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临床试验/NCT04028817
NCT04028817Unknown不适用

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

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
10-meter walk test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

10-meter walk test

时间窗: 1 day

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daysi Tobelem

Master degree

University of Nove de Julho

研究点 (2)

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