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临床试验 NCT06840626 针对脑瘫目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial 55 随机化 儿科 运动
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临床试验NCT06840626是一项针对脑瘫的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2024年4月15日，计划招募55名患者。该研究由Semmelweis University主导，预计于2025年3月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年2月21日。
简要概括
This pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). The primary objectives of the study include assessing the effects on pulmonary functions, quality of life (QoL), depression anxiety and str...显示更多
官方标题
Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial
疾病
脑瘫其他研究标识符
- SE11568780
NCT编号
实际开始日期
2024-04-15
最近更新发布
2025-02-21
预计完成日期
2025-03-30
计划入组人数
55
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
关键词
cerebral palsy
respiratory health
spirometry
CP quality of life
respiratory health
spirometry
CP quality of life
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Intervention Arm In this group, participants received conductive education as standard rehabilitation care plus the procolized breathing exercesis. In this group, participants followed a strict protocol for breathing exercises over an 8-week period, performing them three times a day, Monday through Friday, for five minutes each session. They also adhered to prescribed ventilation guidelines, in addition to receiving standard rehabili...显示更多 | Series of breathing exercises During the intervention, participants perform respiratory exercises, including deep breathing, belly breathing, exhalation with vocalization, and forced exhalation. Each exercise is repeated five times, three times per day: twice in the morning and once in the afternoon. The exercises are conducted in a seated, corrected position, guided by rehabilitation specialists or special needs teachers who provide instructions...显示更多 |
无干预Control Arm In this group, participants received conductive education as standard rehabilitation care plus sham breathing exercises. Participants in this group followed a strict 8-week protocol for breathing exercises, which included a sham breathing protocol, performing the exercises three times a day, Monday through Friday, for one minutes each session. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Forced Expiratory Volume in 1st second (FEV1) in (L) | Change from baseline in forced expiratory volume in 1st second (FEV1)
* Description: FEV1 is the maximal volume of air that can be expired in the first second of forced vital capacity maneuver using spirometry.
* Units of Measure: L (Liter) | • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Forced Expiratory Volume in 1st second (FEV1) in % | Change from baseline in forced expiratory volume in 1st second (FEV1)
• Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards. | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Forced Vital Capacity (FVC) in (L) | * Description: FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry.
* Units of Measure: L (Liter) | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Forced Vital Capacity (FVC) in % | FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry.
• Units of Measure: Percentage (%)
The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards: | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
FEV1/FVC Ratio | Description: This is already a combined measurement (a ratio of Forced Expiratory Volume in the first second to Forced Vital Capacity).
No unit. | Measured at 0, 8, and 18 weeks. |
Peak Expiratory Flow (PEF) in (L/sec) | Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry.
Units of Measure: L/sec (Liter/secundum) | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Peak Expiratory Flow (PEF) in % | Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards. | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Cerebral Palsy Quality of Life | The CP QoL test measures changes in quality of life (QoL) across different domains, such as social and emotional well-being, acceptance, bodily pain, and functioning. The assessment is conducted at three time points: 0 weeks, 8 weeks, and 18 weeks.
Scoring and Interpretation:
Scale: Scores are recorded from 1 to 9, where 1 = Very unhappy and 9 = Very happy. Higher scores indicate better quality of life (QoL). | measurement at 0 weeks, 8 weeks, 18 weeks |
Severity and Frequency of Drooling | The severity and frequency of drooling will be assessed for changes. | measurement at 0 weeks, 8 weeks, 18 weeks |
Depression level | Depression Scale (DAS-D): Measures symptoms of depression such as low mood, hopelessness, and loss of interest.
• Scale Details:
* Minimum Score: \[0\]
* Maximum Score: \[28\]
In this scale, higher scores represent worse outcomes (indicating more severe depression symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of depression). | measurement at 0 weeks, 8 weeks, 18 weeks |
Anxiety level | Anxiety Scale (DAS-A): Assesses symptoms related to anxiety, including nervousness, panic, and fear.
Scale Details:
* Minimum Score: \[0\]
* Maximum Score: \[20\] In this scale, higher scores represent worse outcomes (indicating more severe anxiety symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of anxiety). | measurement at 0 weeks, 8 weeks, 18 weeks |
Stress level | Stress Scale (DAS-S): Evaluates stress-related symptoms like irritability, tension, and difficulty relaxing.
Scale Details:
* Minimum Score: \[0\]
* Maximum Score: \[34\] In this scale, higher scores represent worse outcomes (indicating more severe stress symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of stress). | measurement at 0 weeks, 8 weeks, 18 weeks |
Eating Ability | Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids. | measurement at 0 weeks, 8 weeks, 18 weeks |
Drinking Ability | Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids. | measurement at 0 weeks, 8 weeks, 18 weeks |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
12 Years
适龄性别
全部
- Children with cerebral palsy (GMFCS I-V)
- School-Aged 12-22 years, of both genders
- Teens and adolescents attending continuous standard care
- Capable of understanding and following commands given by the therapist
- Children who do not require respiratory support
- Children who have received recent surgical procedures or botulinum toxin injections
- Children who are unable to perform spirometry
Semmelweis UniversityCenter for Translational Medicine没有联系数据。
1 位于 1 个国家/地区的研究中心
Pest County
Semmelweis University, Conductive Pedagogical Methodology Institution and College., Budapest, Pest County, 1125, Hungary