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| Name | Class |
|---|---|
| Gondola Medical Devices | UNKNOWN |
| Politecnico di Milano | OTHER |
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The purpose of this study is to evaluate safety and effectiveness of the peripheral mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF levels, immunological profile and brain functional connectivity changes in patients with Parkinson's disease.
Patients will be submitted to 8 sessions of peripheral mechanical stimulation of the feet or sham stimulation along 4 weeks.
Evaluations will be performed before and after the first session, after the forth and the eighth session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feet Mechanical Stimulation | Experimental | The feet mechanical stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA) |
|
| Sham Feet Mechanical Stimulation | Sham Comparator | The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Peripheral Stimulation (GONDOLA) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic and kinematic gait analysis | Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400). | 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of falls | Evaluated by means of the Timed Up & Go Test (TUG). | 4 weeks of treatment |
| Motor impairment | Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Ciências da Saúde de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29902470 | Derived | Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Disease and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2420-2429. doi: 10.1016/j.apmr.2018.05.009. Epub 2018 Jun 11. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 4 weeks of treatment |
| Level of depression | Evaluated by means of the Beck Depression Inventory (BDI). | 4 weeks of treatment |
| Symptoms of Parkinson's disease progress | Evaluated by means of the Hoehn and Yahr scale. | 4 weeks of treatment |
| Serum levels of BDNF | Analyzed in blood sampling. | 4 weeks of treatment |
| Sensorio-motor connectivity | Functional magnetic resonance imaging. | 4 weeks of treatment |
| Lymphocyte Proliferation Assessment | Analyzed in blood sampling. | 4 weeks of treatment |
| Cytokine and Cortisol Assessment | Analyzed in blood sampling. | 4 weeks of treatment |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |