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HEP® Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study (HEP®-Preterm)

21 июля 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

16

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: HEP® Tele-Rehabilitation Intervention
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.
Другие имена:
  • Homeostasis-Environmental Enrichment-Plasticity Approach

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
The Alberta Infant Motor Scale (AIMS)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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.
At baseline and immediately after the 12-week intervention.
The Ages and Stages Questionnaires (ASQ)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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.
At baseline and immediately after the 12-week intervention.
Depression Anxiety Stress Scales-21 (DASS-21)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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.
At baseline and immediately after the 12-week intervention.
Young Children's Participation and Environment Measure (YC-PEM)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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.
At baseline and immediately after the 12-week intervention.
The Goal Attainment Scale (GAS)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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."
At baseline and immediately after the 12-week intervention.
The Infant Motor Profile (IMP)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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.
At baseline and immediately after the 12-week intervention.
Ages and Stages Questionnaires: Social-Emotional (ASQ:SE)
Временное ограничение: At baseline and immediately after the 12-week intervention.
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
At baseline and immediately after the 12-week intervention.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Izgi Miray Demirbag

Следователи

  • Директор по исследованиям: Aymen Balıkcı, Dr. Physiotherapist

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 ноября 2024 г.

Первичное завершение (Действительный)

1 марта 2025 г.

Завершение исследования (Действительный)

1 марта 2025 г.

Даты регистрации исследования

Первый отправленный

13 ноября 2025 г.

Впервые представлено, что соответствует критериям контроля качества

21 июля 2026 г.

Первый опубликованный (Действительный)

27 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • E-10840098-202.3.02-736

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Participant consent does not include sharing data with other researchers. Data will be maintained in strict confidentiality.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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