Oddsson Lars I E, Bisson Teresa, Cohen Helen S, Iloputaife Ikechukwu, Jacobs Laura, Kung Doris, Lipsitz Lewis A, Manor Brad, McCracken Patricia, Rumsey Yvonne, Wrisley Diane M, Koehler-McNicholas Sara R
RxFunction Inc., Eden Prairie, MN, United States.
Department of Rehabilitation Medicine, Medical School, University of Minnesota, Minneapolis, MN, United States.
Front Aging Neurosci. 2022 Sep 20;14:931048. doi: 10.3389/fnagi.2022.931048. eCollection 2022.
We recently reported that individuals with impaired plantar sensation and high fall risk due to sensory peripheral neuropathy (PN) improved gait and balance function following 10 weeks of use of Walkasins, a wearable lower limb sensory prosthesis that provides directional specific mechanical tactile stimuli related to plantar pressure measurements during standing and walking (RxFunction Inc., Eden Prairie, MN, United States). Here, we report 26-week outcomes and compare pre- and in-study fall rates. We expected improvements in outcomes and reduced fall rates reported after 10 weeks of use to be sustained.
Participants had clinically diagnosed PN with impaired plantar sensation, high fall risk (Functional Gait Assessment, FGA score < 23) and ability to sense tactile stimuli above the ankle at the location of the device. Additional outcomes included 10 m Gait Speed, Timed Up and Go (TUG), Four-Stage Balance Test, and self-reported outcomes, including Activities-Specific Balance Confidence scale and Vestibular Disorders Activities of Daily Living Scale. Participants tracked falls using a calendar.
We assessed falls and self-reported outcomes from 44 individuals after 26 weeks of device use; 30 of them conducted in-person testing of clinical outcomes. Overall, improvements in clinical outcomes seen at 10 weeks of use remained sustained at 26 weeks with statistically significant increases compared to baseline seen in FGA scores (from 15.0 to 19.2), self-selected gait speed (from 0.89 to 0.97 m/s), and 4-Stage Balance Test (from 25.6 to 28.4 s), indicating a decrease in fall risk. Non-significant improvements were observed in TUG and fast gait speed. Overall, 39 falls were reported; 31 of them did not require medical treatment and four caused severe injury. Participants who reported falls over 6 months prior to the study had a 43% decrease in fall rate during the study as compared to self-report 6-month pre-study (11.8 vs. 6.7 falls/1000 patient days, respectively, < 0.004), similar to the 46% decrease reported after 10 weeks of use.
A wearable sensory prosthesis can improve outcomes of gait and balance function and substantially decreases incidence of falls during long-term use. The sustained long-term benefits in clinical outcomes reported here lessen the likelihood that improvements are placebo effects.
ClinicalTrials.gov, identifier #NCT03538756.
我们最近报告称，因感觉性周围神经病变（PN）导致足底感觉受损且跌倒风险高的个体，在使用Walkasins（一种可穿戴下肢感觉假体，在站立和行走过程中根据足底压力测量提供定向特定机械触觉刺激，美国明尼苏达州伊甸草原市RxFunction公司生产）10周后，步态和平衡功能得到改善。在此，我们报告26周的结果，并比较研究前和研究期间的跌倒率。我们预计使用10周后报告的结果改善和跌倒率降低将得以维持。
参与者临床诊断为PN，伴有足底感觉受损、跌倒风险高（功能性步态评估，FGA评分<23），且在装置位置处能够感知踝关节以上的触觉刺激。其他结果包括10米步态速度、计时起立行走测试（TUG）、四阶段平衡测试以及自我报告结果，包括特定活动平衡信心量表和前庭疾病日常生活活动量表。参与者使用日历记录跌倒情况。
在装置使用26周后，我们评估了44名个体的跌倒情况和自我报告结果；其中30人进行了临床结果的现场测试。总体而言，使用10周时观察到的临床结果改善在26周时仍得以维持，与基线相比，FGA评分（从15.0提高到19.2）、自我选择的步态速度（从0.89提高到0.97米/秒）和四阶段平衡测试（从25.6秒提高到28.4秒）有统计学显著增加，表明跌倒风险降低。在TUG和快速步态速度方面观察到无显著改善。总体而言，报告了39次跌倒；其中31次不需要医疗治疗，4次导致严重伤害。在研究前6个月内报告有跌倒的参与者，与研究前6个月的自我报告相比，研究期间跌倒率降低了43%（分别为11.8次与6.7次跌倒/1000患者日，<0.004），与使用10周后报告的46%的降低相似。
一种可穿戴感觉假体可以改善步态和平衡功能结果，并在长期使用期间大幅降低跌倒发生率。此处报告的临床结果中持续的长期益处降低了改善是安慰剂效应的可能性。
ClinicalTrials.gov，标识符#NCT03538756。
