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Completed

NCT Number: NCT07727733

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

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.

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Key information

Conditions

Preterm Infants at Developmental Risk Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

4 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sense On , Istanbul, Beykoz 34810

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Other

The HEP® (Homeostasis-Environmental Enrichment-Plasticity) Approach is a child-centered, family-based early intervention program grounded in the principles of homeostasis, environmental enrichment, and neuroplasticity. This approach is based on by ecological and developmental theories, including Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model.

Primary outcomes

  1. The Infant Motor Profile (IMP)

    Time frame: 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.

Secondary outcomes

  1. The Alberta Infant Motor Scale (AIMS)

    Time frame: 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.

  2. The Ages and Stages Questionnaires (ASQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Feasibility Study of HEP® (Homeostasis-Enrichment-Plasticity) Tele-Rehabilitation for Preterm Infants at Developmental Risk

Acronym: HEP®-Preterm

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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