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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07727733
Acronym
HEP®-Preterm
Enrollment
16
Registered
2026-07-27
Start date
2024-10-01
Completion date
2025-04-01
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants at Developmental Risk

Keywords

Premature, Environmental enrichment, Early intervention, Tele-rehabilitation

Brief summary

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.

Detailed description

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.

Interventions

OTHERIntervention

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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The study employed the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention method based on environmental enrichment and delivered through tele-rehabilitation. The HEP® approach is an ecological model designed to provide multidimensional support to infants at developmental risk during the early stages of development. It is grounded in a holistic integration of the biological foundations of development and environmental interactions. The intervention is structured around a theoretical framework that promotes physiological homeostasis, encourages exploration of the environment, and facilitates neuroplasticity. The HEP® approach aims to optimize the developmental potential of infants at risk for developmental difficulties through early, targeted environmental enrichment.

Eligibility

Sex/Gender
ALL
Age
4 Months to 12 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Infant Motor Profile (IMP)At baseline and immediately after the 12-week interventionThe 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

MeasureTime frameDescription
The Alberta Infant Motor Scale (AIMS)At baseline and immediately after the 12-week interventionThe 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.
The Ages and Stages Questionnaires (ASQ)At baseline and immediately after the 12-week interventionThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026