Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
Study NCT ID:
NCT03843268
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2019-02-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Device "Gondola" for Motor Rehabilitation in Parkinson's Disease
Sponsor:
IRCCS San Raffaele Roma
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GondoPark V2
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: