Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

Официальное название

Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities

Обзор

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.

Подробное описание

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.

Therapy is individualized and may include a combination of:

* Sensory integration techniques * Motor planning and coordination activities * Reflex integration exercises * Oculomotor and visual processing training * Auditory processing activities * Executive functioning tasks * Communication support strategies * Emotional regulation training * Brain based and neurodevelopmental exercises

Additional modalities such as vibration, tactile stimulation, and photobiomodulation may be used at the discretion of the treating clinician.

This study aims to generate real world evidence on the potential benefits of intensive, individualized, multimodal neurorehabilitation in children with complex neurodevelopmental conditions, including those with genetic and chromosomal etiologies. Findings may inform future controlled studies and help guide clinical decision making for therapy intensity and program design.

Первичные конечные точки

• Change in Clinician Assessed Functional Neurodevelopmental Performance [Срок оценки: Baseline to end of 2 week intensive program]

Вторичные конечные точки (8)

• Change in Neural Timing Accuracy [Срок оценки: Baseline to end of 2 week intensive program]
• Change in Oculomotor Control [Срок оценки: Baseline to end of 2 week intensive program]
• Change in Primitive Reflex Persistence [Срок оценки: Baseline to end of 2 week intensive program]
• Change in Processing Speed and Visual Scanning Time [Срок оценки: Baseline to end of 2-week intensive program]
• Change in Bilateral Word Taps and Cross Midline Performance [Срок оценки: Baseline to end of 2-week intensive program]
• Change in Attention, Activity Tolerance, and Participation in Non Preferred Activities [Срок оценки: Baseline to end of 2 week intensive program]
• Change in Emotional Self Regulation [Срок оценки: Baseline to end of 2 week intensive program]
• Parent Reported Functional Carryover and Retention of Gains [Срок оценки: Up to 4 weeks after completion of the intensive program]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Ability and Beyond — The Woodlands

Публикации

• Ward, R., Reynolds, J., & Marshall, A. (2019). Intensity of therapy and functional outcomes in children receiving rehabilitation: A systematic review. Developmental Medicine & Child Neurology, 61(8), 906-915. https://doi.org/10.1111/dmcn.14190
• Sakzewski L, Ziviani J, Boyd RN. Delivering evidence-based upper limb rehabilitation for children with cerebral palsy: barriers and enablers identified by three pediatric teams. Phys Occup Ther Pediatr. 2014 Nov;34(4):368-83. doi: 10.3109/01942638.2013.861890. Epub 2013 Dec 4. PMID 24303800
• Novak I, Honan I. Effectiveness of paediatric occupational therapy for children with disabilities: A systematic review. Aust Occup Ther J. 2019 Jun;66(3):258-273. doi: 10.1111/1440-1630.12573. Epub 2019 Apr 10. PMID 30968419
• Bower, E., McLellan, D. L., Arney, J., & Campbell, M. J. (1996). A randomized controlled trial of different intensities of physiotherapy and constraint-induced movement therapy in children with cerebral palsy. BMJ, 312(7033), 1239-1243. https://doi.org/10.1136/bmj.312.7033.1239

Идентификаторы

NCT: NCT07493096 · HHI-ND-OBS-2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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