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Iterim analysis did not detect a clinically meaningful change in the primary endpoint
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| Name | Class |
|---|---|
| Grisons Foundation for Parkinson's Disease | OTHER |
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
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Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EQUISTASI | Experimental | Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQUISTASI | Device | Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freezing of gait questionnaire severity | Change in freezing of gait questionnaire score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gait and Falls Questionnaire (GFQ) score | Change in the GFQ score | 4 weeks |
| 39-item Parkinson's Disease Questionnaire | Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianni Pezzoli, MD | Centro Parkinson, ASST Gaetano Pini-CTO di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Parkinson, ASST Gaetano Pini-CTO | Milan | Italy |
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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 |
| Falls | Number of falls recorded during the intervention period | 4 weeks |
| Treatment continuation | Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale | 4 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |