NCT07201805

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kahramanmaras Sutcu Imam University · Academic / Other
• Sex: All
• Age: 2 Months – 5 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Infants Admitted to Neonatal Units
• Preterm
• Physiotherapy and Rehabilitation
• Family Centered

Interventions

Type	Name	Description
OTHER	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 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.
OTHER	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-30
• Completion: 2026-10-30
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: Turkey (Türkiye)