Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants

Официальное название

Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants: A Double-Blind Randomized Controlled Study

Обзор

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.

Вмешательства

• Другое Early Physiotherapy Program
  The physiotherapy program provided upon discharge will consist of family education programs that include parental contact and therapeutic holding, carrying, positioning, and sucking facilitation to stimulate postural responses. The physiotherapist will provide training to integrate these programs into daily routines. The physiotherapy group will receive a routine-based family collaborative early intervention program. This program will consist of family education programs based on a goal-oriented
• Другое Control group
  The control group will be shown one-time positioning and holding and carrying principles in addition to routine developmental NICU care at the time of discharge.

Первичные конечные точки

• Motor Optimality Score for 3-to 5-Month-Old Infants - Revised and Motor Repertoire Score [Срок оценки: postterm 12th to 20 weeks of age]
• Pretchl's General Movements (GMs) Assesment [Срок оценки: after the postterm 8th weeks of age and after the postterm weeks of 12 to 20 weeks]

Вторичные конечные точки (4)

• Hammersmith Neonatal Neurological Examination (HNNE) [Срок оценки: from birth to 42 weeks of age]
• Hammersmith Infant Neurological Examination (HINE) [Срок оценки: 2th, 3th, 6th months of corrected age]
• BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III) [Срок оценки: 3th and 6th months of corrected age]
• Sociodemographic form [Срок оценки: baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Kahramanmaraş Sütçü imam University — Kahramanmaraş

Идентификаторы

NCT: NCT07201805 · Early PT on Motor Optimality

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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