Parkinson's Disease
Conditions
Brief summary
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
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.
Interventions
DEVICEMechanical Peripheral Stimulation (GONDOLA)
Sponsors
Gondola Medical Devices
Politecnico di Milano
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinetic and kinematic gait analysis | 4 weeks of treatment | Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of falls | 4 weeks of treatment | Evaluated by means of the Timed Up & Go Test (TUG). |
| Motor impairment | 4 weeks of treatment | Evaluated by means of the Unified Parkinson Disease Rating Scale (UPDRS III). |
| Level of depression | 4 weeks of treatment | Evaluated by means of the Beck Depression Inventory (BDI). |
| Symptoms of Parkinson's disease progress | 4 weeks of treatment | Evaluated by means of the Hoehn and Yahr scale. |
| Serum levels of BDNF | 4 weeks of treatment | Analyzed in blood sampling. |
| Sensorio-motor connectivity | 4 weeks of treatment | Functional magnetic resonance imaging. |
| Lymphocyte Proliferation Assessment | 4 weeks of treatment | Analyzed in blood sampling. |
| Cytokine and Cortisol Assessment | 4 weeks of treatment | Analyzed in blood sampling. |
Countries
Brazil
Outcome results
None listed