PretermHEP®-PretermNCT07727720
HEP® Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study
A study testing HEP® Tele-Rehabilitation Intervention in people with Preterm, run by Izgi Miray Demirbag at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Preterm
- What is being tested?
- HEP® Tele-Rehabilitation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm
- Being tested
- HEP® Tele-Rehabilitation Intervention
- Keywords
- Tele-rehabilitation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEP® Tele-Rehabilitation InterventionBehavioural
Also called Homeostasis-Environmental Enrichment-Plasticity Approach
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.
| Study group | Role | What they receive |
|---|---|---|
| HEP® Tele-Rehabilitation Intervention | Experimental | 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. Receives: Behavioral: HEP® Tele-Rehabilitation Intervention |
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 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.
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.
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.
Ages and Stages Questionnaires: Social-Emotional (ASQ:SE)
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
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 posted27 Jul 2026
- Study start1 Nov 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izgi Miray Demirbag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Izgi Miray Demirbag, Medipol University
- Investigators
- Aymen Balıkcı, Dr. Physiotherapist, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727720
- Sponsor's protocol ID
- E-10840098-202.3.02-736
- Acronym
- HEP®-Preterm
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant consent does not include sharing data with other researchers. Data will be maintained in strict confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of HEP® (Homeostasis-Enrichment-Plasticity) Tele-Rehabilitation for Preterm Infants at Developmental Risk
- ClinicalTrials.gov ID
- NCT07727720
- Acronym / sponsor ID
- HEP®-Preterm / E-10840098-202.3.02-736
- Conditions
- Preterm
- Keywords
- Tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Izgi Miray DemirbagUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 27 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| HEP® Tele-Rehabilitation Intervention | Experimental | Behavioral: HEP® Tele-Rehabilitation InterventionThis 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. |
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| HEP® Tele-Rehabilitation InterventionAlso: Homeostasis-Environmental Enrichment-Plasticity ApproachThis 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. | Behavioural | HEP® Tele-Rehabilitation Intervention |
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 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.
Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: 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.
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.
Ages and Stages Questionnaires: Social-Emotional (ASQ:SE)
Time frame: 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
Young Children's Participation and Environment Measure (YC-PEM)
Time frame: 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.
The Goal Attainment Scale (GAS)
Time frame: 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."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Participant consent does not include sharing data with other researchers. Data will be maintained in strict confidentiality.
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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 study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEP® Tele-Rehabilitation Intervention in people with Preterm, run by Izgi Miray Demirbag 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 7 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 27 Jul 2026.