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.
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06490
- 모병
- Gazi University Faculty of Health Sciences
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연락하다:
- Bülent Elbasan
- 전화번호: +905324672923 +9053
- 이메일: bulentelbasan@gazi.edu.tr
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수석 연구원:
- Ecem Yıldız Çangur, PT, MSc
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hand Assessment for Infants (HAI)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Canadian Occupational Performance Measure (COPM)
기간: 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)
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026 - 86
- THESIS (기타 식별자: Gazi University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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미숙아에 대한 임상 시험
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University Hospitals Cleveland Medical CenterThe Cleveland Clinic; MetroHealth Medical Center모병조산 | 임신 조산 | 무도회(임신) | 임신 프롬 | PROM, 조산아(임신) | 파열/분만 사이의 기간에 대한 Premat Rupture Membranes Preterm Unspec미국