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

Not Applicable

Terminated

• Conditions: Freezing of Gait; Parkinson Disease
• Interventions: Device: EQUISTASI

• Registration Number: NCT03211260
• Lead Sponsor: ASST Gaetano Pini-CTO

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-02
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Study Start: 2017-12-11
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Freezing of gait questionnaire severity	4 weeks	Change in freezing of gait questionnaire score

Secondary Outcome Measures

Name	Time	Method
39-item Parkinson's Disease Questionnaire	4 weeks	Change in quality of life measured using the 39-item Parkinson's Disease Questionnaire
Treatment continuation	4 weeks	Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Falls	4 weeks	Number of falls recorded during the intervention period
Gait and Falls Questionnaire (GFQ) score	4 weeks	Change in the GFQ score

Trial Locations

Locations (1)

Centro Parkinson, ASST Gaetano Pini-CTO; 🇮🇹 Milano, Italy