HEP® Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study (HEP®-Preterm)
2026年7月21日 更新者：Izgi Miray Demirbag
Feasibility Study of HEP® (Homeostasis-Enrichment-Plasticity) Tele-Rehabilitation for Preterm Infants at Developmental Risk
Several early intervention approaches based on sensory and motor environmental enrichment have demonstrated neurobehavioral benefits and improvements in motor and cognitive skills in infants.
Tele-rehabilitation has also been shown to positively impact the motor and cognitive development of at-risk infants.
However, limited research has examined the effects of environmental enrichment-based early interventions delivered via tele-rehabilitation on sensory, motor, cognitive, language, and socio-emotional skills, adaptive behaviors, parental goals, and parental anxiety in preterm infants at developmental risk, as well as the feasibility of delivering such interventions online.
The proposed study aims to evaluate the effects of the environmental enrichment-based HEP® approach delivered through tele-rehabilitation on these developmental outcomes in preterm infants, thereby contributing to the existing literature.
調査の概要
詳細な説明
In our study, 16 infants meeting the inclusion criteria received a tele-rehabilitation intervention based on the environmental enrichment-oriented HEP® approach. This was a single-group feasibility study, with no separate control group. The infants were re-evaluated using the same assessment methods before and after the intervention.
The initial and final assessments took place entirely online, and the assessor was different from the person delivering the intervention. The intervention lasted 12 weeks and was conducted entirely online, with 45-minute sessions delivered according to environmental enrichment principles. Parent training was also provided to support the implementation of the intervention at home.
Infants' demographic, perinatal, natal, and postnatal information was collected via a "Demographic Information Form" prepared by the researcher. Motor capacities were evaluated using the Infant Motor Profile (IMP) and the Alberta Infant Motor Scale (AIMS). Parents' depression, anxiety, and stress levels were measured with the Depression Anxiety Stress Scale (DASS-21). Additionally, parents completed the Ages & Stages Questionnaires (ASQ) to assess their child's gross motor, fine motor, problem-solving, communication, and personal-social development; the Ages & Stages Questionnaires®: Social-Emotional (ASQ:SE®) to evaluate socio-emotional and behavioral difficulties; and the Young Children's Participation and Environment Measure (YC-PEM) to evaluate their child's participation in various activities. Individualized goals for each infant were established at the beginning of the intervention using the Goal Attainment Scale (GAS). At the end of the intervention, parents also completed the Social Validity Form developed by the researcher.
All assessments and the intervention were conducted online.
研究の種類
介入
入学 (実際)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beykoz
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Istanbul、Beykoz、トルコ（Türkiye）、34810
- Sense On
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Infants with a corrected age between 4 and 12 months.
- Infants born at or before 36 weeks and 6 days of gestation.
- Infants with no congenital anomalies.
- Families who agree to participate regularly in the study process.
Exclusion Criteria:
- Infants with major visual or hearing impairments.
- Infants with any genetic syndrome or congenital anomalies.
- Infants with medical conditions that prevent active participation in the study (e.g., oxygen dependence).
- Infants participating in other experimental rehabilitation studies.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：HEP® Tele-Rehabilitation Intervention
This arm includes infants receiving the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention program delivered entirely online through tele-rehabilitation.
The intervention is conducted in 45-minute sessions over 12 weeks, following environmental enrichment principles.
Parent training is provided to support the implementation of activities at home, and individualized developmental goals are established for each infant at the beginning of the intervention.
All assessments and the intervention are conducted online.
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This group receives the HEP® Tele-Rehabilitation Intervention, an early intervention program based on the Homeostasis-Environmental Enrichment-Plasticity approach and delivered entirely through tele-rehabilitation.
The intervention consists of 45-minute online sessions conducted weekly over 12 weeks and follows environmental enrichment principles.
Parent training is provided to support the implementation of activities in the home environment, and individualized developmental goals are established for each infant at the beginning of the intervention.
All assessments and intervention procedures are conducted remotely via online platforms.
他の名前：
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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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The Alberta Infant Motor Scale (AIMS)
時間枠：At baseline and immediately after the 12-week intervention.
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The Alberta Infant Motor Scale (AIMS) is a standardized assessment designed to evaluate motor development in infants.
It specifically measures both fine and gross motor skills across a range of developmental stages.
This assessment provides valuable information regarding infants' physical abilities and developmental progress.
The test typically takes approximately 15 minutes to administer, and scores are interpreted by comparison with a normative database.
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At baseline and immediately after the 12-week intervention.
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The Ages and Stages Questionnaires (ASQ)
時間枠：At baseline and immediately after the 12-week intervention.
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The ASQ is a developmental screening tool that enables parents to assess an infant's developmental progress.
The questionnaire comprises three sections: demographic information, a 30-item developmental section, and seven open-ended questions.
The 30-item section evaluates five developmental domains-communication, fine motor skills, gross motor skills, problem-solving, and personal-social development-each domain consisting of six questions.
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At baseline and immediately after the 12-week intervention.
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Depression Anxiety Stress Scales-21 (DASS-21)
時間枠：At baseline and immediately after the 12-week intervention.
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The DASS-21 is a validated and reliable tool for screening depressive and anxiety disorders, and it effectively assesses the severity of three psychological states through 21 items.
The scale consists of three subscales: depression (7 items), anxiety (7 items), and stress (7 items).
Each item is rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
Lower scores on the subscales indicate better psychological well-being.
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At baseline and immediately after the 12-week intervention.
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Young Children's Participation and Environment Measure (YC-PEM)
時間枠：At baseline and immediately after the 12-week intervention.
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The YC-PEM is a parent-completed measure designed to assess the level and quality of participation of children aged 0-5 years in various activities and the environments in which these activities take place.
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At baseline and immediately after the 12-week intervention.
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The Goal Attainment Scale (GAS)
時間枠：At baseline and immediately after the 12-week intervention.
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The Goal Attainment Scale (GAS) is the most commonly recommended goal-setting methodology for measuring change during and after intervention in clinical and research applications.
The GAS, which assesses the child's achievement of individual goals established with parents at the beginning of the intervention, is a reliable tool for children with developmental challenges and provides subjective information about the child's needs.
The GAS has a rating scale of "-2" to "+2."
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At baseline and immediately after the 12-week intervention.
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The Infant Motor Profile (IMP)
時間枠：At baseline and immediately after the 12-week intervention.
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The IMP is a method designed to evaluate the motor behaviour of infants aged 3 to 18 months CA.
The IMP is based on a video recording of a semi-standardized play session of about 15 minutes, during which an assessor plays with the infant in such a way that the IMP items can be assessed.
This means that the playing assessor has knowledge of the IMP items, allowing her to adapt the assessment to the infant's functional abilities and the IMP needs.
The 80 items of the IMP evaluate motor behaviour in supine and prone positions; while sitting, standing, and walking; when reaching and grasping; and during manipulation.
It is a discriminative, evaluative, and predictive measurement.
The IMP has been developed for health care professionals working in the feld of early detection of developmental disorders and early intervention.
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At baseline and immediately after the 12-week intervention.
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Ages and Stages Questionnaires: Social-Emotional (ASQ:SE)
時間枠：At baseline and immediately after the 12-week intervention.
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The ASQ:SE was developed as a complementary tool to the ASQ to assess social-emotional development and behavioral difficulties in infants.
The questionnaire is completed by parents and evaluates key domains, including self-regulation, adaptability, communication, adaptive behavior, autonomy, emotional status, and interactions with
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At baseline and immediately after the 12-week intervention.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Aymen Balıkcı, Dr. Physiotherapist
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年11月1日
一次修了 (実際)
2025年3月1日
研究の完了 (実際)
2025年3月1日
試験登録日
最初に提出
2025年11月13日
QC基準を満たした最初の提出物
2026年7月21日
最初の投稿 (実際)
2026年7月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月27日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- E-10840098-202.3.02-736
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?
いいえ
IPD プランの説明
Participant consent does not include sharing data with other researchers.
Data will be maintained in strict confidentiality.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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