Infants at Risk of Cerebral PalsyNCT07116148
A Randomized Controlled Trial of Hybrid Environmental Enrichment-Based Early Intervention in Infants at Risk of Cerebral Palsy
A study testing HEP-Based Early Intervention and Conventional Early Intervention in people with Infants at Risk of Cerebral Palsy, run by Medipol University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of a hybrid environmental enrichment-based early intervention grounded in the Homeostasis-Enrichment-Plasticity (HEP®) Approach in infants at risk of cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 4 to 10 months
- Conditions the study is for
- Infants at Risk of Cerebral Palsy
- What is being tested?
- HEP-Based Early Intervention and Conventional Early Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Aug 2026
- 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 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants who meet the following criteria will be included in the study:
- According to the general movement assessment, babies from birth to the 8th week have poor repertoire, synchronized cramps or chaotic movement pattern, and the presence of abnormal fidgeting movements between the 6th and 9th weeks.
- A neurologist has detected the presence of abnormal brain imaging on magnetic resonance imaging or cranial ultrasound,
- Absence of congenital anomalies,
- The family agrees to participate regularly in the study.
Who cannot join
- Major vision or hearing problems,
- Presence of any genetic syndrome or congenital anomaly,
- Medical conditions that prevent active participation in the study (such as oxygen dependence),
- Participation in other experimental rehabilitation studies
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sense On, Ltd.
Istanbul, Beykoz, 34810
Sense On
Istanbul, Beykoz, 34810
About this study
Official title: An Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach in Infants at Risk of Cerebral Palsy: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of a hybrid environmental enrichment-based early intervention grounded in the Homeostasis-Enrichment-Plasticity (HEP®) Approach in infants at risk of cerebral palsy (CP). Infants aged 4-10 months identified as being at risk for CP through the Prechtl Assessment or brain imaging will be randomly assigned to either a HEP®-based hybrid environmental enrichment intervention group or a control group receiving conventional intervention. Both groups will receive intervention once weekly for one hour over a 12-week period. Outcomes related to functional goal attainment, developmental performance, and parental well-being will be assessed using the Goal Attainment Scaling (GAS), Bayley Scales of Infant and Toddler Development-III (Bayley-III), Test of Sensory Functions in Infants (TSFI), and Depression Anxiety Stress Scales-21 (DASS-21). Feasibility, safety, and caregiver acceptance of the intervention will also be examined.
Read the detailed description
This randomized controlled trial is designed to evaluate the effects, feasibility, safety, caregiver acceptability, and satisfaction associated with the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention model grounded in the environmental enrichment (EE) paradigm, in infants at risk of cerebral palsy (CP). In addition to examining the clinical effects of the intervention, the study aims to compare a hybrid HEP®-based environmental enrichment intervention with conventional early intervention approaches.
Infants aged 4-10 months corrected age who are identified as being at risk for CP through the Prechtl Assessment of General Movements or abnormal brain imaging confirmed by a pediatric neurologist will be randomly assigned to either the HEP®-based hybrid environmental enrichment intervention group or a control group receiving conventional intervention. Both groups will receive intervention once weekly for one hour over a 12-week period, ensuring equivalence in intervention dosage while differing in therapeutic content.
The HEP® intervention will be implemented as a hybrid model delivered both in the clinical setting and the home environment, integrating principles of homeostasis, environmental enrichment, and neuroplasticity. The control group will receive conventional early intervention approaches routinely used in clinical practice.
Primary and secondary outcomes will include the achievement of individualized functional goals, developmental performance, and parental well-being. Functional goal attainment will be assessed using the Goal Attainment Scaling (GAS). Developmental outcomes will be evaluated using the Bayley Scales of Infant and Toddler Development-III (Bayley-III) and the Test of Sensory Functions in Infants (TSFI). Parental well-being will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21). In addition, feasibility, safety, caregiver acceptability, and satisfaction related to the intervention will be evaluated using a 24-item Likert-type questionnaire developed by the researcher.
- Conditions
- Infants at Risk of Cerebral Palsy
- Being tested
- HEP-Based Early Intervention, Conventional Early Intervention
- Keywords
- Environmental enrichment, early intervention, hybrid model, plasticity, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEP-Based Early InterventionBehavioural
HEP-Based Early Intervention
The Homeostasis-Environmental Enrichment-Plasticity (HEP®) Approach is an ecological and holistic early intervention model based on the environmental enrichment paradigm. The intervention is designed to support infants at developmental risk by promoting physiological homeostasis, encouraging active environmental exploration, and facilitating neuroplasticity through enriched and meaningful experiences. In this study, the HEP approach will be implemented as a hybrid model combining clinic-based and home-based sessions. Intervention content will be individualized according to the infant's developmental needs and functional goals.
Conventional Early InterventionBehavioural
Conventional early intervention will be delivered based on standard therapy practices commonly used in early intervention programs. The intervention will include a range of techniques aimed at improving muscle strength and supporting postural control. Therapeutic handling techniques will be applied by the therapist to prevent maladaptive movement patterns and to facilitate appropriate and functional movement responses. The intervention will be provided once weekly in one-hour sessions for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HEP-Based Early Intervention | Experimental | Participants in this group will receive a hybrid Homeostasis-Environmental Enrichment-Plasticity (HEP®)-based early intervention delivered once weekly in one-hour sessions for 12 weeks. Receives: Behavioral: HEP-Based Early Intervention |
| Conventional Early Intervention | Active comparator | Participants in this group will receive conventional early intervention delivered once weekly in one-hour sessions for 12 weeks. Receives: Behavioral: Conventional Early Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Questionnaire
A 24-item Likert-type questionnaire was developed by the researcher to evaluate the feasibility, acceptability, satisfaction level, and safety of the intervention. The questionnaire items were grouped under four main categories: feasibility (items 1-7), acceptability (items 8-12), satisfaction (items 13-19), and safety (items 20-24). The five-point Likert-type scale included response options ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
Measured: At the end of 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 posted11 Aug 2025
- Study start1 Feb 2026
- Primary completion1 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants at Risk of Cerebral PalsyStudies 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
- This study will use a parallel-group randomized controlled design to compare a hybrid environmental enrichment-based early intervention approach with conventional therapy in infants at risk for cerebral palsy. The experimental group will receive the Homeostasis-Environmental Enrichment-Plasticity (HEP®) Approach, implemented as a hybrid model combining clinic-based and home-based sessions, while the control group will receive conventional early intervention. The HEP approach is an ecological and holistic early intervention model designed to provide multidimensional support to infants at developmental risk during early infancy. It is grounded in the biological foundations of development and the dynamic interaction between the infant and the environment. The intervention framework aims to support physiological homeostasis, promote active environmental exploration, and facilitate neuroplasticity through enriched experiences. Through early and structured environmental enrichment, the HEP
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izgi Miray Demirbag, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116148
- Sponsor's protocol ID
- E-10840098-202.3.02-4232
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach in Infants at Risk of Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07116148
- Acronym / sponsor ID
- E-10840098-202.3.02-4232
- Conditions
- Infants at Risk of Cerebral Palsy
- Keywords
- Environmental enrichment, early intervention, hybrid model, plasticity, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 11 Aug 2025 (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.
This randomized controlled trial aims to evaluate the effects of a hybrid environmental enrichment-based early intervention grounded in the Homeostasis-Enrichment-Plasticity (HEP®) Approach in infants at risk of cerebral palsy (CP). Infants aged 4-10 months identified as being at risk for CP through the Prechtl Assessment or brain imaging will be randomly assigned to either a HEP®-based hybrid environmental enrichment intervention group or a control group receiving conventional intervention. Both groups will receive intervention once weekly for one hour over a 12-week period. Outcomes related to functional goal attainment, developmental performance, and parental well-being will be assessed using the Goal Attainment Scaling (GAS), Bayley Scales of Infant and Toddler Development-III (Bayley-III), Test of Sensory Functions in Infants (TSFI), and Depression Anxiety Stress Scales-21 (DASS-21). Feasibility, safety, and caregiver acceptance of the intervention will also be examined.
Detailed description
This randomized controlled trial is designed to evaluate the effects, feasibility, safety, caregiver acceptability, and satisfaction associated with the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention model grounded in the environmental enrichment (EE) paradigm, in infants at risk of cerebral palsy (CP). In addition to examining the clinical effects of the intervention, the study aims to compare a hybrid HEP®-based environmental enrichment intervention with conventional early intervention approaches.
Infants aged 4-10 months corrected age who are identified as being at risk for CP through the Prechtl Assessment of General Movements or abnormal brain imaging confirmed by a pediatric neurologist will be randomly assigned to either the HEP®-based hybrid environmental enrichment intervention group or a control group receiving conventional intervention. Both groups will receive intervention once weekly for one hour over a 12-week period, ensuring equivalence in intervention dosage while differing in therapeutic content.
The HEP® intervention will be implemented as a hybrid model delivered both in the clinical setting and the home environment, integrating principles of homeostasis, environmental enrichment, and neuroplasticity. The control group will receive conventional early intervention approaches routinely used in clinical practice.
Primary and secondary outcomes will include the achievement of individualized functional goals, developmental performance, and parental well-being. Functional goal attainment will be assessed using the Goal Attainment Scaling (GAS). Developmental outcomes will be evaluated using the Bayley Scales of Infant and Toddler Development-III (Bayley-III) and the Test of Sensory Functions in Infants (TSFI). Parental well-being will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21). In addition, feasibility, safety, caregiver acceptability, and satisfaction related to the intervention will be evaluated using a 24-item Likert-type questionnaire developed by the researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a parallel-group randomized controlled design to compare a hybrid environmental enrichment-based early intervention approach with conventional therapy in infants at risk for cerebral palsy. The experimental group will receive the Homeostasis-Environmental Enrichment-Plasticity (HEP®) Approach, implemented as a hybrid model combining clinic-based and home-based sessions, while the control group will receive conventional early intervention. The HEP approach is an ecological and holistic early intervention model designed to provide multidimensional support to infants at developmental risk during early infancy. It is grounded in the biological foundations of development and the dynamic interaction between the infant and the environment. The intervention framework aims to support physiological homeostasis, promote active environmental exploration, and facilitate neuroplasticity through enriched experiences. Through early and structured environmental enrichment, the HEP
| Arm | Type | Receives |
|---|---|---|
| HEP-Based Early Intervention | Experimental | Behavioral: HEP-Based Early InterventionParticipants in this group will receive a hybrid Homeostasis-Environmental Enrichment-Plasticity (HEP®)-based early intervention delivered once weekly in one-hour sessions for 12 weeks. |
| Conventional Early Intervention | Active comparator | Behavioral: Conventional Early InterventionParticipants in this group will receive conventional early intervention delivered once weekly in one-hour sessions for 12 weeks. |
Who may qualify
- Ages
- 4 to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- According to the general movement assessment, babies from birth to the 8th week have poor repertoire, synchronized cramps or chaotic movement pattern, and the presence of abnormal fidgeting movements between the 6th and 9th weeks.
- A neurologist has detected the presence of abnormal brain imaging on magnetic resonance imaging or cranial ultrasound,
- Absence of congenital anomalies,
- The family agrees to participate regularly in the study.
Key exclusion criteria (4 listed)
- Major vision or hearing problems,
- Presence of any genetic syndrome or congenital anomaly,
- Medical conditions that prevent active participation in the study (such as oxygen dependence),
- Participation 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-Based Early InterventionHEP-Based Early Intervention The Homeostasis-Environmental Enrichment-Plasticity (HEP®) Approach is an ecological and holistic early intervention model based on the environmental enrichment paradigm. The intervention is designed to support infants at developmental risk by promoting physiological homeostasis, encouraging active environmental exploration, and facilitating neuroplasticity through enriched and meaningful experiences. In this study, the HEP approach will be implemented as a hybrid model combining clinic-based and home-based sessions. Intervention content will be individualized according to the infant's developmental needs and functional goals. | Behavioural | HEP-Based Early Intervention |
| Conventional Early InterventionConventional early intervention will be delivered based on standard therapy practices commonly used in early intervention programs. The intervention will include a range of techniques aimed at improving muscle strength and supporting postural control. Therapeutic handling techniques will be applied by the therapist to prevent maladaptive movement patterns and to facilitate appropriate and functional movement responses. The intervention will be provided once weekly in one-hour sessions for 12 weeks. | Behavioural | Conventional Early Intervention |
Primary outcome
Feasibility Questionnaire
Time frame: At the end of the 12-week intervention
A 24-item Likert-type questionnaire was developed by the researcher to evaluate the feasibility, acceptability, satisfaction level, and safety of the intervention. The questionnaire items were grouped under four main categories: feasibility (items 1-7), acceptability (items 8-12), satisfaction (items 13-19), and safety (items 20-24). The five-point Likert-type scale included response options ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
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 30 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEP-Based Early Intervention and Conventional Early Intervention in people with Infants at Risk of Cerebral Palsy, run by Medipol University at 2 sites 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 5 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Feasibility Questionnaire (time frame: At the end of the 12-week intervention). 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 30 Sep 2026.