Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants: A Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score
研究概览
简要总结
Medical and technological advances in neonatal care have led to a decrease in neonatal mortality and an increase in the survival of very low birth weight infants, leading to a global increase in the prevalence of cerebral palsy (CP), cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Early diagnosis and intervention programs have been established to meet the developmental needs of these at-risk infants in the neonatal intensive care unit (NICU). The goal of these programs is to facilitate the development of at-risk infants and normalize their motor, cognitive, and sensory development.Research remains unclear about which interventions are more effective when implemented. It is known that early intervention improves motor development in these infants, and that programs that include parents have more positive long-term outcomes for the cognitive and language development of at-risk infants.General Movements (GMs) are spontaneous movements that occur from the fetal period to 18 weeks postterm. Prechtl's General Movements Assessment (GMA) is a reliable tool for functional assessment of the young central nervous system.The assessment of motor repertoire (via the motor optimality score, MOS) describes the quality and quantity of the concurrent motor repertoire recorded during the GM assessment.The revised motor optimality score (MOS-R) has the potential to increase the prediction of adverse neurodevelopmental outcomes. It is noteworthy that the literature contains limited studies examining the effect of early physiotherapy applied to at-risk infants after NICU discharge on MOS-R. Therefore, the aim of this planned study was to investigate the effect of early family collaborative physiotherapy approaches applied to at-risk infants after NICU discharge on GMs MOS-R. Another aim was to determine the effect of early physiotherapy on neurological examination, cognitive, and language development in infants at 3 and 6 months of age and to compare them with similar peers receiving a routine treatment protocol.
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
- 2 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD, and those receiving oxygen or mechanical ventilation (MV) support
- •Infants with a 5-minute Apgar score <3, <37 weeks' gestation, <1500 grams of preterm birth, or prematurity due to multiple births.
- •Infants with the corrected age of 2 to 4 months
排除标准
- •Infants with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)
研究组 & 干预措施
Early Physiotherapy Program
A physiotherapy program tailored to the needs of infants from families who volunteer to participate will be implemented until and with family recommendations at the time of discharge. Parents of all at-risk infants will receive advice on handling, carrying, and positioning at the time of discharge.
干预措施: Early Physiotherapy Program (Other)
Standard of care
Babies from families unable to attend physiotherapy for any reason (working parents, those unable to attend treatment sessions, or those living out of town) will constitute the control group, provided they are available for evaluation. The control group will receive routine developmental NICU care, as well as one-time instruction in positioning and holding and carrying principles upon discharge.
干预措施: Control group (Other)
结局指标
主要结局
Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score
时间窗: postterm 12th to 20 weeks of age
All babies will have their Motor Optimality Scores (MOS-R) calculated at the end of the 4th and 5th months, adjusted for fidgety General Movements of the videos. The MOS-R assesses movement repertoire and scores in the following four areas.The total of these scores varies between 5 and 28. Higher scores shows better developmental status.
Pretchl's General Movements (GMs) Assesment
时间窗: after the postterm 8th weeks of age and after the postterm weeks of 12 to 20 weeks
General movements (GMs) are the spontaneous repertoire of movements present from early fetal life until the 20th week postpartum. They are writhing until the 8th week postpartum and then fidgety until approximately the 20th week.Video recordings will begin in the NICU three days after birth in the preterm period. All infants will be examined for writhing and fidgety movements (FM) via video recordings.Movements during the preterm and writhing periods will be classified as PR, CS, and Ch GMs or normal. Movements during the fidgety period will be recorded as F+ or F++ when normal, AF when abnormal, or F- when not observed.
Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score
时间窗: postterm 12th to 20 weeks of age
All babies will have their Motor Optimality Scores (MOS-R) calculated at the end of the 4th and 5th months, adjusted for fidgety General Movements of the videos. The MOS-R assesses movement repertoire and scores in the following four areas.The total of these scores varies between 5 and 28. Higher scores shows better developmental status.
Pretchl's General Movements (GMs) Assesment
时间窗: after the postterm 8th weeks of age and after the postterm weeks of 12 to 20 weeks
General movements (GMs) are the spontaneous repertoire of movements present from early fetal life until the 20th week postpartum. They are writhing until the 8th week postpartum and then fidgety until approximately the 20th week.Video recordings will begin in the NICU three days after birth in the preterm period. All infants will be examined for writhing and fidgety movements (FM) via video recordings.Movements during the preterm and writhing periods will be classified as PR, CS, and Ch GMs or normal. Movements during the fidgety period will be recorded as F+ or F++ when normal, AF when abnormal, or F- when not observed.
次要结局
- BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)(3th and 6th months of corrected age)
- Hammersmith Neonatal Neurological Examination (HNNE)(from birth to 42 weeks of age)
- Hammersmith Infant Neurological Examination (HINE)(2th, 3th, 6th months of corrected age)
- Sociodemographic form(baseline)
- Hammersmith Neonatal Neurological Examination (HNNE)(from birth to 42 weeks of age)
- Hammersmith Infant Neurological Examination (HINE)(2th, 3th, 6th months of corrected age)
- BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)(3th and 6th months of corrected age)
- Sociodemographic form(baseline)
研究者
Hatice Adiguzel
Associate profesor
Kahramanmaras Sutcu Imam University