Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study

Study Overview
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Brief Summary
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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).

Official Title
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Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study

Conditions
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Parkinson Disease, Gait, Shuffling, Effects of Vibration

Intervention / Treatment
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* Device: Equistasi
* Device: Inactive Equistasi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with rigid-acinetic bilateral PD form At least 4 years of disease history H&Y between 2-3 Stable drug therapy response without any change performed in the 3 months before the study. Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy. MMSE>24/30 (Mini-Mental State Examination) Exclusion Criteria: Systemic illness Presence of cardiac pacemaker Presence of deep brain stimulation Presence of severe dysautonomia with marked hypotension Obsessive-Compulsive disorder (OCD) Major depression Dementia 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Equistasi<br>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. | Device: Equistasi<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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. | Device: Inactive Equistasi<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Spatio-Temporal gait variables at 20 weeks |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait analysis, Proprioceptive focal stimulation, Parkinson