Effects of Telematic Support in Physical Therapy Early Intervention on Infants At Risk of Neurodevelopmental Delays and Disorders
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.
研究概览
简要总结
The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.
详细描述
The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
- •At risk of neurodevelopmental delays or disorders.
- •Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.
排除标准
- •Independent walking children.
- •Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
- •Infants with orthoses and/or prostheses.
- •Children with health complications that enable the child's participation in the study.
- •Not spanish-speaking parents.
结局指标
主要结局
Change from Baseline in Motor Development on the Motor scale of the Infant Motor Development on the Bayley Scales of Infant and Toddler Development-III® (BSID-III) at month 2.
时间窗: Baseline and Month 2.
The BSID-III is an assessment tool for diagnosing developmental delays in early childhood from 1 to 42 months. It assesses 5 developmental domains: Cognitive Scale, Language Scale, Motor scale, Social-Emotional Scale and Adaptative Scale. The motor scale has 66 items in the fine motor and 72 items in the gross motor domain which are administrated according to the child development. Change= (2 months development score - baseline Score).
Change from Baseline in maturation of motor skills on the Alberta Infant Motor Scale (AIMS) at month 2.
时间窗: Baseline and Month 2.
The AIMS is an observational assessment tool that requires minimal handling of an infant by the examiner. It assesses the maturation of infant's motor skills from term (40 weeks gestation) to 18 months. It has 58 observational items divided into four subscales which are prone, supine, sitting and standing. Change= (2 months development score - baseline Score).
Change from Baseline in infant motor behaviour and motor development on the Infant Motor Profile (IMP) at month 2.
时间窗: Baseline and Month 2.
The IMP is a video-based assessment for infants aged 3 to 18 months. It assesses the spontaneous motor behaviour in supine, prone, sitting, standing, walking and during reaching and grasping - depending on the age of the infant. Includes 5 domains: the size of the infant's motor repertoire, the infant's ability to make an adaptive selection out of his/her repertoire, performance, symmetry and fluency. Change= (2 months IMP total and subscales scores - baseline scores).
次要结局
- Change from Baseline in parents' quality of life on the Care-related quality of life (CarerQol) at month 2.(Baseline and Month 2.)
- Change from Baseline in levels of stress experienced by parents on the Parental Stress Scale (PSS) at month 2.(Baseline and Month 2.)
- Parents satisfaction with the telematic support service measured with the Client Satisfaction Questionnaire (CSQ-8).(Month 2)
- Change from Baseline in parental self-efficacy and satisfaction of being a parent on the Parenting Sense of Competence (PSOC) at month 2.(Baseline and Month 2.)
研究者
Marie Carmen Valenza
PT, PhD, Professor at University of Granada
Universidad de Granada