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Randomized Controlled Trial
. 2025 Apr 8;22(1):77.
doi: 10.1186/s12984-025-01574-3.

Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson's disease: a multi-centre, double-blind, crossover randomized controlled trial

Maria Francesca De Pandis  1   2 , Carlo Tomino  3 , Stefania Proietti  3 , Rossella Rotondo  1 , Maria Gaglione  1 , Miriam Casali  3 , Massimo Corbo  4 , Lazzaro di Biase  5 , Manuela Galli  6 , Michela Goffredo #  2   3 , Fabrizio Stocchi #  7   8
Affiliations
Randomized Controlled Trial

Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson's disease: a multi-centre, double-blind, crossover randomized controlled trial

Maria Francesca De Pandis et al. J Neuroeng Rehabil. .

Abstract

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.

Methods: 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.

Results: 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.

Conclusions: AMPS stimulation improved gait speed in people with PD. Trial registration ClinicalTrials.gov identifier: NCT03843268. Date of registration: 12 Feb 2019, retrospectively registered.

Keywords: AMPS; Gait disorders; Gondola® device; Parkinson’s disease; Rehabilitation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was approved by the Ethics Committee of the Coordination Center IRCCS San Raffaele Rome on 19 April 2017 (verbale 4/2017- Registro Pareri E/10/17) and by each local institutional IRB/IEC. Signed informed consent was obtained from each patient before any study procedure. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Gondola® medical device. On the left, the effective-AMPS treatment consisted of the application of pressure via rounded stimulation tips in four specific target areas in the patient’s feet; on the right, the placebo stimulation (SHAM-AMPS treatment) was provided using the same device, protocol and therapy cycle used for effective-AMPS, but with a rigid plastic disk with a diameter of 12 mm attached to the stimulation tip
Fig. 2
Fig. 2
CONSORT flow diagram of the GondoPark study
See this image and copyright information in PMC

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