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

Sponsor

I.R.C.C.S. Fondazione Santa Lucia (Other)

Overall Status

Completed

CT.gov ID

NCT02641405

Collaborator

Istituto Auxologico Italiano (Other), IRCCS National Neurological Institute "C. Mondino" Foundation (Other), Ospedale S. Raffaele Arcangelo, Fatebenefratelli (Other), University of Genova (Other), IRCCS San Raffaele (Other)

126

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Gait, Shuffling Effects of Vibration	Device: Equistasi Device: Inactive Equistasi	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Equistasi 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.	Device: Equistasi 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.
Placebo Comparator: Placebo 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.	Device: Inactive 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.

Arm

Intervention/Treatment

Experimental: Equistasi

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.

Device: Equistasi

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.

Placebo Comparator: Placebo

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.

Device: Inactive 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.

Outcome Measures

Primary Outcome Measures

Changes in Spatio-Temporal gait variables at 20 weeks [20 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Santa Lucia	Rome	Lazio	Italy	00179
2	IRCCS National Neurological Institute "C. Mondino" Foundation	Pavia	PV	Italy
3	Istituto Auxologico Italiano	Oggebbio	Verbano-Cusio-Ossola	Italy	28824
4	IRCCS San Raffaele	Cassino		Italy
5	University of Genova	Genova		Italy
6	Ospedale S. Raffaele Arcangelo, Fatebenefratelli	Venezia		Italy	30121