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| Name | Class |
|---|---|
| Istituto Auxologico Italiano | OTHER |
| IRCCS National Neurological Institute "C. Mondino" Foundation | OTHER |
| Ospedale S. Raffaele Arcangelo, Fatebenefratelli | OTHER |
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It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. A total of 126 patients suffering from PD will be recruited in 6 italian neurological centers. The study will be a cross-over multicenter study with the randomization of the sequence. The patients will be randomly assigned to 2 groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. Finally a last recording will be taken at the end of the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific Balance Confidence Scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Equistasi | Experimental | Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs. |
|
| Placebo | Placebo Comparator | Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equistasi | Device | Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Spatio-Temporal gait variables at 20 weeks | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks | 20 weeks | |
| Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Santa Lucia | Rome | Lazio | 00179 | Italy | ||
| IRCCS National Neurological Institute "C. Mondino" Foundation |
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| University of Genova |
| OTHER |
| IRCCS San Raffaele | OTHER |
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| Inactive Equistasi | Device | Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs. |
|
| Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks | 20 weeks |
| Pavia |
| PV |
| Italy |
| Istituto Auxologico Italiano | Oggebbio | Verbano-Cusio-Ossola | 28824 | Italy |
| IRCCS San Raffaele | Cassino | Italy |
| University of Genova | Genova | Italy |
| Ospedale S. Raffaele Arcangelo, Fatebenefratelli | Venezia | 30121 | Italy |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020233 | Gait Disorders, Neurologic |
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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