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

IRCCS San Raffaele Roma

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Sham Gondola; Device: AMPS Gondola

Study type: Interventional

Funder types: Other

Identifiers

NCT03843268

RP 13/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

AMPS Gondola

Active Comparator group

Description:

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)

Treatment:

Device: Sham Gondola

Device: AMPS Gondola

Sham Gondola

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham Gondola

Device: AMPS Gondola