Sublingual Photobiomodulation in Parkinson's Disease

Study Overview
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Brief Summary
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This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.

Official Title
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Evaluation of the Concentrations of Inflammatory, Protein and Oxidative Biomarkers of Parkinson's Disease After Photobiomodulation From Sublingual Laser Application - Clinical, Randomized and Blind Test

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: photobiomodulation
* Device: placebo photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons' Disease Society Brain Bank Clinical Diagnostic Criteria In the stages I to III of the disease according to Hoehn & Yahr's Parkinson's disease staging scale - modified; Individuals of both sexes, with more than 50 years who sign the informed consent form Exclusion Criteria: patients who present some adverse event during the development of the study, Who have another associated neurodegenerative disease, Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections, neoplasias, respiratory disorders, hypophysis and hypothalamus problems. Who fail to understand or perform procedures correctly because of physical and mental limitations.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group treatment<br>This group will receive laser treatment combined with low intensity exercises | Device: photobiomodulation<br>* the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied sublingual laser in a single point, with wavelength of 808 nm, diameter of 0.4 cm, with irradiance of 0.8 w / cm2, for 360 s, the laser applied will be of continuous wave with energy of 36J.<br>* Other names: low level laser therapy;|
| Placebo Comparator: group control<br>This group will receive placebo laser treatment combined with low intensity exercises | Device: placebo photobiomodulation<br>* the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied a placebo sublingual laser for 360 s.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walk test | This evaluation will be carried out from the application of the tem meter walk test. The test will be performed in a straight hall, with a line 14 meters long. The first 2 meters marked, will be provided so that the patient reaches the usual walking speed, and the last 2 meters will be provided for the patient to decelerate and stop. At the start of the test, patients will receive walking guidance at a comfortable pace. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinson's disease, Photobiomodulation, Inflammation, Oxidative stress