Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease: a Open, Single-arm Trial

Conditions
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Freezing of Gait, Parkinson Disease

Intervention / Treatment
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* Device: EQUISTASI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Parkinson's Disease Stable drug therapy response without any change in the 3 months before the study. written informed consent Exclusion Criteria: Hoehn-Yahr stage ≥ 4 Cognitive decline (Mini Mental State Examination <26) Systemic illness involving the nervous system Diabetes Presence of cardiac pacemaker Presence of deep brain stimulation Presence of severe dysautonomia with marked hypotension History or active neoplasia Pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EQUISTASI<br>Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks. | Device: EQUISTASI<br>* Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freezing of gait questionnaire severity | Change in freezing of gait questionnaire score | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Freezing of gait, Equistasi