An interventional study of SAFE Early Intervention Program and NDT TREATMENT in High Risk Infant, Neurodevelopmental Disorder (Diagnosis) and Preterm, sponsored by Gazi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Gazi University · Not applicable, Interventional, and Treatment
This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group.
Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities.
Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills.
Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.
This randomized controlled study investigates the effects of two different early intervention approaches in high-risk infants. The SAFE intervention program is compared with conventional Neurodevelopmental Treatment (NDT). Assessments include upper extremity function, fine motor development, and developmental outcomes measured at baseline and follow-up periods. The study aims to determine which intervention provides superior improvement in early motor and developmental skills.
Exclusion Criteria:
SAFE-based early intervention for high-risk infants: The SAFE early intervention approach will be implemented to improve proximal stabilisation in high-risk infants aged between 3 and 12 months.
Behavioral: SAFE Early Intervention Program
Neurodevelopmental Treatment (NDT): The NDT approach, which aims to develop fine motor skills in high-risk infants aged between 3 and 12 months, will be implemented
Behavioral: NDT TREATMENT
Structured early intervention program designed for high-risk infants focusing on upper extremity function, fine motor development, and neurodevelopmental outcomes during 8 weeks, 5 days/week
Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week
Hand Assessment for Infants (HAI)
he Hand Assessment for Infants (HAI) will be used to evaluate upper extremity and hand function in high-risk infants through observational video analysis. The assessment includes reaching, grasping, object manipulation, bilateral hand use, and spontaneous hand movements during structured play activities.
Time frame: Baseline and after 8 weeks of intervention
Peabody Developmental Motor Scales - Second Edition (PDMS-2)
The Peabody Developmental Motor Scales - Second Edition (PDMS-2) will be used to assess gross and fine motor development in high-risk infants aged 3-12 months. The assessment includes reflexes, stationary skills, locomotion, object manipulation, grasping, and visual-motor integration. Higher scores indicate better motor performance and developmental function.
Time frame: Baseline and after 8 weeks of intervention
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) will be used to evaluate parent-perceived performance and satisfaction related to the infant's functional goals. Parents will identify important activity-related goals and rate performance and satisfaction using a 10-point scale. Higher scores indicate better occupational performance and greater parental satisfaction.
Time frame: Baseline and after 8 weeks of intervention
PedsQL™ Infant Quality of Life Scale (1-12 Months)
The PedsQL™ Infant Quality of Life Scale will be used to assess health-related quality of life in infants based on parent report. The scale evaluates physical functioning, emotional status, social interaction, and general well-being. Higher scores indicate better quality of life.
Time frame: Baseline and after 8 weeks of intervention
Plan to share: No
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Gazi University