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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
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 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.
IRCCS Santa Lucia
Rome, Lazio, Italy
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, PV, Italy
Istituto Auxologico Italiano
Oggebbio, Verbano-Cusio-Ossola, Italy
IRCCS San Raffaele
Cassino, Italy
University of Genova
Genova, Italy
Ospedale S. Raffaele Arcangelo, Fatebenefratelli
Venezia, Italy
Changes in Spatio-Temporal gait variables at 20 weeks
Time frame: 20 weeks
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
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