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

Study Overview
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Brief Summary
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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
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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: Improving gait, reducing bradykinesia, treating Freezing of Gait symptom; Improving UPDRS II and III scores; Improving balance. Another goal of the study is to document the safety of the Gondola device.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: AMPS Gondola
* Device: Sham Gondola


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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 subject will undergo a washout period of minimum 6 weeks, then will undergo another equivalent treatment cycle (Sham or AMPS)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMPS Gondola<br>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<br>* 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.<br>Device: Sham Gondola<br>* 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<br>|
| Placebo Comparator: Sham Gondola<br>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<br>* 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.<br>Device: Sham Gondola<br>* 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<br>|

What is the study measuring?
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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 | 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 | 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 | step length measured in meters per second | through study completion, an average of 16 weeks | 
| Change in time in walking | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated Mechanical Peripheral Stimulation (AMPS), Gait Disorders