Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Timed Up and Go.
Secondary Outcome
6 minuts walking test.
Condition
Idiopathic Parkinson's Disease
Intervention
Foot Mechanical Stimulation (GONDOLA)
Study Arms / Comparison Groups
Foot Mechanical Stimulation
Description: The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
July 2013
Completion Date
April 2015
Primary Completion Date
November 2013
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.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Fabrizio Stocchi, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01815281
Organization ID
GONDOLAPILOTA
Responsible Party
Sponsor
Study Sponsor
IRCCS San Raffaele Roma
Study Sponsor
Fabrizio Stocchi, MD, Principal Investigator, IRCCS San Raffaele Pisana Rome Italy
Verification Date
March 2015