The Effect of the HEP Approach in Infants With Down Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEP Intervention, Traditional Therapy.
- Who it may be relevant to
- Registry conditions: Down Syndrome (DS). Basic parameters: 4 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome
Overview
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.
Interventions
- Behavioral HEP Intervention
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, - Behavioral Traditional Therapy
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.
Primary outcome measures
- Peabody Developmental Motor Scales-2 (PDMS-2) [Time frame: Pre-intervention and 12-week post-intervention.]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Sense On — Istanbul
Identifiers
NCT: NCT07163780 · E-10840098-202.3.02-2211