Down Syndrome (DS)HEP-DSNCT07163780
The Effect of the HEP Approach in Infants With Down Syndrome
A study testing HEP Intervention and Traditional Therapy in people with Down Syndrome (DS), run by Izgi Miray Demirbag at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests. Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Down Syndrome (DS)
- What is being tested?
- HEP Intervention and Traditional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2025to 3 Dec 2025
- 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
- Must be between 4 and 12 months old
- Must have been diagnosed with Down Syndrome
- Must not be at any neurological risk
- Parent must agree to participate regularly in the study process
Who cannot join
- History of intraventricular hemorrhage (Grade III or IV)
- Major vision or hearing impairment
- History of febrile convulsion
- Medical conditions (e.g., oxygen dependence) that prevent active participation in the study
- Participation in other experimental rehabilitation studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sense On
Istanbul, Beykoz, 34810
Aymen Balıkcı, Dr. Physiotherapist, 05069328294, izgimiray@hotmail.com
Aymen Cagla Sırma, Dr. Physiotherapist, +905454470067, izgimiray@hotmail.com
About this study
Official title: The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome
This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.
Read the detailed description
This clinical study will be conducted at a private clinic in Istanbul and will enroll 26 infants with Down syndrome who meet the inclusion criteria. Participants will be recruited through social media and referrals from professionals who follow infants with Down syndrome.
Written informed consent will be obtained from parents after explaining the study's purpose, duration, assessments, and interventions. Demographic, perinatal, natal, and postnatal data will be collected via a "Demographic Information Form." Gross and fine motor skills will be evaluated with Peabody Developmental Motor Scales-2 (PDMS-2), sensory functions with the Infant Sensory Function Test (BDFT), and parents will complete the The Ages and Stages Questionnaires (ASQ) to assess multiple developmental domains. Individual goals will be set using the Goal Attainment Scale (GAS), and social validity will be assessed post-intervention via a parent questionnaire.
The intervention group will receive 12 sessions (once a week, 45 minutes each) of HEP therapy, delivered by a physiotherapist experienced in the HEP approach. The control group will receive 12 sessions of traditional therapy administered by an experienced pediatric rehabilitation physiotherapist.
- Conditions
- Down Syndrome (DS)
- Being tested
- HEP Intervention, Traditional Therapy
- Keywords
- Down Syndrome, Infants, Early Intervention, Neuroplasticity, Environmental Enrichment
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEP InterventionBehavioural
This intervention is administered to the HEP Intervention arm.
The HEP approach, which includes intervention, is a child-centered, family-based early intervention approach based on the principles of enriched environment and plasticity, emphasizing the importance of homeostasis. It is based on theories that argue that development occurs as a result of the dynamic interaction between the environment, time, task, and individual (Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model). Hypotheses for intervention are generated based on a comprehensive assessment of these four fundamental factors (environment, time, task, and individual), and 10 core principles derived from environmental enrichment studies are applied with the guidance of ecological models.
Traditional TherapyBehavioural
Participants in this arm will receive conventional pediatric therapy, consisting of 12 weekly sessions of 45 minutes each. Sessions will focus on standard motor and sensory development exercises, delivered by a physical therapist experienced in pediatric rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| HEP Intervention | Experimental | Participants will receive 12 sessions of HEP therapy, once per week, 45 minutes each. Receives: Behavioral: HEP Intervention |
| Traditional Therapy | Active comparator | Participants will receive 12 sessions of traditional therapy, once per week, 45 minutes each. Receives: Behavioral: Traditional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scales-2 (PDMS-2)
The PDMS-2 is a scale used to identify motor developmental delays in children aged 0-6 and to determine motor skill levels and individual needs.
The PDMS-2 consists of two main sections: gross motor and fine motor, and 249 items. The gross motor section consists of reflexes, balance, locomotion, and object manipulation, while the fine motor section consists of comprehension and visual-motor integration. A score of 2 is given if the child's performance is within the desired level, 1 if it is similar to the desired level, and 0 if it is not.
To determine the risk and level of developmental delay, gross motor skills, fine motor skills, and general motor development are categorized as "very low, low, below average, average, above average, high, and very high," using age-appropriate normative ranges in the test manual.
Measured: Pre-intervention and 12-week post-intervention.
Secondary outcomes (2)
Test of Sensory Functions in Infants (TSFI)
Developed to assess sensory responsiveness, this test consists of five subsections and 24 items, and takes 20 minutes to administer. The test subsections include tactile deep pressure response, adaptive motor functions, visual-tactile integration, oculomotor control, and vestibular stimulus response.
This test is suitable for evaluating at-risk groups for sensory processing disorders, such as infants with developmental delays. Based on their score, the infant is assessed as normal, at-risk, or impaired in terms of sensory processing. A higher score indicates better sensory processing.
Measured: Pre-intervention and 12-week post-intervention.
The Ages and Stages Questionnaires (ASQ)
The ASQ is a developmental screening test that allows parents to assess a child's development. The questionnaires consist of three sections: demographic questions, a 30-question section about the child's development, and seven open-ended questions. The 30 questions addressing the child's development cover the areas of communication, fine motor development, gross motor development, problem-solving, and personal and social development, with each section consisting of six questions.
Measured: Pre-intervention and 12-week post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start3 Sep 2025
- Primary completion3 Dec 2025 (estimated)
- Study completion3 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome (DS)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study includes two groups: one group will receive the HEP intervention, and the other group will receive traditional therapy.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
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
- NCT07163780
- Sponsor's protocol ID
- E-10840098-202.3.02-2211
- Acronym
- HEP-DS
- Status last verified
- Nov 2025
- First submitted
- 1 Sep 2025
- Last updated
- 14 Nov 2025
- 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 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT07163780
- Acronym / sponsor ID
- HEP-DS / E-10840098-202.3.02-2211
- Conditions
- Down Syndrome (DS)
- Keywords
- Down Syndrome, Infants, Early Intervention, Neuroplasticity, Environmental Enrichment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Izgi Miray DemirbagUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 3 Dec 2025 (estimated)
- Study completion
- 3 Dec 2025 (estimated)
- First posted
- 9 Sep 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 study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.
Detailed description
This clinical study will be conducted at a private clinic in Istanbul and will enroll 26 infants with Down syndrome who meet the inclusion criteria. Participants will be recruited through social media and referrals from professionals who follow infants with Down syndrome.
Written informed consent will be obtained from parents after explaining the study's purpose, duration, assessments, and interventions. Demographic, perinatal, natal, and postnatal data will be collected via a "Demographic Information Form." Gross and fine motor skills will be evaluated with Peabody Developmental Motor Scales-2 (PDMS-2), sensory functions with the Infant Sensory Function Test (BDFT), and parents will complete the The Ages and Stages Questionnaires (ASQ) to assess multiple developmental domains. Individual goals will be set using the Goal Attainment Scale (GAS), and social validity will be assessed post-intervention via a parent questionnaire.
The intervention group will receive 12 sessions (once a week, 45 minutes each) of HEP therapy, delivered by a physiotherapist experienced in the HEP approach. The control group will receive 12 sessions of traditional therapy administered by an experienced pediatric rehabilitation physiotherapist.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study includes two groups: one group will receive the HEP intervention, and the other group will receive traditional therapy.
| Arm | Type | Receives |
|---|---|---|
| HEP Intervention | Experimental | Behavioral: HEP InterventionParticipants will receive 12 sessions of HEP therapy, once per week, 45 minutes each. |
| Traditional Therapy | Active comparator | Behavioral: Traditional TherapyParticipants will receive 12 sessions of traditional therapy, once per week, 45 minutes each. |
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Must be between 4 and 12 months old
- Must have been diagnosed with Down Syndrome
- Must not be at any neurological risk
- Parent must agree to participate regularly in the study process
Key exclusion criteria (5 listed)
- History of intraventricular hemorrhage (Grade III or IV)
- Major vision or hearing impairment
- History of febrile convulsion
- Medical conditions (e.g., oxygen dependence) that prevent active participation in the study
- 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 InterventionThis intervention is administered to the HEP Intervention arm. The HEP approach, which includes intervention, is a child-centered, family-based early intervention approach based on the principles of enriched environment and plasticity, emphasizing the importance of homeostasis. It is based on theories that argue that development occurs as a result of the dynamic interaction between the environment, time, task, and individual (Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model). Hypotheses for intervention are generated based on a comprehensive assessment of these four fundamental factors (environment, time, task, and individual), and 10 core principles derived from environmental enrichment studies are applied with the guidance of ecological models. | Behavioural | HEP Intervention |
| Traditional TherapyParticipants in this arm will receive conventional pediatric therapy, consisting of 12 weekly sessions of 45 minutes each. Sessions will focus on standard motor and sensory development exercises, delivered by a physical therapist experienced in pediatric rehabilitation. | Behavioural | Traditional Therapy |
Primary outcome
Peabody Developmental Motor Scales-2 (PDMS-2)
Time frame: Pre-intervention and 12-week post-intervention.
The PDMS-2 is a scale used to identify motor developmental delays in children aged 0-6 and to determine motor skill levels and individual needs. The PDMS-2 consists of two main sections: gross motor and fine motor, and 249 items. The gross motor section consists of reflexes, balance, locomotion, and object manipulation, while the fine motor section consists of comprehension and visual-motor integration. A score of 2 is given if the child's performance is within the desired level, 1 if it is similar to the desired level, and 0 if it is not. To determine the risk and level of developmental delay, gross motor skills, fine motor skills, and general motor development are categorized as "very low, low, below average, average, above average, high, and very high," using age-appropriate normative ranges in the test manual.
2 secondary outcomes
Test of Sensory Functions in Infants (TSFI)
Time frame: Pre-intervention and 12-week post-intervention.
The Ages and Stages Questionnaires (ASQ)
Time frame: Pre-intervention and 12-week post-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 14 Nov 2025.
- 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.
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 Intervention and Traditional Therapy in people with Down Syndrome (DS), 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 5 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. 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?
Contact İzgi Miray Demirbağ, Physiotherapist (+905516626550, izgimiray@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales-2 (PDMS-2) (time frame: Pre-intervention and 12-week post-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 14 Nov 2025.