The Effect of the HEP Approach in Infants With Down Syndrome (HEP-DS)

Izgi Miray Demirbag

Status: Enrolling

Conditions: Down Syndrome (DS)

Treatments: Behavioral: HEP Intervention; Behavioral: Traditional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07163780

E-10840098-202.3.02-2211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 4 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

HEP Intervention

Experimental group

Description:

Participants will receive 12 sessions of HEP therapy, once per week, 45 minutes each.

Treatment:

Behavioral: HEP Intervention

Traditional Therapy

Active Comparator group

Description:

Participants will receive 12 sessions of traditional therapy, once per week, 45 minutes each.

Treatment:

Behavioral: Traditional Therapy