De Pandis Maria Francesca, Tomino Carlo, Proietti Stefania, Rotondo Rossella, Gaglione Maria, Casali Miriam, Corbo Massimo, di Biase Lazzaro, Galli Manuela, Goffredo Michela, Stocchi Fabrizio
San Raffaele Hospital Cassino, Via G. Di Biasio, 1, 03043, Cassino, Italy.
Department of Human Sciences and Promotion of Quality of Life, San Raffaele Open University, Rome, Italy.
J Neuroeng Rehabil. 2025 Apr 8;22(1):77. doi: 10.1186/s12984-025-01574-3.
Pharmacological, surgical and physical therapies ameliorate motor and non-motor symptoms in Parkinson's disease (PD). Unfortunately, the progression of the disease induces deterioration in daily activities, especially in gait and balance. Invasive and non invasive medical devices have been developed to alleviate drug-resistant symptoms in patients with advanced PD, and automated mechanical peripheral stimulation (AMPS) has been proposed as a new rehabilitative approach.
This multicentre, double-blind, crossover randomized controlled trial included 83 participants with PD assigned to two groups: AMPS treatment (Gondola group, n = 40) and placebo treatment (SHAM group, n = 43). The intervention consisted of 6 sessions of stimulation over 3 weeks (AMPS or SHAM), interspersed with a wash-out period of 6 weeks, before switching groups. The aim of this study was to evaluate the effects of AMPS treatment on gait speed and gait-related disorders in subjects with PD.
The Gondola device resulted in a moderate clinical impact on gait speed in people with PD since the improvement in walking speed exceeded the cut-off of 0.14 m/s in both treatments. The improvement in walking velocity was accompanied by a significantly longer stride length and a prominent increase in % stride length without altering gait cadence in the Gondola group compared with the SHAM group.
AMPS stimulation improved gait speed in people with PD. Trial registration ClinicalTrials.gov identifier: NCT03843268. Date of registration: 12 Feb 2019, retrospectively registered.
药物、手术和物理疗法可改善帕金森病(PD)的运动和非运动症状。不幸的是,疾病的进展会导致日常活动能力下降,尤其是步态和平衡方面。已经开发出侵入性和非侵入性医疗设备来缓解晚期PD患者的耐药症状,并且自动机械外周刺激(AMPS)已被提出作为一种新的康复方法。
这项多中心、双盲、交叉随机对照试验纳入了83名PD患者,分为两组:AMPS治疗组(缆车组,n = 40)和安慰剂治疗组(假手术组,n = 43)。干预包括在3周内进行6次刺激(AMPS或假手术),两组切换前穿插6周的洗脱期。本研究的目的是评估AMPS治疗对PD患者步态速度和步态相关障碍的影响。
缆车装置对PD患者的步态速度产生了中度临床影响,因为两种治疗中步行速度的改善均超过了0.14 m/s的临界值。与假手术组相比,缆车组步行速度的改善伴随着步幅明显延长和步幅百分比显著增加,且步态节奏未改变。
AMPS刺激改善了PD患者的步态速度。试验注册ClinicalTrials.gov标识符:NCT03843268。注册日期:2019年2月12日,追溯注册。