ChiCTR2000029371已完成Unknown
Effectiveness of the Expiratory flow acceleration technique in the reduction of bronchial exacerbations in patients with Parkinson's disease and swallowing deficiency : a preliminary study
未提供1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年12月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- nuber of respiratory infection and quality of life PDQ39s
研究概览
简要总结
To investigate the efficacy of the Expiratory Flow Acceleration (EFA) technique, applied using the device Free Aspire, to reduce the incidence of bronchopulmonary infections . Moreover, changes in respiratory function parameters, cough and encumbrance and quality of life scores
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The randomization assignment was provided to the recruiting physicians in sealed envelopes. The patients and the investigators who carried out the study data analysis were blinded to the patients' treatment assignments
入排标准
- 年龄范围
- 18 至 85（—）
- 性别
- All
入选标准
- •Parkinson's disease in stage III / IV of the Hoehn and
- •Yahr scale; aged <=80 years, presence at least one of the predictors of the risk of aspiration: dysphagia, dysphonia, abnormal reflex of swallowing, abnormal reflex of cough, cough after swallowing and change of voice after
- •swallowing ;Dysphagia outcome and severity scale ( DOSS ) score 3-4; Pooling score 5-12; Penetration and Aspiration (PA) scale 4-7;
- •With ability to collaborate with the study procedures.
排除标准
- •Unstable clinical conditions that in the opinion of the specialist may invalidate participation in the study; use of non-invasive diurnal and / or nocturnal mechanical ventilation; absence of caregiver; inability to cooperate with the procedures set out in the protocol;
- •The criteria for drop-out were: therapeutic adherence <=80%, refusal or failure to complete the daily diary, worsening of clinical conditions, withdrawal of consent.
研究组 & 干预措施
EFA
EFA and standard therapy
standard therapy
standard therapy
结局指标
主要结局
nuber of respiratory infection and quality of life PDQ39s
次要结局
- Respiratory function tests (FVC, FEV1) , Cough capacity test (PCEF)Questionnaires on quality of life (QoL) (Euro-QOL, ) ,VAS (Visual Analogue Scale) for cough and bronchial encumbrance.,(1-3-6 months)
研究者
研究点 (1)
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