Parkinson Disease Clinical Trial
— PAGEOfficial title:
Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
NCT number | NCT02641405 |
Other study ID # | CE/PROG.478 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | January 2019 |
Verified date | January 2021 |
Source | I.R.C.C.S. Fondazione Santa Lucia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 126 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS San Raffaele | Cassino | |
Italy | University of Genova | Genova | |
Italy | Istituto Auxologico Italiano | Oggebbio | Verbano-Cusio-Ossola |
Italy | IRCCS National Neurological Institute "C. Mondino" Foundation | Pavia | PV |
Italy | IRCCS Santa Lucia | Rome | Lazio |
Italy | Ospedale S. Raffaele Arcangelo, Fatebenefratelli | Venezia |
Lead Sponsor | Collaborator |
---|---|
I.R.C.C.S. Fondazione Santa Lucia | IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS San Raffaele, Istituto Auxologico Italiano, Ospedale S. Raffaele Arcangelo, Fatebenefratelli, University of Genova |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Spatio-Temporal gait variables at 20 weeks | 20 weeks | ||
Secondary | Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks | 20 weeks | ||
Secondary | Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks | 20 weeks | ||
Secondary | Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks | 20 weeks |
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