Physiotherapy of At-Risk Infants, Physiotherapist or Family? A Randomized Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Hammersmith Infant Neurological Examination (HINE)
研究概览
简要总结
Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants.
详细描述
Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants. Eighteen at-risk infants between the ages of 0 and 12 months were assigned to the preterm and term groups according to their gestational and corrected age. Each group received GDNT for 45 min, three days per week for 12 weeks. The effectiveness of the therapy was measured using Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE), and Goal Attainment Scale (GAS).
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
- — 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being diagnosed as "at-risk" by a pediatric neurologist, having intraventricular hemorrhage, periventricular leucomalacia, hypoxic ischemic encephalopathy, and prematurity, Apgar score of 5 or less at 5 min, chronic lung disease, seizures, meningitis, hyperbilirubinemia, being twins or triplets, and having intrauterine growth restriction;
- •being outside of the neonatal intensive care unit;
- •being between 0 and 12 months old (corrected age for premature infants);
- •having a family acceptance for the participation in 12 weeks of therapy program.
排除标准
- •having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and
- •lack of informed content by the parents.
结局指标
主要结局
Hammersmith Infant Neurological Examination (HINE)
时间窗: 12 weeks
It includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour.The data obtained in the second and third sections are not included in the calculation of global optimality scores. The overall score ranges from a minimum of 0 to a maximum of 78. At 9 or 12 months, the scores equal or above 73 are regarded as optimal, if below 73 as sub-optimal; while at 3 and 6 months healthy term infants scored equal or above 67 and 70 (median) respectively.
Goal Attainment Scale (GAS)
时间窗: 12 weeks
GAS methods required practitioners to set rehabilitation goals in collaboration with the client and family. or significant others, such as a carer. For each goal, the client and practitioner developed detailed and very specific observable and quantifiable descriptions of possible outcomes Five outcome levels were identified,including the expected or desired level of performance or outcome, 2 levels that would be seen as less favourable and 2 levels that were more favourable. The 5 recommended outcome levels for each goal were assigned numeric values from -2 (the least favourable outcome) to +2 (the most favourable outcome). The expected outcome or goal was assigned 0.
Alberta Infant Motor Scale (AIMS)
时间窗: 12 weeks
This scale is a norm-referenced observational tool designed for the evaluation of gross motor development in infants from birth to 18 months of age or the acquisition of independent walking. It consists of 58 items and four subscales: supine (9 items), prone (21 items), sitting (12 items) and standing (16 items), which are observed in postural alignment, antigravity movements and surface contact.The obtained score (0-60 points) was converted to a normative age-dependent percentile rank (5th,10th,25th, 50th, 75th or 90th percentiles). A score less than the 10th percentile was classified as possibly delayed motor development.
次要结局
未报告次要终点
研究者
Nilay Comuk Balci
Pt, PhD
Hacettepe University