Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease (GondoPark V2)

April 9, 2024 updated by: IRCCS San Raffaele Roma

Multi-center, Double-blind, Cross-over Randomized Study on the Use of the Medical Device "Gondola" for Motor Rehabilitation in Patients With Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed project, through a randomized multicentric, placebo controlled double-blind crossover trial aimed at evaluating the effectiveness of AMPS Gondola therapy versus Sham Gondola therapy in PD subjects. 132 in/outpatients with PD will be recruited. Subjects will be randomized in 2 groups, one starting with AMPS treatment, the other with placebo treatment. At the end of the first cycle of 6 stimulations over a 3 weeks' time (AMPS or Sham), all subjects will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS); a follow up valuation 14 days after the end of each treatment cycle will be performed.

This project is aimed at studying and documenting the effects of the AMPS treatment given to PD patients via the Gondola device in:

  1. Improving gait, reducing bradykinesia, treating Freezing of Gait symptom;
  2. Improving UPDRS II and III scores;
  3. Improving balance. Another goal of the study is to document the safety of the Gondola device.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00163
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Patients with clinically chronic and stable PD, confirmed according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBC);
  • Age 45 and older;
  • Hoehn & Yahr (H&Y) stage equal or higher than 2 in ON state;
  • Ability to walk autonomously or with minimal assistance for a 10 meters' distance in OFF state;
  • Antiparkinsonian treatment at a stable and optimized daily dosage during the 4 weeks prior to the study.

Exclusion criteria

  • Any advanced, severe or unstable disease other than PD, which may interfere with the primary and secondary study outcome evaluations (autonomic dysfunction, diabetes, renal or hepatic failure, neoplasia, balance and gait problems of other origin).
  • Cognitive impairment with MoCA < 18
  • Any peripheral neurological or musculoskeletal conditions that may alter balance and/or gait.
  • Severe lower limb injuries in the previous 6 months.
  • History of neurosurgery or orthopedic surgery.
  • History of epilepsy.
  • Any drug treatment not intended to treat PD that may alter cognitive and/or motor performance.
  • History of depression or other psychiatric disorders.
  • Severe obesity defined as a BMI greater than 35.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
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
Placebo Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle
Time Frame: through study completion, an average of 16 weeks

Study success will be defined by an:

improvement in gait speed of no less than 0,06 m/s as follows: H0: DT treatment phase - DT Sham phase < 0.06m/s v.s. Ha: DT treatment phase - DT Sham phase ≥ 0.06m/s

Where:

DT = VPost6 - VPre VPost 6= gait speed after 6 treatment stimulations (at the end of the treatment cycle) Vpre = gait speed before the 1st treatment stimulation (at the beginning of the treatment cycle)
through study completion, an average of 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical evaluation in MDS-UPDRS
Time Frame: through study completion, an average of 16 weeks
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease (MDS-UPDRS) range from 0 - less affect - to 272 - more affect
through study completion, an average of 16 weeks
Change in clinical evaluation of step speed
Time Frame: through study completion, an average of 16 weeks
step length measured in meters per second
through study completion, an average of 16 weeks
Change in time in walking
Time Frame: through study completion, an average of 16 weeks
time needed to perform the 10 meters walking test (seconds)
through study completion, an average of 16 weeks
Change in clinical evaluation in FOG-Q
Time Frame: through study completion, an average of 16 weeks
FOG-Q is a questionnaire to assess Freezing of gait (FOG) and walking among patients with Parkinson's disase (range from 0 - less affect - to 24 -more affect)
through study completion, an average of 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Fabrizio Stocchi, MD. PhD, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 13/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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