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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: AMPS Gondola; Device: Sham Gondola

• Registration Number: NCT03843268
• Lead Sponsor: IRCCS San Raffaele Roma

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Gondola	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.
AMPS Gondola	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)
AMPS Gondola	Sham 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)
Sham Gondola	AMPS 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.

Primary Outcome Measures

Name	Time	Method
Difference between effective treatment phase versus placebo treatment phase in the change of gait speed from PRE-treatment cycle to POST treatment cycle	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)

Secondary Outcome Measures

Name	Time	Method
Change in clinical evaluation in MDS-UPDRS	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
Change in clinical evaluation of step speed	through study completion, an average of 16 weeks	step length measured in meters per second
Change in time in walking	through study completion, an average of 16 weeks	time needed to perform the 10 meters walking test (seconds)
Change in clinical evaluation in FOG-Q	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)

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Roma, Italy