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临床试验/NCT01420796
NCT01420796已完成不适用

Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial

Federal University of Bahia1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Swallowing dynamics

研究概览

简要总结

Parkinson's disease (PD) is a chronic, degenerative disease described by motors and non-motors symptoms. Changes in swallowing and respiratory dynamics increase risk of tracheal aspiration largely responsible for increased morbidity and mortality in this population. Thus, interdisciplinary rehabilitation strategies can reduce the complications of dysphagia, with consequent improvement of the prognosis of individuals with PD. Objective: To determine the impact of combined oral motor exercises and breathing exercises on swallowing disorders in individuals with PD. Method: Clinical trial, randomized and blinded for the examinator. For all subjects will be given the stage of PD and applied quality of life questionnaire. The swallowing complaints will be investigated through structured questionnaire and functional aspects of swallowing with videofluoroscopy. The Manovacuometry Spirometry will determine measures of respiratory function. The assessment of vocal and speech disorders will be done with perceptive, acoustic, aerodynamic and electroglottographic measures as well as analysis of intelligibility. Three groups of intervention will be defined: one of them doing oral motor exercises for swallowing, one doing breathing exercises and another must do this two interventions combined. Effect of intervention will be assessed through measures of swallowing, breathing, voice and speech. The groups will be compared, according to the principle of "intention to treat" by appropriate statistical tests, according to the distribution of the dependent variables.

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Parkinson's disease diagnosed following UKPDS Criteria
  • Complaints and symptoms of dysphagia
  • Dopaminergic treatment

排除标准

  • Cranial trauma
  • Severe heart disease
  • Others neurologic disease
  • Psychiatric diseases
  • Therapy for swallowing or breathing in the last 3 months

结局指标

主要结局

Swallowing dynamics

时间窗: five weeks

Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.

次要结局

  • Vocal and speech measures(five weeks)
  • Breathing measures(five weeks)

研究者

发起方
Federal University of Bahia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalie Argolo Pereira Ponte

PhD

Federal University of Bahia

研究点 (1)

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