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

Kahramanmaraş Sütçü İmam University (KSU)

Status: Enrolling

Conditions: Infants Admitted to Neonatal Units; Family Centered; Preterm; Physiotherapy and Rehabilitation

Treatments: Other: Early Physiotherapy Program; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT07201805

Early PT on Motor Optimality

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 5 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Early Physiotherapy Program

Experimental group

Description:

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.

Treatment:

Other: Early Physiotherapy Program

Standard of care

Other group

Description:

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.

Treatment:

Other: Control group