SAFE Early Intervention for At-Risk Infants (SAFE-EFFECT)
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
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ankara
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Ankara, Ankara, Turkiet (Türkiye), 06490
- Rekrytering
- Gazi University Faculty of Health Sciences
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Kontakt:
- Bülent Elbasan
- Telefonnummer: +905324672923 +9053
- E-post: bulentelbasan@gazi.edu.tr
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Huvudutredare:
- Ecem Yıldız Çangur, PT, MSc
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent
Exclusion Criteria:
- Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: SAFE EARLY İNTERVENTION group
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.
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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
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Aktiv komparator: NDT TREATMENT GROUP
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
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Conventional neurodevelopmental treatment approach focusing on postural control, motor development, and functional movement patterns during 8 weeks, 5days/week
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hand Assessment for Infants (HAI)
Tidsram: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
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Peabody Developmental Motor Scales - Second Edition (PDMS-2)
Tidsram: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Canadian Occupational Performance Measure (COPM)
Tidsram: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
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PedsQL™ Infant Quality of Life Scale (1-12 Months)
Tidsram: Baseline and after 8 weeks of intervention
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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.
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Baseline and after 8 weeks of intervention
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Mentala störningar
- Patologiska processer
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Obstetrisk förlossning, för tidigt
- Obstetriska förlossningskomplikationer
- Graviditetskomplikationer
- Patologiska tillstånd, tecken och symtom
- För tidig födsel
- Sjukdom
- Neuropsykiatriska funktionsnedsättningar
Andra studie-ID-nummer
- 2026 - 86
- thesis (Gazi University)
Plan för individuella deltagardata (IPD)
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