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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMPS Gondola | Active Comparator | 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) |
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| Sham Gondola | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMPS Gondola | Device | 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Stocchi, MD. PhD | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Roma | 00163 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20412722 | Background | Semprini R, Sale P, Foti C, Fini M, Franceschini M. Gait impairment in neurological disorders: a new technological approach. Funct Neurol. 2009 Oct-Dec;24(4):179-83. | |
| 11748737 | Background | Nieuwboer A, Dom R, De Weerdt W, Desloovere K, Fieuws S, Broens-Kaucsik E. Abnormalities of the spatiotemporal characteristics of gait at the onset of freezing in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1066-75. doi: 10.1002/mds.1206. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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)
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Trained professionals, not directly involved in the research treatment and blind to patients group allocation, will perform clinical assessments. All subjects will undergo inpatient rehabilitation consisting of a treatment cycles using the Gondola device, once effective (AMPS treatment) and once placebo (Sham treatment).
|
| Sham Gondola | Device | 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 |
|
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 |
| 20946640 | Result | Lo AC, Chang VC, Gianfrancesco MA, Friedman JH, Patterson TS, Benedicto DF. Reduction of freezing of gait in Parkinson's disease by repetitive robot-assisted treadmill training: a pilot study. J Neuroeng Rehabil. 2010 Oct 14;7:51. doi: 10.1186/1743-0003-7-51. |
| 40200338 | Derived | De Pandis MF, Tomino C, Proietti S, Rotondo R, Gaglione M, Casali M, Corbo M, di Biase L, Galli M, Goffredo M, Stocchi F. Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson's disease: a multi-centre, double-blind, crossover randomized controlled trial. J Neuroeng Rehabil. 2025 Apr 8;22(1):77. doi: 10.1186/s12984-025-01574-3. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |