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Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease

NCT03843268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-04-10

No results posted yet for this study

Summary

The purpose of this research study is to evaluate safety and effectiveness of the Automated Mechanical Peripheral Stimulation (AMPS) therapy given via the Gondola™ device to improving Gait and Gait Related Disorders in patients with Parkinson'disease (PD). Gondola® is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the therapy requires less than 2 minutes.

Conditions

  • Parkinson Disease

Interventions

DEVICE

AMPS Gondola

Gondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the treatment requires less than 2 minutes.

DEVICE

Sham Gondola

The Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger

Sponsors & Collaborators

  • IRCCS San Raffaele Roma

    lead OTHER

Principal Investigators

  • Fabrizio Stocchi, MD. PhD · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843268 on ClinicalTrials.gov