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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Ankara
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Ankara、Ankara、トルコ（Türkiye）、06490
- 募集
- Gazi University Faculty of Health Sciences
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コンタクト：
- Bülent Elbasan
- 電話番号：+905324672923 +9053
- メール：bulentelbasan@gazi.edu.tr
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主任研究者：
- Ecem Yıldız Çangur, PT, MSc
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hand Assessment for Infants (HAI)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Canadian Occupational Performance Measure (COPM)
時間枠：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)
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026 - 86
- THESIS (その他の識別子：Gazi University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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