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Randomized Controlled Trial Multicenter Study
Randomized controlled trial of early rehabilitation after intracerebral hemorrhage stroke: difference in outcomes within 6 months of stroke.
- Ning Liu, Dominique A Cadilhac, Nadine E Andrew, Lingxia Zeng, Zongfang Li, Jin Li, Yan Li, Xuewen Yu, Baibing Mi, Zhe Li, Honghai Xu, Yangjing Chen, Juan Wang, Wanxia Yao, Kuo Li, Feng Yan, and Jue Wang.
- From The Key Laboratory of Biomedical Information Engineering of Ministry of Education, and Research Centre of Rehabilitation Science and Technology, School of Life Science and Technology, Xi'an Jiaotong University, National Engineering Research Centre of Health Care and Medical Devices (N.L., J.L., Jue Wang) and Department of Public Health, College of Medicine (L.Z., B.M.), Xi'an Jiaotong University, Xi'an, Shaanxi Province, People's Republic of China; Translational Public Health Unit, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia (D.A.C., N.E.A.); Public Health, Stroke Division, Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia (D.A.C.); The Second Affiliate Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, People's Republic of China (Zongfang Li, Y.L.); The First Affiliate Hospital of Xi'an Jiaotong University. Xi'an, Shaanxi Province, People's Republic of China (X.Y., Y.C., Juan Wang, W.Y., K.L.); Shaanxi Branch of China Telecom, Xi'an, Shaanxi Province, People's Republic of China (Zhe Li); and The Third Affiliate Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, People's Republic of China (H.X., F.Y.).
- Stroke. 2014 Dec 1;45(12):3502-7.
Background And PurposeMechanisms, acute management, and outcomes for patients who experience intracerebral hemorrhage may differ from patients with ischemic stroke. Studies of very early rehabilitation have been mainly undertaken in patients with ischemic stroke, and it is unknown if benefits apply to those with intracerebral hemorrhage. We hypothesized that early rehabilitation, within 48 hours of stroke, would improve survival and functional outcomes in patients with intracerebral hemorrhage.MethodsThis was a multicenter, randomized controlled study, with blinded assessment of outcome at 3 and 6 months. Eligible patients were randomized to receive standard care or standard care plus early rehabilitation. Primary outcome includes survival. Secondary outcomes includes health-related quality of life using the 36-item Short Form Questionnaire, function measured with the modified Barthel Index, and anxiety measured with the Zung Self-Rated Anxiety Scale.ResultsTwo hundred forty-three of 326 patients were randomized (mean age, 59 years; 56% men). At 6 months, patients receiving standard care were more likely to have died (adjusted hazard ratio, 4.44; 95% confidence interval [CI], 1.24-15.87); for morbidity outcomes, a 6-point difference in the Physical Component Summary score of the 36-item Short Form Questionnaire (95% CI, 4.2-8.7), a 7-point difference for the Mental Component Summary score (95% CI, 4.5-9.5), a 13-point difference in Modified Barthel Index scores (95% CI, 6.8-18.3), and a 6-point difference in Self-Rating Anxiety Scale scores (95% CI, 4.4-8.3) was reported in favor of the intervention groups.ConclusionsFor the first time, we have shown that commencing rehabilitation within 48 hours of intracerebral hemorrhage improves survival and functional outcomes at 6 months after stroke in hospitalized patients in China.Clinical Trial Registration Urlhttp://www.chictr.org/en. Unique identifier: ChiCTR-TRC-13004039.© 2014 American Heart Association, Inc.
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