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

Parkinson Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641405
• Other study ID #: CE/PROG.478
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: January 2019

Study information

• Verified date: January 2021
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Effects of Vibration
• Gait Disorders, Neurologic
• Gait, Shuffling
• Parkinson Disease

Intervention

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.
• 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.

Locations

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

Sponsors (6)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Spatio-Temporal gait variables at 20 weeks		20 weeks
Secondary	Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks		20 weeks
Secondary	Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks		20 weeks
Secondary	Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks		20 weeks