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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Gait, Shuffling; Effects of Vibration
• Intervention / Treatment: Device: Equistasi; Device: Inactive Equistasi

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cassino, Italy
    • IRCCS San Raffaele
  • Genova, Italy
    • University of Genova
  • Venezia, Italy, 30121
    • Ospedale S. Raffaele Arcangelo, Fatebenefratelli
  • Lazio
    • Rome, Lazio, Italy, 00179
      • IRCCS Santa Lucia
  • PV
    • Pavia, PV, Italy
      • IRCCS National Neurological Institute "C. Mondino" Foundation
  • Verbano-Cusio-Ossola
    • Oggebbio, Verbano-Cusio-Ossola, Italy, 28824
      • Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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 Comparator: Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia
• Collaborators: IRCCS San Raffaele; Istituto Auxologico Italiano; University of Genova; IRCCS National Neurological Institute "C. Mondino" Foundation; Ospedale S. Raffaele Arcangelo, Fatebenefratelli

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson; Gait analysis; Proprioceptive focal stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Gait Disorders, Neurologic
• Other Study ID Numbers: CE/PROG.478