Impact of Respiratory Training in Swallowing and Respiratory Function in Patients With Friedreich's Ataxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
This is a prospective interventional study of patients with Friedreich's Ataxia that receive respiratory strength training for a period of 12 weeks with two research visits at the beginning and at the end of the study period. Visits include swallowing evaluation with fiberoptic endoscopic evaluation of swallowing, pulmonary function testing, surface electromyography and patient surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed genetic testing of Friedreich's Ataxia
- •have an overall DIGEST score of 1 or higher based on FEES screening
- •are able to perform pulmonary function testing
排除标准
- •have been on antibiotics within 15 days prior to baseline screening.
- •have been prescribed systemic corticosteroids or neuromuscular blocking agents within 15 days of the baseline screening
- •have an allergy or contraindication to topical lidocaine or oxymetazoline
- •have any other concurrent medical condition which, in the opinion of the investigators, would make the subject inappropriate to participate in testing or respiratory exercise
结局指标
主要结局
Maximal Inspiratory Pressure (MIP)
时间窗: Through study completion (4 months)
Maximal Inspiratory Pressure (MIP) will be measured before and after the 12 week intervention
Sniff Nasal Inspiratory Pressure (SNIP)
时间窗: Through study completion (4 months)
Sniff Nasal Inspiratory Pressure (SNIP) will be measured before and after the 12 week intervention
Maximal Expiratory Pressure (MEP)
时间窗: Through study completion (4 months)
Maximal Expiratory Pressure (MEP) will be measured before and after the 12 week intervention
Diaphragm Ultrasound
时间窗: Through study completion (4 months)
Diaphragm movement will be measured through an ultrasound probe positioned on the skin before and after the 12 week intervention.
Force Vital Capacity
时间窗: Through study completion (4 months)
Forced Vital Capicity will be measured before and after the 12 week intervention
Surface Electromyography (sEMG)
时间窗: Through study completion (4 months)
sEMG will be placed on the skin to measure muscle activity involved in breathing and swallowing
Swallowing
时间窗: Through study completion (4 months)
Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention.
次要结局
未报告次要终点