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

IRCCS San Raffaele Roma20 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Idiopathic Parkinson's Disease Progressive Supranuclear Palsy

Interventions

Foot Mechanical Stimulation (GONDOLA)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

San Raffaele Cassino

Cassino, FR, Italy

University Campus Biomedico of Rome

Rome, Italy

IRCCS San Raffaele Roma

Rome, Italy

Outcomes

Primary Outcomes

Timed Up and Go.

Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).

Time frame: Change from Baseline in Timed Up and Go test at 1 month follow up.

Secondary Outcomes

6 minuts walking test.

6 minuts walking test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).

Time frame: Change from Baseline in gait speed at 1 month follow up

Gait Parameters

Gait Analysis will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13).

Time frame: Change from Baseline in Gait Parameters at 1 month follow up

FREEZING OF GAIT QUESTIONNAIRES

Time frame: Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up.

THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39)

Time frame: Change from Baseline in PDQ-39 at 1 month follow up

Data from ClinicalTrials.gov

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