Objective: The interventional clinical study GONDOPARK aims at evaluating the effects of AMPS treatment on gait speed and gait-related disorders in subjects with PD.The interventional clinical study GONDOPARK aims at evaluating the effects of AMPS treatment on gait speed and gait-related disorders in subjects with PD.

Background: 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.

Method: This multicentre, double-blind, crossover randomized controlled trial included 83 participants with PD assigned to two groups: AMPS treatment (AMPS 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.

Results: The AMPS 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.

Conclusion: This multi-centre, double-blind, crossover randomized controlled trial confirmed that automated mechanical peripheral stimulation of the soles of the feet resulted in a moderate clinical impact on gait speed in a large population of people with PD.

References: 1) Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977.

2)Stocchi F, Sale P, Kleiner AF, Casali M, Cimolin V, de Pandis F, Albertini G, Galli M. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson’s disease. Int J Rehabil Res. 2015 Sep;38(3):238-45. doi: 10.1097/MRR.0000000000000120.

3)Pagnussat AS, Kleiner AFR, Rieder CRM, Frantz A, Ehlers J, Pinto C, Dorneles G, Netto CA, Peres A, Galli M. Plantar stimulation in parkinsonians: From biomarkers to mobility – randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205. doi: 10.3233/RNN-170744.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/mechanical-peripheral-stimulation-for-the-treatment-of-gait-disorders-in-patients-with-parkinsons-disease-gondopark-a-multi-centre-double-blind-crossover-randomized-controlled-trial/