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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2019-07-19

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.

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Detailed Description

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Conditions

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Freezing of Gait Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EQUISTASI

Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.

Group Type EXPERIMENTAL

EQUISTASI

Intervention Type DEVICE

Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.

Interventions

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EQUISTASI

Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No