NCT02594540
Completed
Not Applicable
Effects of the Mechanical Peripheral Stimulation for Parkinson's Disease Rehabilitation - A Randomized Clinical Trial
Federal University of Health Science of Porto Alegre1 site in 1 country28 target enrollmentDecember 2015
ConditionsParkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Federal University of Health Science of Porto Alegre
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Kinetic and kinematic gait analysis
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Aline de Souza Pagnussat
PhD
Federal University of Health Science of Porto Alegre
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Kinetic and kinematic gait analysis
Time Frame: 4 weeks of treatment
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400).
Secondary Outcomes
- Symptoms of Parkinson's disease progress(4 weeks of treatment)
- Serum levels of BDNF(4 weeks of treatment)
- Cytokine and Cortisol Assessment(4 weeks of treatment)
- Sensorio-motor connectivity(4 weeks of treatment)
- Risk of falls(4 weeks of treatment)
- Motor impairment(4 weeks of treatment)
- Level of depression(4 weeks of treatment)
- Lymphocyte Proliferation Assessment(4 weeks of treatment)
Study Sites (1)
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