NCT07201805 Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants
| NCT ID | NCT07201805 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kahramanmaras Sutcu Imam University |
| Condition | Infants Admitted to Neonatal Units |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07201805 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 5 Months, studying Infants Admitted to Neonatal Units. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07201805 currently recruiting?
Yes, NCT07201805 is actively recruiting participants. Contact the research team at fzthatis@gmail.com for enrollment information.
Where is the NCT07201805 trial being conducted?
This trial is being conducted at Kahramanmaraş, Turkey (Türkiye).
Who is sponsoring the NCT07201805 clinical trial?
NCT07201805 is sponsored by Kahramanmaras Sutcu Imam University. The trial plans to enroll 50 participants.