RecruitingNot ApplicableNCT07596147

SAFE Early Intervention for At-Risk Infants

Investigation of the Effectiveness of the SAFE Early Intervention Approach on Upper Extremity Function, Fine Motor Skills, and Quality of Life in High-Risk Infants


Sponsor

Gazi University

Enrollment

34 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 3 MonthsMax Age: 12 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called NDT TREATMENT and a behavioral approach called SAFE Early Intervention Program for people with high risk infant, neurodevelopmental disorder (diagnosis), and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSAFE Early Intervention Program

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

BEHAVIORALNDT TREATMENT

Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week


Locations(1)

Gazi University Faculty of Health Sciences

Ankara, Ankara, Turkey (Türkiye)

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NCT07596147


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