Investigation of the Effects of Functional Inspiratory Muscle Training Applied With Tele-Rehabilitation on Respiratory and Functional Parameters and Quality of Life in Children With Duchenne Muscular Dystrophy: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Respiratory Muscle Strenght Test
研究概览
简要总结
Dushenne muscular dystrophy (DMD), which is characterized by the deficiency of dystrophin protein, prevents the muscle from maintaining its normal activity, causing progressive damage to the heart, respiratory muscles and skeletal muscles. When studies on patients with DMD are examined in the literature, very few studies are found investigating the effectiveness of pure respiratory muscle training, while no studies are found investigating the effectiveness of functional respiratory muscle training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 5-17
- •Having a diagnosis of DMD based on the presence of clinical symptoms, genetic testing or muscle biopsy results
- •Having the ability to perform respiratory function tests
- •Being able to cooperate with the physiotherapist
排除标准
- •Having severe upper extremity contracture or serious systemic disease that would prevent our evaluation
- •Having a respiratory tract infection in the last 3 months
- •Having had an injury or surgery on both upper extremities in the last 6 months
研究组 & 干预措施
İntervetion Group 1
IMT will be performed.
干预措施: Respiratory Muscle Training (Other)
İntervetion group 2
Functional IMT will be performed.
干预措施: Respiratory Muscle Training (Other)
Control Group
Routine treatment will continue.
结局指标
主要结局
Respiratory Muscle Strenght Test
时间窗: eight week
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements were used to assess respiratory muscles. MIP and MEP represent the intraoral pressures measured under closed airway conditions during maximal inspiration and expiration, respectively. In this study, these measurements were performed using an intraoral pressure measurement device (Pony FX, COSMED Inc., Rome, Italy) to determine respiratory muscle strength. During the test, for MIP measurement, participants were instructed to perform a maximal inspiration for 1-3 seconds following a maximal expiration while the airway was occluded with a valve. For MEP measurement, after a maximal inspiration, the airway was occluded and participants were asked to perform a maximal expiration for 1-3 seconds. Among the three trials conducted for each parameter, the highest value was recorded.
Respiratory Function Test
时间窗: eight week
The measurements were performed using a portable spirometer. In the spirometric assessment, forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), the FEV₁/FVC ratio, and peak expiratory flow (PEF) parameters were examined, and these values were recorded as percentages of the predicted values according to age, height, body weight, and sex.
次要结局
- Six-Minute Walk Test(eight weeks)
- Modified Medical Research Council (mMRC) Dyspnea Scale(eight weeks)
研究者
Busra Turgut
specialist physiotherapist
Izmir Katip Celebi University