Effects of Combined Manual Therapy and Inspiratory Muscle Training on Respiratory Function, Dyspnea and Trunk Control in Neuromuscular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Posture assessment
研究概览
简要总结
The benefits of inspiratory muscle training (IMT) have been reported in neuromuscular diseases. However, its effects are limited. Further research is needed in new and complementary modalities demonstrating IMT efficacy in neuromuscular diseases. This study aimed to investigate the effect of combined IMT and manual therapy in neuromuscular diseases.
Twenty-eight children with a diagnosis of muscle disease were included in the study. Only conventional physiotherapy program was applied to the control group. In the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks. Lung function test, respiratory muscle strength, fatigue and dyspnea assessment, corbin posture analysis, sit-reach test, functional reach test (FRT), timed up and go test (TUG), motor function measure (MFM) and trunk impairment scale (TIS) were used in the evaluations.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 7 and 18 years
- •Diagnosed with a muscle disease
- •Voluntary participation
- •Cooperative and coherent
- •No hearing or visual impairment
- •Ability to ambulate independently
排除标准
- •Presence of a respiratory infection
- •Presence of a serious cardiac condition
- •History of a fracture involving the thoracic region
研究组 & 干预措施
study group
In the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks
干预措施: inspiratory muscle training (Other)
study group
In the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks
干预措施: Manual therapy (Other)
control group
Only conventional physiotherapy program was applied to the control group
干预措施: Conventional physiotherapy programme (Other)
结局指标
主要结局
Posture assessment
时间窗: Baseline and end of Week 6
Corbin posture scale was used. Lateral and posterior postural scores were summed and recorded as (0-2: excellent, 3-4: very good, 5-7: good, 8-11: fair, 12≥ poor).
Respiratory Muscle Strength
时间窗: Baseline and end of Week 6
Respiratory muscle strength was measured using Cosmed Pony FX® (US) mouth pressure measuring device. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were measured. Measurements were recorded before treatment, after the 9th treatment session, and following the 18th session
Peak flow rate (PEF)
时间窗: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Peak flow rate (PEF) (liters/second) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). PEF will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Forced expiratory volume in the first second (FEV1)
时间窗: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Forced expiratory volume in the first second (FEV1)(liters) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FEV1 will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Forced vital capacity (FVC)
时间窗: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Forced vital capacity (FVC) (liters) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FVC will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
FEV1/FVC
时间窗: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. FEV1/FVC ratio will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FEV1/FVC will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Fatigue and Dyspnea
时间窗: Baseline and end of Week 6
Fatigue and dyspnea were subjectively assessed using a visual analogue scale (VAS). Individuals were asked to rate the feeling of fatigue and dyspnea on the scale as 0: none, 10: severe.
Motor Function Measure (MFM):
时间窗: Baseline and end of Week 6
The MFM is designed to evaluate motor performance and track changes over time in individuals with neuromuscular disorders. It includes 32 items divided into three domains: standing and transfers (D1, 13 items), axial and proximal function (D2, 12 items), and distal function (D3, 7 items). Each item is rated from 0 (unable to perform) to 3 (complete performance), resulting in a maximum total score of 96. Higher scores reflect better motor abilities and lower levels of functional impairment.
次要结局
- Trunk Impairment Scale (TIS)(Baseline and end of Week 6)
- Timed Up and Go Test (TUG)(Baseline and end of Week 6)
- Sit and Reach Test:(Baseline and end of Week 6)
- Functional Reach Test (FRT)(Baseline and end of Week 6)
研究者
Hande Çağlıyan Erdoğan
phd
Istinye University