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The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foot Mechanical Stimulation | Experimental | The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). |
|
| Footh Mechanical Stimulation | Sham Comparator | The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot Mechanical Stimulation (GONDOLA) | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go. | Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). | Change from Baseline in Timed Up and Go test at 1 month follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 minuts walking test. | 6 minuts walking test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). | Change from Baseline in gait speed at 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS). | Change from Baseline in UPDRS scores at 1 month follow up | |
| PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES) | Change from Baseline in PSP RATING SCALES scores at 1 month follow up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Stocchi, MD | IRCCS San Raffaele Pisana Rome Italy | Principal Investigator |
| Michela Goffredo, BME | IRCCS San Raffaele Pisana Rome Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Cassino | Cassino | FR | Italy | |||
| University Campus Biomedico of Rome |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26469868 | Derived | Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015. |
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| Gait Parameters | Gait Analysis will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). | Change from Baseline in Gait Parameters at 1 month follow up |
| FREEZING OF GAIT QUESTIONNAIRES | Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up. |
| THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) | Change from Baseline in PDQ-39 at 1 month follow up |
| Functional Ambulation classification (FAC) | Change from Baseline in FAC scores at 1 month follow up |
| Walking handicap Scale (WHS) | Change from Baseline in WHS scores at 1 month follow up |
| BOLD signal response to gondola treatment | BOLD signal will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). | Change from Baseline in UPDRS scores at 1 month follow up |
| Rome |
| 00128 |
| Italy |
| IRCCS San Raffaele Roma | Rome | 00163 | Italy |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D013494 | Supranuclear Palsy, Progressive |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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