Effects of Exercise Therapy in Addition to Vacuum Bell in Patients With Pectus Carinatum
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- patient's perception of deformity
研究概览
简要总结
Pectus excavatum (PE); It is an anterior chest wall deformity, characterized by varying degrees of depression of the sternum and costal cartilage, usually occurring at birth or in the first year of life. In the treatment of non-severe PE; vacuum bell orthosis and physiotherapy (especially exercise) is recommended as an alternative to surgery. Although there is no literature or consensus about the role of physiotherapy, it is believed that it plays an important role in preventing or correcting deformities and creating a good cosmetic appearance. Therefore, in this study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to vacuum bell therapy.
详细描述
Pectus excavatum is a relatively common congenital deformity of the chest wall with an incidence of approximately 1 in every 300 births. They find that they have difficulty keeping up with their peers when playing aerobic sports. Furthermore, these patients, already embarrassed by their deformity, will avoid situations where they have to take their shirt off in front of other children, again contributing to less participation in school and team activities. Some patients may exhibit depression by withdrawing from activities with their peers and a declining quality of schoolwork. Most pectus patients have a typical geriatric or pectus posture that includes thoracic kyphosis, forward sloping shoulders and anterior pelvic tilt. A sedentary lifestyle may aggravate this posture, and the poor posture depresses the sternum even further. For this reason, the authors recommend an aggressive pectus posture exercise and breathing program.
Based on the hypothesis that the chest wall is still bendable during adolescence and that the sternum and costal ribs can be reshaped in a normal position with the external suppressor applied on the deformity, the vacuum bell, an orthosis, has been used in the conservative treatment of PE. It is the center of attention as it is an alternative method to surgery for patients.It is thought that by strengthening muscle strength and tone with exercise training, the severity of chest wall deformities can be reduced or at least prevented from progressing. It is stated that a good cosmetic appearance can be provided by exercise training especially by creating a large muscle mass on the anterior chest wall. In the single case study conducted by Canavan and Cahalin (Canavan and Cahalin, 2000) on the effect of exercise training, after 8 weeks of exercise training, the pectus severity index changed by 60% (50 millimeter decreased from 20 millimeter), and during recreational activities and shoulder pain was not found. Therefore, the investigators aimed to investigate the effectiveness of exercise therapy in addition to vacuum bell therapy.
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
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with PE by doctor and indicated for the first time orthotic use
- •10-18 years old,
- •Discontented with this deformity
排除标准
- •Previous orthosis use
- •Severe scoliosis (Cobb angle above 20 degrees)
- •Having chronic systemic disease
- •Having serious psychiatric illness
- •Having complex mixed pectus deformity
结局指标
主要结局
patient's perception of deformity
时间窗: Change from baseline patient's perception of deformity at 12 weeks
patient's perception of deformity (0-10):The subject's self-perception of pectus excavatum was obtained through self-report using a scale from 0 (worst self-perception of pectus excavatum) to 10 (best self-perception of pectus excavatum).
Global Rating of Change Score
时间窗: Through study completion, an average of 12 weeks
The responses for the Global Rating of Change Score were "much better (2)"; "slightly better (1)"; "stayed the same (0)";"slightly worse (-1)" or "much worse (-2)"
External chest wall measurements
时间窗: Change from baseline External chest wall measurements at 12 weeks
External chest wall measurements by chest caliper: Thorax-caliper measurement: Pectus severity index (T.I.): (T3/T1) \* 100 (%) T1: upper edge of the manubrium, T2: Angulus Ludovici , T3: deepest point of the funnel chest, Pectus excavatum: T.I.: \< 110
Anthropometric index
时间窗: Change from baseline Chest anthropometric measurements at 12 weeks
The A measurement was defined as the largest anteroposterior diameter at the level of the distal third of the sternum, and the B measurement was the largest depth at the same level. The anthropometric index (AI)14 for PEX was defined as the B measurement divided by the A measurement (AI = B/A).
The modified percent depth
时间窗: Change from baseline modified percent depth at 12 weeks
At the level of the deepest sternal depression, the sternum, spinous process (posterior midline), and bilateral maximal anterior chest wall projections were marked with temporary ink. The anterior-posterior measurement (cd) is obtained at the lowest depression of the sternum. At the same posterior location the distance from the posterior midline to the right (ad) and left (bd) maximal anterior chest wall projections are recorded. Modified %depth: (ad-cd)/ad\*100
次要结局
- New York Posture Rating Chart for posture assessment(Change from baseline score of New York Posture Rating Chart at 12 weeks)
- The Nuss Questionnaire modified for Adults (Patient form)(Change from baseline score of The Nuss Questionnaire modified for Adults (Patient form) at 12 weeks)
- The Nuss Questionnaire modified for Adults (Parent form)(Change from baseline score of The Nuss Questionnaire modified for Adults (Parent form) at 12 weeks)