Clinical trial NCT02641405: Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
Official title: Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Gait, Shuffling
Effects of Vibration
Keywords: Gait analysis
Proprioceptive focal stimulation
Parkinson
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: Ospedale S. Raffaele Arcangelo, Fatebenefratelli
name: University of Genova
name: IRCCS San Raffaele
First posted: 2015-12-29
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Changes in Spatio-Temporal gait variables at 20 weeks
timeFrame: 20 weeks
Secondary outcomes:
measure: Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks
timeFrame: 20 weeks
measure: Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks
timeFrame: 20 weeks
measure: Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS Santa Lucia
state: Lazio
city: Pavia
country: Italy
facility: IRCCS National Neurological Institute "C. Mondino" Foundation
state: PV
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano
state: Verbano-Cusio-Ossola
city: Cassino
country: Italy
facility: IRCCS San Raffaele
city: Genova
country: Italy
facility: University of Genova
city: Venezia
country: Italy
facility: Ospedale S. Raffaele Arcangelo, Fatebenefratelli
Study officials:
References: