Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gross Motor Skills
研究概览
简要总结
INTRODUCTION: This project is presented as a continuation of the one approved in 2019 (Code: UALBIO2019/013). Early Intervention is defined as all interventions, including prevention, carried out with children aged 0-6 years, their families, and their environment, in order to respond to what each child needs to advance in their development as early as possible.
Psychomotor Delay indicates a slow developmental trajectory in several areas. Premature infants frequently face a potential psychomotor delay, usually due to the immaturity associated with being born earlier than expected. Children born preterm account for 50% of functional diversity in the pediatric population, presenting sequelae in the perinatal period, in the short term, and in the long term. In a previous study conducted by our group, the importance of early follow-up and treatment for children born very preterm was demonstrated.
Neurodevelopmental disorders with motor impairments in children require physiotherapy treatment from the time of diagnosis, throughout early childhood intervention, and across the lifespan. The most prevalent condition is cerebral palsy, which is the leading cause of childhood disability. Its prevalence ranges from 1.5 to 3.0 per 1,000 live births, with no major changes observed in adolescent and adult populations, and with higher occurrence in males than females. Other important conditions due to their frequency and symptoms include congenital malformations and syndromes.
OBJECTIVE: To analyze the effects of advanced physiotherapy programs on development, activity, and participation in children receiving early intervention and presenting motor disorders.
METHODOLOGY: Clinical trial with experimental groups and one control group. Advanced physiotherapy programs based on evidence will be studied, carried out with and involving the family, and supported by specialized care.
The sample will be obtained from centers and associations collaborating with the University of Almería. Before conducting the study, informed consent will be requested from parents or legal guardians. Baseline assessments and follow-up measurements will be performed. Validated and relevant variables related to development and motor difficulties will be used. The data obtained during the project will be stored in a database.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature infants with a gestational age between 24 and 32 weeks, with an adequate weight for their gestational age
排除标准
- •Neurological disorders
- •Invasive mechanical ventilation
- •Congenital disorders
- •Necrotising enterocolitis
- •Metabolic diseases
- •Intraventricular hemorrhage grade 3-4
- •Genetic disorders
- •Oral disorders that make this process difficult(cleft palate, cleft lip...)
- •Serious illnesses according to medical criteria
研究组 & 干预措施
NoTreat-NO-BOB
干预措施: Ordinary care (Other)
TreatBOB
干预措施: Bobath (Other)
TreatNO-BOB
干预措施: Early Intervention (Other)
结局指标
主要结局
Gross Motor Skills
时间窗: 2 Years
To evaluate the baby's gross motor competence during early motor development, the investigators will employ the Alberta Infant Motor Scale (AIMS). This tool, developed by Canadian researchers, is an observational assessment designed for infants from birth until they achieve independent walking. It includes 58 items that examine antigravity muscle control and overall motor performance across four positions: prone, supine, sitting, and standing (de Albuquerque et al., 2015). This tool provides percentile scores (0-100) for gross motor developmental, with higher scores indicating more advanced abilities.
Neuromotor Development
时间窗: 2 Years
To evaluate motor, cognitive, and language development, the investigators will use the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), one of the most widely applied instruments for assessing early development. Its primary purpose is to identify children who may present developmental delays and to guide the planning of appropriate interventions. The Bayley-III consists of six subscales that measure cognitive, language, motor, social-emotional, adaptive, and behavioral skills in children aged 1 to 42 months (de Albuquerque et al., 2018). This tool provides percentile scores (0-100) for each developmental domain, with higher scores indicating more advanced abilities.
Gross Motor Skills
时间窗: 2 Years
To evaluate the baby's gross motor competence during early motor development, the investigators will employ the Alberta Infant Motor Scale (AIMS). This tool, developed by Canadian researchers, is an observational assessment designed for infants from birth until they achieve independent walking. It includes 58 items that examine antigravity muscle control and overall motor performance across four positions: prone, supine, sitting, and standing (de Albuquerque et al., 2015). This tool provides percentile scores (0-100) for gross motor developmental, with higher scores indicating more advanced abilities.
Neuromotor Development
时间窗: 2 Years
To evaluate motor, cognitive, and language development, the investigators will use the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), one of the most widely applied instruments for assessing early development. Its primary purpose is to identify children who may present developmental delays and to guide the planning of appropriate interventions. The Bayley-III consists of six subscales that measure cognitive, language, motor, social-emotional, adaptive, and behavioral skills in children aged 1 to 42 months (de Albuquerque et al., 2018). This tool provides percentile scores (0-100) for each developmental domain, with higher scores indicating more advanced abilities.
次要结局
- Parents Experiences about Development(2 Years)
- Parents Experiences about Development(2 Years)
研究者
María del Mar Sánchez Joya
Phd Doctor
Universidad de Almeria