Effects of Vibration, Gait, Shuffling, Parkinson Disease
Conditions
Keywords
Gait analysis, Proprioceptive focal stimulation, Parkinson
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).
Interventions
DEVICEEquistasi
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.
DEVICEInactive 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.
Sponsors
Istituto Auxologico Italiano
IRCCS National Neurological Institute C. Mondino Foundation
Ospedale S. Raffaele Arcangelo, Fatebenefratelli
University of Genova
IRCCS San Raffaele
I.R.C.C.S. Fondazione Santa Lucia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Spatio-Temporal gait variables at 20 weeks | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks | 20 weeks |
| Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks | 20 weeks |
| Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks | 20 weeks |
Countries
Italy
Outcome results
None listed