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

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

Status: Completed

Conditions: Effects of Vibration; Gait, Shuffling; Parkinson Disease

Treatments: Device: Inactive Equistasi; Device: Equistasi

Study type: Interventional

Funder types: Other

Identifiers

NCT02641405

CE/PROG.478

Details and patient eligibility

About

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).

Enrollment: 126 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Equistasi

Experimental group

Description:

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.

Treatment:

Device: Equistasi

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Inactive Equistasi