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

Study Overview
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Brief Summary
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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.

Official Title
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Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson's Disease

Conditions
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Idiopathic Parkinson's Disease, Progressive Supranuclear Palsy

Intervention / Treatment
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* Device: Foot Mechanical Stimulation (GONDOLA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foot Mechanical Stimulation<br>The FMS stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). | Device: Foot Mechanical Stimulation (GONDOLA)<br> <br> * Other names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland).;|
| Sham Comparator: Footh Mechanical Stimulation<br>The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). | Device: Foot Mechanical Stimulation (GONDOLA)<br> <br> * Other names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from Baseline in Timed Up and Go test at 1 month follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Change from Baseline in Gait Parameters at 1 month follow up | 
| FREEZING OF GAIT QUESTIONNAIRES |  | Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up. | 
| THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) |  | Change from Baseline in PDQ-39 at 1 month follow up |