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

Not Applicable

Completed

• Conditions: Effects of Vibration; Gait, Shuffling; Parkinson Disease
• Interventions: Device: Equistasi; Device: Inactive Equistasi

• Registration Number: NCT02641405
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-29
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-09
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Equistasi	Equistasi	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.
Placebo	Inactive Equistasi	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.

Primary Outcome Measures

Name	Time	Method
Changes in Spatio-Temporal gait variables at 20 weeks	20 weeks

Secondary Outcome Measures

Name	Time	Method
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
Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks	20 weeks

Trial Locations

Locations (6)

Istituto Auxologico Italiano; 🇮🇹 Oggebbio, Verbano-Cusio-Ossola, Italy

IRCCS National Neurological Institute "C. Mondino" Foundation; 🇮🇹 Pavia, PV, Italy

IRCCS Santa Lucia; 🇮🇹 Rome, Lazio, Italy

IRCCS San Raffaele; 🇮🇹 Cassino, Italy

University of Genova; 🇮🇹 Genova, Italy

Ospedale S. Raffaele Arcangelo, Fatebenefratelli; 🇮🇹 Venezia, Italy