Background: Insoles were considered to be a beneficial adjunctive treatment option for gait rehabilitation, which could provide a proper basic support for walking. The purpose of this study was to evaluate the effect of customized insoles (Jiangsu Suyun Medical Equipment Co. Ltd, Jiangsu, China) on the gait of patients with hemiplegia.Methods: This randomized controlled trial was set in the rehabilitation department of a hospital. A total of 50 stroke patients were randomized into an experimental group (n=25) or a control group (n=25). Both groups received 40-min conventional gait training, which was conducted 5 times a week, for 4 weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for 4 weeks. The primary outcome measure was Tinetti Gait Scale (TGS), which was assessed three times(baseline[T0], 4 weeks from baseline[T1] and 4 weeks after completion of the intervention[T2]), and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), Lower Extremity Fugl-Meyer assessment (FMA-LE), Berg Balance Scale (BBS) and Barthel Index (BI), which was assessed twice(baseline[T0] and 4 weeks from baseline[T1]).Results: Compared to the control group, there were significant increases in the experimental group after 4 weeks(P = 0.014) and 4 weeks follow-up(P = 0.001) in the change of TGS, weight-bearing on the involved side (P = 0.012) or forefoot (P =0.028) when standing, weight-bearing on the involved side (P = 0.016) or forefoot (P = 0.043) when walking, early stance phase (P = 0.023) and mid stance phase (P = 0.013) on the involved side, FMA-LE (P = 0.029), BBS (P = 0.005) and BI (P = 0.009), but no difference in late stance phase (P = 0.472) on the involved side when walking and in the 6MWT (P = 0.069).Conclusions: Customized insoles had great efficacy in enhancing gait performance.Clinical Trial Registration: ChiCTR1900024843.Registered 30 July 2019,http://www.chictr.org.cn/edit.aspx?pid=41003&htm=4.
Background: Trunk function in stroke patients with hemiplegia is associated with respiration and core stability, and is also found to be associated with balance and postural control and daily activity of life. Liuzijue Qigong (LQG) is a traditional Chinese method of fitness based on breath pronunciation. The purpose of this study is to compare the clinical efficacy of LQG and traditional core stability training in the treatment of stroke patients with abnormal trunk posture. This protocol is written according to the SPIRT 2013 Statement. Methods: This study is a single-center randomized controlled trial in which 160 stroke patients are randomly divided into study group and control group. Patients in the study group will receive LQG combined with conventional rehabilitation therapy, while patients in the control group will receive traditional core stability training combined with conventional rehabilitation therapy. All treatments will be treated 45 minutes a day, 5 times a week for 2 weeks. Primary outcome (Trunk impairment scale) and secondary outcome (Berg balance scale, Fugl-Meyer assessment, Modified barthel index, Maximum phonation time, Dynamic and Static Balance Testing and The thickness and the Mobile degrees of diaphragm) will be conducted at baseline, 2 weeks at the end of the rehabilitation course. Discussion: The aim of this research is to compare the clinical efficacy of LQG and traditional core stability exercise in the treatment of stroke patients with abnormal trunk posture. Trial registration: Chinese Clinical Trial Registry: ChiCTR1800014864. Registrated on 10 February 2018, http://www.chictr.org.cn/edit.aspxpid=25313&htm=4. Keywords: Six character formula, Trunk postural control, Stroke, Core stability, Traditional core stability training, Liuzijue qigong (LQG)
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