Effect of Rebound Therapy on Ventilatory Functions in Children With Down Syndrome. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
The purpose of this study is to examine the effects of rebound therapy on ventilatory functions in children with Down Syndrome.
详细描述
Down syndrome (DS) is one of the common congenital anomalies associated with a high rate of various medical disorders including congenital cardiac defects, visual and auditory affection, musculoskeletal system, and autoimmune disorders. Respiratory involvement is common in DS and is a leading cause of death. Rebound therapy from quality of mini trampoline provides all benefits of other aerobic exercise without the stress impact usually associated with vigrous activity. Several studies support the use of rebound therapy among different areas while, there is no research conducted on ventilatory functions in children with Down Syndrome. Hence, there is need to study the effect of rebount therapy on ventilatory functions in children with Down Syndrome.
Fourty children with Down syndrome (based on power analysis) from both sexes (9-13 years) will be recruited from different schools of special education. They will be divided randomly into control group (20 children) and study group (20 children). The control group will receive a chest physical therapy protocol that included respiratory exercises and incentive spirometer training. The study group will receive a rebound therapy using mini trampoline.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages will be ranged from 9 to 13 years old.
- •Mild and moderate mental retardation with IQ level between 50-70 based on Stanford-Binet intelligence scale.
- •Functional hearing and vision.
- •Independent standing and walking.
排除标准
- •Symptomatic pain.
- •Musculoskeletal problems or/ atlanto-axial instability.
- •Rheumatic and congenital heart disease
- •History of previous surgical operation
- •Regular participation in any sport activities.
研究组 & 干预措施
Chest Physical Therapy Protocol
Children with Down Syndrome will receive a chest physical therapy exercises
干预措施: Chest Physical Therapy Protocol (Other)
Rebound Therapy Protocol
Children with Down Syndrome will receive a chest physical therapy exercises in addition to rebound therapy using mini trampoline.
干预措施: Chest Physical Therapy Protocol (Other)
Rebound Therapy Protocol
Children with Down Syndrome will receive a chest physical therapy exercises in addition to rebound therapy using mini trampoline.
干预措施: Rebound Therapy Protocol (Other)
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: Up to 12 weeks
Spirometry will be used to measure forced vital capacity (FVC). It is the maximum volume of gas that can be expired when the child exhales as forcefully and as rapidly as possible after a maximal inspiration to assess the overall ability to move air in and out of the lungs. It is expressed in liter/minute.
Forced Expiratory Volume in the First Second (FEV1)
时间窗: Up to 12 weeks
Spirometry will be used to measure forced expiratory volume in the first second (FEV1). It is the volume of gas expired over a given time interval (the first second) from the beginning of the FVC maneuver that reflects airflow in the large airways. It is expressed in liter/minute.
次要结局
- Chest Expansion(Up to 12 weeks)
- Functional Mobility(Up to 12 weeks)
研究者
Eman Wagdy
Assistant Professor
Beni-Suef University