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临床试验/NCT02745171
NCT02745171Unknown不适用

Continuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
change from quality of life

研究概览

简要总结

Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of degenerative and progressive, with changes in the nigrostriatal pathway, and decreased concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders of the disease. The role of physiotherapy aims to stimulate the security and independence of patients with PD in carrying out activities and to preserve and improve physical function. Some studies have shown the negative effect of the disease on quality of life and functional mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD, but many report the beneficial effects of a rehabilitation program in a short period of time.

Objective: To continually assess the effects after the completion of a physical therapy program in patients with Parkinson's disease.

Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental. Patients who are recruited will undergo an assessment using the scales of assessment of functional mobility, quality of life and motor examination before starting physical therapy at the end of treatment and two months after completion of treatment, and the intervals assessments of a month.

详细描述

The Parkinson's disease results from dysfunction of the dopaminergic systems, cholinergic, serotonergic and noradrenergic, though the neuropathological basic pattern is the change of the nigrostriatal pathway, with decreased concentration of dopamine at the level of dopamine receptors in the body striatum.

With still little known etiology in most instances, the Parkinson's disease has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. Additionally, patients may exhibit cognitive deficits and emotional changes with the progression of the disease.

The clinical diagnosis is primarily based on the identification of the cardinal motor symptoms plus the initial response to levodopa therapy . The literature is unanimous in admitting that the use of Levodopa (L-dopa) is the most effective drug for the treatment, and its administration the most recommended in satisfactory symptom control.

In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders associated disease. Although the speed of the motor of the patient learningParkinson's disease is lower than their control group of the same age, rehabilitation, these individuals may also acquire motor skills as well as improve their performance through practice repetition.

Although a physical rehabilitation program to be beneficial to improve the activities of daily living (ADL) and mobility in patients with Parkinson's disease , it is not yet clear how long its effect is sustained. Most clinical trials of physiotherapy in PD were based on short-term rehabilitation programs.

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 (Investigator)

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 diagnosed with Idiopathic Parkinson's disease according to the Bank of London Brain (Hughes et al, 1992);
  • Both sexes;
  • Patients in stages 1 through 3 for this modified version of the Hoehn & Yahr scale (HY);
  • the patient Agreement to participate in the research after explanation and understanding of it and signing the Consent and Informed.

排除标准

  • cognitive disorder identified by the Mini-Mental State Examination as schooling ;
  • Patients with other neurological diseases;
  • initiate other rehabilitative treatment throughout and after the physical therapy program.

结局指标

主要结局

change from quality of life

时间窗: change in quality of life, it is evaluated every month to complete the four-month period.

The PDQ-39 is a specific rating scale of QOL in PD and comprises 39 items that can be answered with five different response options: "never"; "On occasion"; "sometimes"; "often"; "Always" or "it is impossible for me."

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

MARIA DAS GRAÇAS WANDERLEY DE SALES CORIOLANO

Associate Professor Department of Anatomy at UFPE

Universidade Federal de Pernambuco

研究点 (2)

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