The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Peabody Developmental Motor Scales-2 (PDMS-2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Peabody Developmental Motor Scales-2 (PDMS-2)
时间窗: 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.
次要结局
- Test of Sensory Functions in Infants (TSFI)(Pre-intervention and 12-week post-intervention.)
- The Ages and Stages Questionnaires (ASQ)(Pre-intervention and 12-week post-intervention.)
研究者
Izgi Miray Demirbag
Physiotherapist
Medipol University