Clinical trial NCT01815281: Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy.
Official title: Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Progressive Supranuclear Palsy
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
* Able to walk 25 feet unassisted or with minimal assistance;
* On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
* Endurance sufficient to stand at least 20 minutes unassisted per patient report.

Exclusion Criteria:

* Other significant neurological or orthopedic problems.

Primary outcomes:
measure: Timed Up and Go.
timeFrame: Change from Baseline in Timed Up and Go test at 1 month follow up.
Secondary outcomes:
measure: 6 minuts walking test.
timeFrame: Change from Baseline in gait speed at 1 month follow up
measure: Gait Parameters
timeFrame: Change from Baseline in Gait Parameters at 1 month follow up
measure: FREEZING OF GAIT QUESTIONNAIRES
timeFrame: Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.
measure: THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)
timeFrame: Change from Baseline in PDQ-39 at 1 month follow up
Other outcomes:
measure: UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS).
timeFrame: Change from Baseline in UPDRS scores at 1 month follow up
measure: PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES)
timeFrame: Change from Baseline in PSP RATING SCALES scores at 1 month follow up
measure: Functional Ambulation classification (FAC)
timeFrame: Change from Baseline in FAC scores at 1 month follow up
measure: Walking handicap Scale (WHS)
timeFrame: Change from Baseline in WHS scores at 1 month follow up
measure: BOLD signal response to gondola treatment
timeFrame: Change from Baseline in UPDRS scores at 1 month follow up
Locations:
city: Cassino
country: Italy
facility: San Raffaele Cassino
state: FR
city: Rome
country: Italy
facility: University Campus Biomedico of Rome
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
Study officials:
affiliation: IRCCS San Raffaele Pisana Rome Italy
name: Fabrizio Stocchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Pisana Rome Italy
name: Michela Goffredo, BME
role: STUDY_DIRECTOR
References:
citation: Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015.