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

This study is currently recruiting participants.
Verified August 2017 by Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia
Sponsor:
ClinicalTrials.gov Identifier:
NCT02641405
First Posted: December 29, 2015
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Istituto Auxologico Italiano
IRCCS National Neurological Institute "C. Mondino" Foundation
Ospedale S. Raffaele Arcangelo, Fatebenefratelli
University of Genova
IRCCS San Raffaele
Information provided by (Responsible Party):
Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia
  Purpose
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).

Condition Intervention
Parkinson Disease Gait, Shuffling Effects of Vibration Device: Equistasi Device: Inactive Equistasi

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study

Resource links provided by NLM:


Further study details as provided by Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia:

Primary Outcome Measures:
  • Changes in Spatio-Temporal gait variables at 20 weeks [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks [ Time Frame: 20 weeks ]
  • Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks [ Time Frame: 20 weeks ]
  • Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks [ Time Frame: 20 weeks ]

Estimated Enrollment: 126
Study Start Date: November 2015
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641405


Locations
Italy
IRCCS Santa Lucia Completed
Rome, Lazio, Italy, 00179
IRCCS National Neurological Institute "C. Mondino" Foundation Not yet recruiting
Pavia, PV, Italy
Contact: Giorgio Sandrini, MD, PROF       giorgio.sandrini@unipv.it   
Principal Investigator: Giorgio Sandrini, MD, PROF         
Sub-Investigator: Micol Avenali, MD         
Istituto Auxologico Italiano Recruiting
Oggebbio, Verbano-Cusio-Ossola, Italy, 28824
Contact: Giovanni Albani, MD       g.albani@auxologico.it   
Principal Investigator: Giovanni Albani, MD         
IRCCS San Raffaele Not yet recruiting
Cassino, Italy
Contact: Maria Francesca De Pandis, MD       maria.depandis@hsanraffaele.it   
Principal Investigator: Maria Francesca De Pandis, MD         
University of Genova Not yet recruiting
Genova, Italy
Contact: Giovanni Abbruzzese, MD,PROF       gabbar@unigev.it   
Principal Investigator: Giovanni Abruzzese, MD,PROF         
Sub-Investigator: Elisa Pelosin, MD         
Ospedale S. Raffaele Arcangelo, Fatebenefratelli Not yet recruiting
Venezia, Italy, 30121
Contact: Daniele Volpe, MD       dott.dvolpe@libero.it   
Principal Investigator: Daniele Volpe, MD         
Sponsors and Collaborators
I.R.C.C.S. Fondazione Santa Lucia
Istituto Auxologico Italiano
IRCCS National Neurological Institute "C. Mondino" Foundation
Ospedale S. Raffaele Arcangelo, Fatebenefratelli
University of Genova
IRCCS San Raffaele
  More Information

Responsible Party: Antonella Peppe, MD, PhD, I.R.C.C.S. Fondazione Santa Lucia
ClinicalTrials.gov Identifier: NCT02641405     History of Changes
Other Study ID Numbers: CE/PROG.478
First Submitted: December 3, 2015
First Posted: December 29, 2015
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia:
Gait analysis
Proprioceptive focal stimulation
Parkinson

Additional relevant MeSH terms:
Parkinson Disease
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms