Trials / Recruiting

RecruitingNCT07493096

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

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

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 100 (estimated)

Sponsor: Healing Hope International · Academic / Other
Sex: All
Age: 4 Years – 12 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date: 2026-03-01
Primary completion: 2028-01-01
Completion: 2036-12-30
First posted: 2026-03-25
Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07493096. Inclusion in this directory is not an endorsement.