Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Clinician Assessed Functional Neurodevelopmental Performance
研究概览
简要总结
This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.
Participants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.
The purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.
This study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.
详细描述
Children with neurodevelopmental disorders often present with complex impairments affecting motor function, sensory processing, communication, attention, emotional regulation, and daily living skills. These conditions may arise from acquired neurologic injury (such as hypoxic ischemic encephalopathy or traumatic brain injury) or from genetic and chromosomal abnormalities (such as Down syndrome, Rett syndrome, or other genomic disorders).
Traditional therapy models delivered at low frequency may not fully address the intensity required to drive meaningful neuroplastic change. Intensive, high frequency, and multimodal rehabilitation approaches have been proposed as a strategy to enhance neural adaptation by increasing repetition, engagement, and cross-modal stimulation within a short time period.
This observational study is designed to systematically characterize real world outcomes associated with a two week pediatric intensive therapy model that integrates multiple therapeutic modalities tailored to the individual child.
This is a prospective observational study of pediatric participants enrolled in an intensive therapy program. No randomization or experimental intervention is introduced as part of the study. All therapies are delivered as part of routine clinical care.
Participants attend therapy sessions for approximately 2.5 hours per day, 5 days per week, for 2 consecutive weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.
- •Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:
- •cerebral palsy
- •autism spectrum disorder
- •developmental delay
- •hypoxic ischemic encephalopathy (HIE)
- •traumatic brain injury
- •sensory processing disorder
- •chromosomal or genetic abnormalities
- •Demonstrate functional impairments in one or more neurodevelopmental domains, including:
- •motor coordination or motor planning
- •sensory processing
- •attention or executive functioning
- •oculomotor or visual processing
- •communication
- •emotional or behavioral regulation
- •activities of daily living
- •Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day/ 5 days per week
- •Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.
- •Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.
排除标准
- •Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.
- •Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.
- •Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.
- •Inability to attend or complete the full two-week intensive program.
- •Lack of sufficient baseline or post-intervention data to assess change in functional performance.
- •Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.
结局指标
主要结局
Change in Clinician Assessed Functional Neurodevelopmental Performance
时间窗: Baseline to end of 2 week intensive program
Within participant change from baseline to completion of the 2 week intensive program in individualized clinician assessed neurodevelopmental performance domains used in routine care. Measures may include neural timing accuracy in milliseconds relative to metronome paced motor tasks, oculomotor performance scored by saccadic eye movements and horizontal pursuits, primitive reflex integration scored on a 0-5 scale, processing speed/visual scanning completion time, bilateral coordination, crossing midline, sustained attention duration, tactile or stimulation tolerance, executive functioning, emotional regulation, communication intent, and participation in non preferred activities. Each participant is assessed only on domains relevant to their presentation, consistent with the source document's individualized assessment model.
次要结局
- Change in Neural Timing Accuracy(Baseline to end of 2 week intensive program)
- Change in Oculomotor Control(Baseline to end of 2 week intensive program)
- Change in Primitive Reflex Persistence(Baseline to end of 2 week intensive program)
- Change in Processing Speed and Visual Scanning Time(Baseline to end of 2-week intensive program)
- Change in Bilateral Word Taps and Cross Midline Performance(Baseline to end of 2-week intensive program)
- Change in Attention, Activity Tolerance, and Participation in Non Preferred Activities(Baseline to end of 2 week intensive program)
- Change in Emotional Self Regulation(Baseline to end of 2 week intensive program)
- Parent Reported Functional Carryover and Retention of Gains(Up to 4 weeks after completion of the intensive program)