Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and effectiveness of the peripheral mechanical stimulation of the feet on gait variables, clinical status, risk of falls, BDNF levels, immunological profile and brain functional connectivity changes in patients with Parkinson's disease.

Detailed Description
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Patients will be submitted to 8 sessions of peripheral mechanical stimulation of the feet or sham stimulation along 4 weeks. Evaluations will be performed before and after the first session, after the forth and the eighth session.

Official Title
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Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial

Conditions
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Parkinson's Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease based on clinical criteria, dopamine transporter (DaT) scans and/or magnetic resonance imaging; Able to walk 25 feet unassisted or with minimal assistance; Presenting freezing of gait; Aged between 50-85 years; Minimum score of 20 in the Mini Mental State Examination (MMSE); Exclusion Criteria: Secondary musculoskeletal disorder involving the lower limb, as chondral injuries, ligament and ankle sprains which may impede the realization of the gait by pain or motion disability; Peripheral neuropathy; Not attending all the treatment; Absolute contraindications for fMRI (just for fMRI examination); Presence of deep brain stimulation;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feet Mechanical Stimulation<br>The feet mechanical stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA) | Device: Mechanical Peripheral Stimulation (GONDOLA)<br> <br> * Other names: GONDOLA equipment (Ecker Technologies Sagl, Switzerland);|
| Sham Comparator: Sham Feet Mechanical Stimulation<br>The sham stimulation will be given to all participants using GONDOLA equipment (Ecker Technologies Sagl, Switzerland). Intervention: Device: Foot Mechanical Stimulation (GONDOLA) | Device: Mechanical Peripheral 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 |
| --- | --- | --- |
| Kinetic and kinematic gait analysis | Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400). | 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of falls | Evaluated by means of the Timed Up & Go Test (TUG). | 4 weeks of treatment | 
| Motor impairment | Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III). | 4 weeks of treatment | 
| Level of depression | Evaluated by means of the Beck Depression Inventory (BDI). | 4 weeks of treatment | 
| Symptoms of Parkinson's disease progress | Evaluated by means of the Hoehn and Yahr scale. | 4 weeks of treatment | 
| Serum levels of BDNF | Analyzed in blood sampling. | 4 weeks of treatment | 
| Sensorio-motor connectivity | Functional magnetic resonance imaging. | 4 weeks of treatment | 
| Lymphocyte Proliferation Assessment | Analyzed in blood sampling. | 4 weeks of treatment | 
| Cytokine and Cortisol Assessment | Analyzed in blood sampling. | 4 weeks of treatment |