IEEE Trans Neural Syst Rehabil Eng. 2024;32:2993-3005. doi: 10.1109/TNSRE.2024.3435469. Epub 2024 Aug 21.
Improving tactile sensation by vibrating insoles was recommended to prevent foot ulcers in diabetic peripheral neuropathy (DPN). Lack of an insole design for diabetics was a challenge. Clinical trials on applying vibrating insoles with noise and stochastic resonance (SR) stimulating tactile were also required. In this study, vibrating foot orthoses (VFO) with a total contact design based on orthotics were proposed to provide proper insoles for diabetes. This study aimed to determine if VFO were beneficial at enhancing tactile in DPN. VFO were developed in combination with individual's custom-made foot orthoses and stimulation signals-integrating random 0-100 Hz square wave pulse signals with pseudorandom white noise by a SR approach. Sixty patients with mild-to-severe DPN were randomized to conduct crossover experiments: using and without VFO for 60 minutes stimulation at 90% of individuals' vibration perception threshold (VPT) level. VPT values when using VFO at the 1st and 5th metatarsophalangeal joints of the left foot decreased by 9.35% ( [Formula: see text].001); 9.04% ( [Formula: see text].001), and of the right foot decreased by 7.63% ( [Formula: see text].001); 7.24% ( [Formula: see text].001), respectively. Without VFO, there was no significant difference. Subgroups of mild and moderate DPN tended to benefit greatly from utilizing VFO. VFO can improve tactile in DPN. VFO may contribute to restoring/prolonging tactile and protective sensations, also decreasing peripheral nervous system deterioration. VFO might be useful for neurorehabilitation, and help prevent foot ulcers and disabilities.
通过振动鞋垫来改善触觉被推荐用于预防糖尿病周围神经病变(DPN)中的足部溃疡。缺乏针对糖尿病患者的鞋垫设计是一个挑战。还需要进行临床试验,以应用带有噪声和随机共振(SR)刺激触觉的振动鞋垫。在这项研究中,提出了基于矫形器的总接触设计的振动足矫形器(VFO),为糖尿病患者提供合适的鞋垫。本研究旨在确定 VFO 是否有益于增强 DPN 中的触觉。VFO 与个体定制的足矫形器结合开发,并通过 SR 方法整合随机 0-100Hz 方波脉冲信号和伪随机白噪声的刺激信号。60 名轻度至重度 DPN 患者被随机分为交叉实验组:使用和不使用 VFO 进行 60 分钟刺激,刺激强度为个体振动感知阈值(VPT)水平的 90%。使用 VFO 时,左足第 1 和第 5 跖趾关节的 VPT 值分别降低了 9.35%([公式:见文本]。001);9.04%([公式:见文本]。001),右足分别降低了 7.63%([公式:见文本]。001);7.24%([公式:见文本]。001)。不使用 VFO 时,差异无统计学意义。轻度和中度 DPN 的亚组患者从使用 VFO 中获益较大。VFO 可以改善 DPN 中的触觉。VFO 可能有助于恢复/延长触觉和保护感觉,也可以减缓周围神经系统的恶化。VFO 可能对神经康复有用,并有助于预防足部溃疡和残疾。