Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease and Progressive Supranuclear Palsy. (GONDOLAPILOTA)

IRCCS San Raffaele Roma

Status: Terminated

Conditions: Idiopathic Parkinson's Disease; Progressive Supranuclear Palsy

Treatments: Device: Foot Mechanical Stimulation (GONDOLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01815281

RP 12/13

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Foot Mechanical Stimulation

Experimental group

Description:

The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

Treatment:

Device: Foot Mechanical Stimulation (GONDOLA)

Footh Mechanical Stimulation

Sham Comparator group

Description:

The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland).

Treatment:

Device: Foot Mechanical Stimulation (GONDOLA)