Early physiotherapy to improve motor optimality in at-risk infants
Official title: Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants: A Double-Blind Randomized Controlled Study
Run by Kahramanmaras Sutcu Imam University · NCT07201805 · Data updated 2026-11-12
This trial will test whether starting a targeted physiotherapy program early improves motor movement scores in infants born preterm or who had serious neonatal complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Months to 5 Months |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş, Onikişubet) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT07201805 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants who are 2–4 months corrected age and were born preterm (<37 weeks or <1500 g) or had neonatal complications such as intracranial hemorrhage, HIE, NEC, sepsis, RDS/BPD, ROP, or required oxygen or mechanical ventilation.
✕Probably not a fit
Infants with major congenital malformations or known genetic/metabolic disorders (for example spina bifida, Down syndrome, spinal muscular atrophy) and infants outside the 2–4 month corrected age window are unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll infants at 2–4 months corrected age who were born preterm or experienced significant neonatal complications and assign them to an early physiotherapy program or to standard care. The intervention combines therapist-delivered sessions and parent‑guided exercises focused on movement quality and handling, delivered in the neonatal follow-up setting. Motor outcomes will be measured using the Motor Optimality Score and general movements recordings at baseline and follow-up visits. The trial compares change in motor development between the intervention and control groups to see if early physiotherapy improves movement quality.
Why it matters
Potential benefit: If successful, the program could improve early motor function and reduce the risk of long-term motor disabilities such as cerebral palsy.
How similar studies have gone: Prior early-intervention programs, especially those that involve parents, have shown improvements in motor development and longer-term cognitive and language outcomes, although the optimal specific physiotherapy approaches remain uncertain.
Who can join: the full rules
Show full inclusion / exclusion 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.)
Where it's running
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Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubet, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: hatice adıgüzel tat, Associate Proffessor
- Email: fzthatis@gmail.com
- Phone: +903443002647
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.