Effect of Customized Insoles on Gait in Post-stroke Hemiparetic Individuals: A Randomized Controlled Trial

Abstract

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.