KK, Ho YS, Siu FK, Li WC, Garner B. Mechanisms underlying the effect of acupuncture on cognitive improvement: a systematic review of animal studies. J Neuroimmune Pharmacol. 2014;9:492–507. doi: 10.1007/s11481-014-9550-4.
    1. Xd F. The studies of clinical observation and mechanism in treating the cognitive impairment after stroke by electroacupuncture at Shenting and Baihui [dissertation] China: Fujian University of Traditional Chinese Medicine, The specialty of Clinical Chinese Medicine integrated with Western Medicine; 2013.
    1. Feng X, Yang S, Liu J, Huang J, Peng J, Lin J, et al. Electroacupuncture ameliorates cognitive impairment through inhibition of nf-kappab-mediated neuronal cell apoptosis in cerebral ischemia-reperfusion injured rats. Mol Med Rep. 2013;7:1516–22.
    1. Zhou L, Zhang YL, Cao HJ, Hu H. Treating vascular mild cognitive impairment by acupuncture: a systematic review of randomized controlled trials. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2013;33:1626–30.
    1. Yang S, Ye H, Huang J, Tao J, Jiang C, Lin Z, et al. The synergistic effect of acupuncture and computer-based cognitive training on post-stroke cognitive dysfunction: a study protocol for a randomized controlled trial of 2 x 2 factorial design. BMC Complement Altern Med. 2014;14:290. doi: 10.1186/1472-6882-14-290.
    1. Liu JFX. Clinical observation of treating cognitive impairment after stroke by electroacupuncture at Baihui and Shenting with cognitive rehabilitation training. Chin J Chin Med. 2013;28:608–10.
    1. Wang YZL, Li SR, Li ZY, Tang Q. Effect of cluster needling of scalp acupuncture combined with cognition training on cognition dysfunction after cerebral infarction. Chin J Rehabil Theor Pract. 2011;17:316–8.
    1. The Fourth Academic Seminar of the Chinese Society for Neuroscience Major diagnostic points of cerebrovascular disease. Chin J Neurol. 1996;29:379–80.
    1. Chang WH, Park YH, Ohn SH, Park CH, Lee PK, Kim YH. Neural correlates of donepezil-induced cognitive improvement in patients with right hemisphere stroke: a pilot study. Neuropsychol Rehabil. 2011;21:502–14. doi: 10.1080/09602011.2011.582708.
    1. da Costa FA, Damasceno Bezerra IF, de Araujo Silva DL, de Oliveira R, da Rocha VM. Cognitive evolution by MMSE in poststroke patients. Int J Rehabil Res. 2010;33:248–53. doi: 10.1097/MRR.0b013e3283398164.
    1. Ml R. Guidelines of Cerebrovascular Disease Prevention and Treatment in China. Beijing: People’s Medical Publishing House; 2007.
    1. Zhang T. Guidelines for Chinese stroke rehabilitation. Chin J Rehabil Theor Pract. 2012;18(4):301–18.
    1. Ld C. Out of the Misunderstanding of Stroke Patients’ Rehabilitation. Beijing: People’s Medical Publishing House; 2008.
    1. National Stroke Foundation. Clinical Guidelines for Stroke Management 2010 (CP126). Australian Government National Health and Research Council (2010). . Accessed 11 June 2015.
    1. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state” a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12:189–98. doi: 10.1016/0022-3956(75)90026-6.
    1. Katzman R, Zhang MY, Ouang Ya Q, Wang ZY, Liu WT, Yu E, et al. A chinese version of the mini-mental state examination; impact of illiteracy in a shanghai dementia survey. J Clin Epidemiol. 1988;41:971–8. doi: 10.1016/0895-4356(88)90034-0.
    1. Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatrics Soc. 2005;53:695–9. doi: 10.1111/j.1532-5415.2005.53221.x.
    1. Lu J, Li D, Li F, Zhou A, Wang F, Zuo X, et al. Montreal cognitive assessment in detecting cognitive impairment in chinese elderly individuals: a population-based study. J Geriatr Psychiatry Neurol. 2011;24:184–90. doi: 10.1177/0891988711422528.
    1. Test of Attentional Performance (TAP, Version 2.3). Psytest. . Accessed 11 June 2015.
    1. Gong YX JD, Xie GR, Deng JL, Dai ZS, Zhou QZ. echsler Memory Scale-Revised manual (Chinese version) China: Hunan Medical University; 1989. pp. 2–10.
    1. Tombaugh TN. Trail making test a and b: normative data stratified by age and education. Arch Clin Neuropsychol. 2004;19:203–14. doi: 10.1016/S0887-6177(03)00039-8.
    1. Zhao Q, Guo Q, Li F, Zhou Y, Wang B, Hong Z. The shape trail test: application of a new variant of the trail making test. PLoS One. 2013;8:e57333. doi: 10.1371/journal.pone.0057333.
    1. Zysset S, Muller K, Lohmann G, von Cramon DY. Color-word matching stroop task: separating interference and response conflict. Neuroimage. 2001;13:29–36. doi: 10.1006/nimg.2000.0665.
    1. Fu TS, Wu CY, Lin KC, Hsieh CJ, Liu JS, Wang TN, et al. Psychometric comparison of the shortened fugl-meyer assessment and the streamlined wolf motor function test in stroke rehabilitation. Clin Rehabil. 2012;26:1043–7. doi: 10.1177/0269215511431474.
    1. Duncan PW, Propst M, Nelson SG. Reliability of the fugl-meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther. 1983;63:1606–10.
    1. Bennett M, Ryall N. Using the modified barthel index to estimate survival in cancer patients in hospice: observational study. BMJ. 2000;321:1381–2. doi: 10.1136/bmj.321.7273.1381.
    1. Mahoney FI, Barthel DW. Functional evaluation: the barthel index. Md State Med J. 1965;14:61–5.
    1. Shah S, Vanclay F, Cooper B. Improving the sensitivity of the barthel index for stroke rehabilitation. J Clin Epidemiol. 1989;42:703–9. doi: 10.1016/0895-4356(89)90065-6.
    1. Wang R, Wu C, Zhao Y, Yan X, Ma X, Wu M, et al. Health related quality of life measured by sf-36: a population-based study in Shanghai. China BMC Public Health. 2008;8:292. doi: 10.1186/1471-2458-8-292.
    1. Lam CL, Tse EY, Gandek B, Fong DY. The sf-36 summary scales were valid, reliable, and equivalent in a chinese population. J Clin Epidemiol. 2005;58:815–22. doi: 10.1016/j.jclinepi.2004.12.008.
    1. Park JY, Kim YH, Chang WH, Park CH, Shin YI, Kim ST, et al. Significance of longitudinal changes in the default-mode network for cognitive recovery after stroke. Eur J Neurosci. 2014;40:2715–22. doi: 10.1111/ejn.12640.
    1. Xia W, Wang S, Sun Z, Bai F, Zhou Y, Yang Y, et al. Altered baseline brain activity in type 2 diabetes: a resting-state fmri study. Psychoneuroendocrinology. 2013;38:2493–501. doi: 10.1016/j.psyneuen.2013.05.012.
    1. Gaetz M, Bernstein DM. The current status of electrophysiologic procedures for the assessment of mild traumatic brain injury. J Head Trauma Rehabil. 2001;16:386–405. doi: 10.1097/00001199-200108000-00008.
    1. Cartwright WS. Methods for the economic evaluation of health care programmes. 2nd edition. In Drummond MF, O'Brien B, Stoddart GL, Torrance GW (eds). Oxford: Oxford University Press, 1997.
    1. Skidmore ER, Whyte EM, Holm MB, Becker JT, Butters MA, Dew MA, et al. Cognitive and affective predictors of rehabilitation participation after stroke. Arch Phys Med Rehabil. 2010;91:203–7. doi: 10.1016/j.apmr.2009.10.026.
    1. Claesson L, Linden T, Skoog I, Blomstrand C. Cognitive impairment after stroke - impact on activities of daily living and costs of care for elderly people. the goteborg 70+ stroke study. Cerebrovasc Dis. 2005;19:102–9. doi: 10.1159/000082787.
    1. Cao H, Wang Y, Chang D, Zhou L, Liu J. Acupuncture for vascular mild cognitive impairment: a systematic review of randomised controlled trials. Acupunct Med. 2013;31:368–74. doi: 10.1136/acupmed-2013-010363.
    1. Leung MC, Yip KK, Lam CT, Lam KS, Lau W, Yu WL, et al. Acupuncture improves cognitive function: a systematic review. Neural Regen Res. 2013;8:1673–84.
    1. Audoin B, Au Duong MV, Malikova I, Confort-Gouny S, Ibarrola D, Cozzone PJ, et al. Functional magnetic resonance imaging and cognition at the very early stage of ms. J Neurol Sci. 2006;245:87–91. doi: 10.1016/j.jns.2005.08.026.
    1. Kotchoubey B. Event-related potentials, cognition, and behavior: a biological approach. Neurosci Biobehav Rev. 2006;30:42–65. doi: 10.1016/j.neubiorev.2005.04.002.
    1. Wolf RC, Sambataro F, Vasic N, Wolf ND, Thomann PA, Landwehrmeyer GB, et al. Longitudinal functional magnetic resonance imaging of cognition in preclinical huntington’s disease. Exp Neurol. 2011;231:214–22. doi: 10.1016/j.expneurol.2011.06.011.
    1. Lang S, Duncan N, Northoff G. Resting-state functional magnetic resonance imaging: review of neurosurgical applications. Neurosurgery. 2014;74:453–64. doi: 10.1227/NEU.0000000000000307.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Gluud LL. Bias in clinical intervention research. Am J Epidemiol. 2006;163:493–501. doi: 10.1093/aje/kwj069.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the consort statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj