Fidgety Movements Analysis in Infants With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Motor Optimality Score (MOS)
研究概览
简要总结
Very low birth weight infants who are at risk for chronic lung diseases may also be at risk for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage. Infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental outcomes than healthy infants. It has also been pointed out that babies with prolonged and recurrent apneas during sleep may have weak General Movements (GMs) repertoire.
It has been mentioned that motor development retardation may also occur in neurodevelopmental diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. In infants with cystic fibrosis, motor development may be affected by increased incidence of hospitalization, previous infections, malnutrition, respiratory and digestive system disorders. There is no research done with GMs assessment to determine motor dysfunction in infants with cystic fibrosis and this topic is open to research.
Having more information about the motor development of babies by determining the motor characteristics and motor performance of infants with cystic fibrosis, it may be possible to start the disease-specific physiotherapy and rehabilitation programs as early as possible. For this reasons, in the study the investigators aimed to investigate the characteristics of GMs in the "Fidgety" period of 3-5 month term infants diagnosed with cystic fibrosis, to determine the motor performances and to investigate the relation between the GMs characteristics and the features of the disease.
The hypotheses the investigators have set for this study are listed below;
Ho: Spontaneous movements of the "Fidgety" period of infants diagnosed with 3-5 months of cystic fibrosis are not different from normal infants.
H1: Spontaneous movements of "Fidgety" period of infants diagnosed with cystic fibrosis between 3-5 months are different from normal infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being diagnosed with cystic fibrosis
- •Being between the postterm 3rd and 5th months
排除标准
- •Having congenital anomalies,
- •Having an ongoing infection,
- •Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
- •Fidgety movements evaluation results; being abnormal (AF), sporadic (F +/-) or non-F (F-)
- •Baby's family does not want to be involved in the work
结局指标
主要结局
Motor Optimality Score (MOS)
时间窗: 45 minute for each patient
The MOS has a max. value of 28 (for the best possible performance) and a min. value of 5. The score sheet comprises the following five sub-categories: fidgety movements, age-adequacy of motor repertoire, quality of movement patterns other than fidgety movements, posture, and overall quality of the motor repertoire. 1. Fidgety Movements; normal fidgety: 12 points, abnormal fidgety: 4 points and sporadic fidgety: 1 points 2. Age-adequacy of motor repertoire; normal motor repertoire: 4 points, decreased motor repertoire: 2 points, non age-adequacy of motor repertoire: 1 points 3. Quality of movement patterns other than fidgety movements; normal movement patterns: 4 points, equal normal and abnormal movement patterns: 2 points, abnormal movement patterns: 1 points 4. Posture; normal posture: 4 points, equal normal and abnormal posture: 2 points, abnormal posture: 1 points 5. Overall quality of the motor repertoire; normal: 4 points, abnormal: 2 points, cramped-synchronized: 1 points
次要结局
未报告次要终点
研究者
Akmer Mutlu
Associate Professor
Hacettepe University