PrematurityHEP-PretermNCT07725367
HEP® Delivered Via Telerehabilitation for Preterm Infants With Developmental Risks
A study testing Homeostasis-Enrichment-Plasticity (HEP®) Approach in people with Prematurity and Developmental Delays, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Preterm infants are at increased risk for developmental delays, making early intervention essential for optimizing developmental outcomes. This study aims to evaluate the effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) approach delivered via telerehabilitation in preterm infants at risk for developmental… Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Prematurity, Developmental Delays
- What is being tested?
- Homeostasis-Enrichment-Plasticity (HEP®) Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2026to 5 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Corrected age 4-12 months. Born at or before 36 weeks and 6 days of gestation. Parents willing to participate regularly and provide informed consent.
Who cannot join
- Major visual or hearing impairment. Genetic syndrome or congenital anomaly. Medical conditions preventing active participation (e.g., oxygen dependency). Participation in another experimental rehabilitation study during the study period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Kavacık Campus
Istanbul, Istanbul, 34810
About this study
Official title: Effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) Approach Delivered Via Telerehabilitation in Preterm Infants at Risk for Developmental Delay: A Randomized Controlled Trial
Preterm infants are at increased risk for developmental delays, making early intervention essential for optimizing developmental outcomes. This study aims to evaluate the effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) approach delivered via telerehabilitation in preterm infants at risk for developmental delay.
Eligible preterm infants will be randomly assigned to either the HEP® telerehabilitation group or the control group receiving usual care. The intervention will be delivered over 12 weeks through weekly online sessions combined with parent coaching and individualized home-based activities.
The study will evaluate the effects of the intervention on infant development, sensory functions, goal attainment, and parental well-being. The findings may provide evidence for the use of family-centered telerehabilitation as an early intervention strategy for preterm infants at developmental risk.
Read the detailed description
Preterm infants are at increased risk for developmental delays due to biological immaturity and environmental factors that may adversely affect neurodevelopment during early life. Early intervention programs that actively involve families and provide enriched developmental experiences are recommended to optimize developmental outcomes during this critical period.
The Homeostasis-Enrichment-Plasticity (HEP®) approach is a family-centered early intervention model that integrates principles of homeostasis, environmental enrichment, and neuroplasticity to support infant development through individualized, embedded in daily routines. Delivering this intervention via telerehabilitation may improve accessibility, promote caregiver engagement, and facilitate continuous professional support regardless of geographical barriers.
This randomized controlled trial aims to evaluate the effectiveness of the HEP® approach delivered via telerehabilitation in preterm infants at risk for developmental delay. Participants will be randomly assigned to either the HEP® telerehabilitation intervention or a control group receiving usual care. The intervention will be provided over a 12-week period through weekly online sessions and individualized home-based activities supported by parent coaching. Developmental, sensory, and family-related outcomes will be assessed to determine the effectiveness and feasibility of the intervention.
- Conditions
- Prematurity, Developmental Delays
- Being tested
- Homeostasis-Enrichment-Plasticity (HEP®) Approach, Usual Care Group
- Keywords
- HEP, Homeostasis-Enrichment-Plasticity, Telerehabilitation, Early Intervention, Preterm Infant, Developmental Risk, Environmental Enrichment, Neuroplasticity, Pediatric Rehabilitation, Randomized Controlled Trial
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeostasis-Enrichment-Plasticity (HEP®) ApproachBehavioural
Also called HEP® Approach, HEP® Early Intervention Approach
The Homeostasis-Enrichment-Plasticity (HEP®) approach is a family-centered early intervention program delivered via telerehabilitation over 12 weeks. The intervention consists of weekly online sessions conducted by a pediatric physiotherapist and individualized home programs tailored to each infant's developmental needs. The HEP® approach integrates the principles of homeostasis, environmental enrichment, and neuroplasticity through parent coaching, individualized goal-directed activities, environmental adaptations, and embedding developmental opportunities into daily routines. Intervention content is continuously monitored and modified according to the infant's progress and family needs.
Usual Care GroupBehavioural
Also called Standart Care
Participants receive standard pediatric rehabilitation care for 12 weeks. The intervention includes conventional developmental exercises and parent education based on the infant's developmental needs. Home exercises are recommended during weekly follow-up sessions according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| HEP® Telerehabilitation | Experimental | Participants receive the Homeostasis-Enrichment-Plasticity (HEP®) early intervention program delivered via telerehabilitation for 12 weeks through individualized parent coaching and home-based activities. Receives: Behavioral: Homeostasis-Enrichment-Plasticity (HEP®) Approach |
| Usual Care | Active comparator | Participants receive usual care during the 12-week study period. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Infant Motor Profile (IMP)
The IMP is a method designed to evaluate the motor behaviour of infants aged 3 to 18 months corrected age (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.
Measured: At baseline and immediately after the 12-week intervention.
The Alberta Infant Motor Scale (AIMS)
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.
Measured: At baseline and immediately after the 12-week intervention.
Secondary outcomes (5)
The Ages and Stages Questionnaires (ASQ)
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.
Measured: At baseline and immediately after the 12-week intervention.
The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE)
The Ages \& Stages Questionnaires: Social-Emotional (ASQ:SE) was developed as a complementary tool to the ASQ to assess social-emotional development and behavioral concerns in infants. The parent-completed questionnaire evaluates key domains, including self-regulation, adaptability, communication, adaptive behavior, autonomy, and emotional functioning.
Measured: At baseline and immediately after the 12-week intervention.
Depression Anxiety Stress Scales-21 (DASS-21)
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.
Measured: At baseline and immediately after the 12-week intervention.
Young Children's Participation and Environment Measure (YC-PEM)
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.
Measured: At baseline and immediately after the 12-week intervention.
The Goal Attainment Scale (GAS)
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."
Measured: At baseline and immediately after the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start5 Feb 2026
- Primary completion5 Aug 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: an experimental group receiving the HEP® approach delivered via telerehabilitation or a control group receiving usual care. Participants will remain in their assigned group throughout the 12-week study period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izgi Miray Demirbag, Medipol University
- Investigators
- Aymen Balıkcı, Dr. Physiotherapist, Principal investigator, Aymen Balıkcı
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725367
- Sponsor's protocol ID
- E-10840098-202.3.02-2212
- Acronym
- HEP-Preterm
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) Approach Delivered Via Telerehabilitation in Preterm Infants at Risk for Developmental Delay: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725367
- Acronym / sponsor ID
- HEP-Preterm / E-10840098-202.3.02-2212
- Conditions
- Prematurity, Developmental Delays
- Keywords
- HEP, Homeostasis-Enrichment-Plasticity, Telerehabilitation, Early Intervention, Preterm Infant, Developmental Risk, Environmental Enrichment, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm infants are at increased risk for developmental delays, making early intervention essential for optimizing developmental outcomes. This study aims to evaluate the effectiveness of the Homeostasis-Enrichment-Plasticity (HEP®) approach delivered via telerehabilitation in preterm infants at risk for developmental delay.
Eligible preterm infants will be randomly assigned to either the HEP® telerehabilitation group or the control group receiving usual care. The intervention will be delivered over 12 weeks through weekly online sessions combined with parent coaching and individualized home-based activities.
The study will evaluate the effects of the intervention on infant development, sensory functions, goal attainment, and parental well-being. The findings may provide evidence for the use of family-centered telerehabilitation as an early intervention strategy for preterm infants at developmental risk.
Detailed description
Preterm infants are at increased risk for developmental delays due to biological immaturity and environmental factors that may adversely affect neurodevelopment during early life. Early intervention programs that actively involve families and provide enriched developmental experiences are recommended to optimize developmental outcomes during this critical period.
The Homeostasis-Enrichment-Plasticity (HEP®) approach is a family-centered early intervention model that integrates principles of homeostasis, environmental enrichment, and neuroplasticity to support infant development through individualized, embedded in daily routines. Delivering this intervention via telerehabilitation may improve accessibility, promote caregiver engagement, and facilitate continuous professional support regardless of geographical barriers.
This randomized controlled trial aims to evaluate the effectiveness of the HEP® approach delivered via telerehabilitation in preterm infants at risk for developmental delay. Participants will be randomly assigned to either the HEP® telerehabilitation intervention or a control group receiving usual care. The intervention will be provided over a 12-week period through weekly online sessions and individualized home-based activities supported by parent coaching. Developmental, sensory, and family-related outcomes will be assessed to determine the effectiveness and feasibility of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: an experimental group receiving the HEP® approach delivered via telerehabilitation or a control group receiving usual care. Participants will remain in their assigned group throughout the 12-week study period.
| Arm | Type | Receives |
|---|---|---|
| HEP® Telerehabilitation | Experimental | Behavioral: Homeostasis-Enrichment-Plasticity (HEP®) ApproachParticipants receive the Homeostasis-Enrichment-Plasticity (HEP®) early intervention program delivered via telerehabilitation for 12 weeks through individualized parent coaching and home-based activities. |
| Usual Care | Active comparator | Behavioral: Usual Care GroupParticipants receive usual care during the 12-week study period. |
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Corrected age 4-12 months. Born at or before 36 weeks and 6 days of gestation. Parents willing to participate regularly and provide informed consent.
Key exclusion criteria (1 listed)
- Major visual or hearing impairment. Genetic syndrome or congenital anomaly. Medical conditions preventing active participation (e.g., oxygen dependency). Participation in another experimental rehabilitation study during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeostasis-Enrichment-Plasticity (HEP®) ApproachAlso: HEP® Approach, HEP® Early Intervention ApproachThe Homeostasis-Enrichment-Plasticity (HEP®) approach is a family-centered early intervention program delivered via telerehabilitation over 12 weeks. The intervention consists of weekly online sessions conducted by a pediatric physiotherapist and individualized home programs tailored to each infant's developmental needs. The HEP® approach integrates the principles of homeostasis, environmental enrichment, and neuroplasticity through parent coaching, individualized goal-directed activities, environmental adaptations, and embedding developmental opportunities into daily routines. Intervention content is continuously monitored and modified according to the infant's progress and family needs. | Behavioural | HEP® Telerehabilitation |
| Usual Care GroupAlso: Standart CareParticipants receive standard pediatric rehabilitation care for 12 weeks. The intervention includes conventional developmental exercises and parent education based on the infant's developmental needs. Home exercises are recommended during weekly follow-up sessions according to routine clinical practice. | Behavioural | Usual Care |
Primary outcome
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 corrected age (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.
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.
5 secondary outcomes
The Ages and Stages Questionnaires (ASQ)
Time frame: At baseline and immediately after the 12-week intervention.
The Ages & Stages Questionnaires: Social-Emotional (ASQ:SE)
Time frame: At baseline and immediately after the 12-week intervention.
Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: At baseline and immediately after the 12-week intervention.
Young Children's Participation and Environment Measure (YC-PEM)
Time frame: At baseline and immediately after the 12-week intervention.
The Goal Attainment Scale (GAS)
Time frame: At baseline and immediately after the 12-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aymen Balıkcı, Dr. Physiotherapist principal investigator
Aymen Balıkcı
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeostasis-Enrichment-Plasticity (HEP®) Approach in people with Prematurity and Developmental Delays, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Infant Motor Profile (IMP) (time frame: At baseline and immediately after the 12-week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.