背景:帕金森病(PD)患者表现出异常的步态模式,影响了他们的独立性和生活质量。在所有由PD引起的步态改变中,减少步长,节奏增加,在载荷响应和推离阶段,地面反作用力的减少是最常见的。可穿戴生物反馈技术提供了提供与特定步态事件或步态表现相关的单模态或多模态刺激的可能性。从而促进受试者对步态障碍的认识。此外,步态康复在临床和家庭环境中的便携性和适用性提高了PD管理的效率.可穿戴式振动触觉双向接口(BI)是一种生物反馈设备,旨在实时提取步态特征,并与特定的步态阶段同步在PD受试者的腰部提供定制的振动触觉刺激。这项研究的目的是测量BI对步态参数的影响,通常会受到典型的缓慢运动步态的影响,并评估其在临床实践中的可用性和安全性。
方法:在本例系列中,7名受试者(年龄:70.4±8.1岁;H&Y:2.7±0.3)使用了BI,并在10米人行道(10mWT)和两分钟步行测试(2MWT)上进行了测试,作为训练前(Pre-trn)和训练后(Post-trn)评估。步态测试在(Bf)和没有(No-Bf)生物反馈刺激激活的情况下以随机顺序进行。所有受试者进行了三个40分钟的训练课程,以在步行活动中熟悉BI。步态参数的描述性分析(即,步态速度,步长,节奏,步行距离,双重支持阶段)进行。双侧Wilcoxon符号检验用于评估Bf和No-Bf评估之间的差异(p<0.05)。
结果:训练后受试者提高了步态速度(Pre-trn_No-Bf:0.72(0.59,0.72)m/sec;Post-trn_Bf:0.95(0.69,0.98)m/sec;p=0.043)和步长(Pre-trn_No-Bf:0.87(0.81,0.96)米;在使用生物反馈期间同样,受试者的步行距离改善(Pre-trn_No-Bf:97.5(80.3,110.8)米;Post-trn_Bf:118.5(99.3,129.3)米;p=0.028),并且双支撑阶段的持续时间减少(Pre-trn_No-Bf:29.7(26.8,31.7)%;Post-trn_Bf:27.2(2MW在Pre-trn时,以节奏(Pre-trn_No-Bf:108(103.8,116.7)步/分钟;Pre-trn_Bf:101.4(96.3,111.4)步/分钟;p=0.028)检测到BI的即时效果,和步行距离在后trn(后trn_No-Bf:112.5(97.5,124.5)米;后trn_Bf:118.5(99.3,129.3)米;p=0.043)。五个受试者的SUS得分为77.5,两个受试者的SUS得分为80.3。在安全方面,所有受试者均完成方案,未发生任何不良事件.
结论:BI对于PD使用者似乎是可用和安全的。在提供详细结果的临床步行测试期间已经测量了时间步态参数。短期的BI训练表明PD患者的步态模式有所改善。这项研究为未来将BI整合为PD患者的临床评估和康复工具提供了初步支持。在医院和远程环境中。
背景:研究方案已注册(DGDMF。VI/P/I.5.I.m.2/2019/1297),并由意大利卫生部医疗器械和药学服务总局以及伦巴第大区伦理委员会批准(米兰,意大利)。
BACKGROUND: People with Parkinson\'s Disease (PD) show abnormal gait patterns compromising their independence and quality of life. Among all gait alterations due to PD, reduced step length, increased cadence, and decreased ground-reaction force during the loading response and push-off phases are the most common. Wearable biofeedback technologies offer the possibility to provide correlated single or multi-modal stimuli associated with specific gait events or gait performance, hence promoting subjects\' awareness of their gait disturbances. Moreover, the portability and applicability in clinical and home settings for gait rehabilitation increase the efficiency in the management of PD. The Wearable Vibrotactile Bidirectional Interface (BI) is a biofeedback device designed to extract gait features in real-time and deliver a customized vibrotactile stimulus at the waist of PD subjects synchronously with specific gait phases. The aims of this study were to measure the effect of the BI on gait parameters usually compromised by the typical bradykinetic gait and to assess its usability and safety in clinical practice.
METHODS: In this case series, seven subjects (age: 70.4 ± 8.1 years; H&Y: 2.7 ± 0.3) used the BI and performed a test on a 10-meter walkway (10mWT) and a two-minute walk test (2MWT) as pre-training (Pre-trn) and post-training (Post-trn) assessments. Gait tests were executed in random order with (Bf) and without (No-Bf) the activation of the biofeedback stimulus. All subjects performed three training sessions of 40 min to familiarize themselves with the BI during walking activities. A descriptive analysis of gait parameters (i.e., gait speed, step length, cadence, walking distance, double-support phase) was carried out. The 2-sided Wilcoxon sign-test was used to assess differences between Bf and No-Bf assessments (p < 0.05).
RESULTS: After training subjects improved gait speed (Pre-trn_No-Bf: 0.72(0.59,0.72) m/sec; Post-trn_Bf: 0.95(0.69,0.98) m/sec; p = 0.043) and step length (Pre-trn_No-Bf: 0.87(0.81,0.96) meters; Post-trn_Bf: 1.05(0.96,1.14) meters; p = 0.023) using the biofeedback during the 10mWT. Similarly, subjects\' walking distance improved (Pre-trn_No-Bf: 97.5 (80.3,110.8) meters; Post-trn_Bf: 118.5(99.3,129.3) meters; p = 0.028) and the duration of the double-support phase decreased (Pre-trn_No-Bf: 29.7(26.8,31.7) %; Post-trn_Bf: 27.2(24.6,28.7) %; p = 0.018) during the 2MWT. An immediate effect of the BI was detected in cadence (Pre-trn_No-Bf: 108(103.8,116.7) step/min; Pre-trn_Bf: 101.4(96.3,111.4) step/min; p = 0.028) at Pre-trn, and in walking distance at Post-trn (Post-trn_No-Bf: 112.5(97.5,124.5) meters; Post-trn_Bf: 118.5(99.3,129.3) meters; p = 0.043). SUS scores were 77.5 in five subjects and 80.3 in two subjects. In terms of safety, all subjects completed the protocol without any adverse events.
CONCLUSIONS: The BI seems to be usable and safe for PD users. Temporal gait parameters have been measured during clinical walking tests providing detailed outcomes. A short period of training with the BI suggests improvements in the gait patterns of people with PD. This research serves as preliminary support for future integration of the BI as an instrument for clinical assessment and rehabilitation in people with PD, both in hospital and remote environments.
BACKGROUND: The study protocol was registered (DGDMF.VI/P/I.5.i.m.2/2019/1297) and approved by the General Directorate of Medical Devices and Pharmaceutical Service of the Italian Ministry of Health and by the ethics committee of the Lombardy region (Milan, Italy).