Actively Recruiting
Effects of Early Physiotherapy on Motor Optimality Score in At-Risk Infants: A Randomized Controlled Study
Led by Kahramanmaras Sutcu Imam University · Updated on 2025-10-01
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Advances in neonatal care have improved survival rates for very low birth weight infants but have led to increased rates of conditions such as cerebral palsy, cardiorespiratory disorders, blindness, cognitive delays, and hearing impairments. Early diagnosis and intervention programs in neonatal intensive care units (NICU) aim to support the development of these at-risk infants by normalizing their motor, cognitive, and sensory skills. This study focuses on evaluating the effects of early family-involved physiotherapy on motor development in infants at risk after NICU discharge, using tools like Prechtl's General Movements Assessment and the Motor Optimality Score - Revised (MOS-R). Participants will be randomly assigned to either an early physiotherapy program or a control group. The intervention group will receive a tailored family collaborative physiotherapy program including education on handling, carrying, positioning, and sucking facilitation to stimulate postural responses, integrated into daily routines. The control group will receive routine developmental NICU care plus a one-time instruction on positioning and carrying at discharge. The program continues with family recommendations until the infant reaches the study's evaluation points. Participants will be assessed for motor skills using the Motor Optimality Score and Prechtl's General Movements Assessment between 12 and 20 weeks postterm. Additional evaluations include neurological exams (Hammersmith Neonatal and Infant Neurological Examinations) and cognitive and language development assessments (BAYLEY-III) at 3 and 6 months corrected age. Sociodemographic data will be collected at baseline. The study aims to measure the impact of early physiotherapy on neurological and developmental outcomes in at-risk infants within a 4-month age range.
CONDITIONS
Brief Title
Effects of Early Physiotherapy on Motor Optimality Score in At-Risk of Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants diagnosed with periventricular hemorrhage, intracranial hemorrhage, cystic periventricular leukomalacia, hypoxic-ischemic encephalopathy, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis, retinopathy of prematurity, respiratory distress syndrome, bronchopulmonary dysplasia, or those receiving oxygen or mechanical ventilation support
- Infants with a 5-minute Apgar score less than 3
- Infants born before 37 weeks gestation
- Infants with birth weight less than 1500 grams or prematurity due to multiple births
- Infants with corrected age between 2 and 4 months
You will not qualify if you...
- Infants with congenital malformations such as spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita
- Infants diagnosed with metabolic or genetic diseases including Down syndrome, spinal muscular atrophy, Duchenne muscular dystrophy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until discharge from the NICU with family recommendations
Participants receive an early physiotherapy program tailored to the needs of at-risk infants or routine developmental NICU care with one-time instruction on positioning and holding at discharge.
1 baseline visit and follow-up assessments
Duration - From 2 months to 6 months of corrected age
Participants attend follow-up visits to assess motor development and neurological outcomes through standardized assessments over several months.
Visits at 2, 3, and 6 months of corrected age
Trial Site Locations
Total: 1 location
1
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubet, Turkey (Türkiye), 46100
Actively Recruiting
Research Team
H
hatice adıgüzel tat, Associate Proffessor
H
hatice Adiguzel tat, Associate Proffessor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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