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

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ClinicalTrials.gov Identifier: NCT02641405
Recruitment Status : Unknown
Verified August 2017 by Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia.
Recruitment status was:  Recruiting
First Posted : December 29, 2015
Last Update Posted : August 22, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE December 3, 2015
First Posted Date  ICMJE December 29, 2015
Last Update Posted Date August 22, 2017
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
Changes in Spatio-Temporal gait variables at 20 weeks [ Time Frame: 20 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
Official Title  ICMJE Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Gait, Shuffling
  • Effects of Vibration
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Equistasi
  • 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.
    Intervention: Device: Inactive Equistasi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 28, 2015)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02641405
Other Study ID Numbers  ICMJE CE/PROG.478
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia
Study Sponsor  ICMJE I.R.C.C.S. Fondazione Santa Lucia
Collaborators  ICMJE
  • Istituto Auxologico Italiano
  • IRCCS National Neurological Institute "C. Mondino" Foundation
  • Ospedale S. Raffaele Arcangelo, Fatebenefratelli
  • University of Genova
  • IRCCS San Raffaele
Investigators  ICMJE Not Provided
PRS Account I.R.C.C.S. Fondazione Santa Lucia
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP