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Completed

NCT Number: NCT02641405

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

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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Effects of Vibration Gait Disorders, Neurologic Gait, Shuffling Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Santa Lucia, Rome, Lazio, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Equistasi

Device

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

Device

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 outcomes

  1. Changes in Spatio-Temporal gait variables at 20 weeks

    Time frame: 20 weeks

Secondary outcomes

  1. Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks

    Time frame: 20 weeks

  2. Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks

    Time frame: 20 weeks

  3. Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Collaborators

  • IRCCS National Neurological Institute "C. Mondino" Foundation
  • IRCCS San Raffaele
  • Istituto Auxologico Italiano
  • Ospedale S. Raffaele Arcangelo, Fatebenefratelli
  • University of Genova

Registry information

Acronym: PAGE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2015
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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