NCT02641405

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

December 3, 2015

Last Update Submit

January 9, 2021

Conditions

Parkinson DiseaseGait, ShufflingEffects of Vibration

Keywords

Gait analysisProprioceptive focal stimulationParkinson

Outcome Measures

Primary Outcomes (1)

  • Changes in Spatio-Temporal gait variables at 20 weeks

    20 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Equistasi

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

EquistasiDEVICE

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.

Equistasi
Inactive EquistasiDEVICE

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.

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

IRCCS Santa Lucia

Rome, Lazio, 00179, Italy

Location

IRCCS National Neurological Institute "C. Mondino" Foundation

Pavia, PV, Italy

Location

Istituto Auxologico Italiano

Oggebbio, Verbano-Cusio-Ossola, 28824, Italy

Location

IRCCS San Raffaele

Cassino, Italy

Location

University of Genova

Genova, Italy

Location

Ospedale S. Raffaele Arcangelo, Fatebenefratelli

Venezia, 30121, Italy

Location

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 29, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

IT(6)