RecruitingNot ApplicableNCT07201805

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

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


Sponsor

Kahramanmaras Sutcu Imam University

Enrollment

50 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 MonthsMax Age: 5 Months

Inclusion Criteria3

  • 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

Exclusion Criteria1

  • 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.)

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Interventions

OTHEREarly 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 model of active motor learning and sensory strategy development for the baby in an enriched environment, incorporating holding, carrying, and positioning into daily routines. If possible, the entire family will participate in these programs.

OTHERControl 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.


Locations(1)

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubet, Turkey (Türkiye)

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NCT07201805


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