Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders (GEN-HOPE)

Healing Hope International

Status: Enrolling

Conditions: Sensory Processing Disorder; Cerebral Palsy Spastic Hemiplegic; Neurodevelopmental Disorders (NDD); Autism Spectrum Disorder; Cerebral Palsy, Dyskinetic; Down Syndrome (Trisomy 21); RETT Syndrome With Proven MECP2 Mutation; Neurodevelopmental Disorders; Hypoxic Ischemic Encephalopathy (HIE); Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment; Traumatic Brain Injury (TBI); Genetic Disorders; Chromosomal Abnormalities; Fragile X Syndrome (FXS); Cerebral Palsy Infantile; Hypoxic Ischemic Encephalopathy; Developmental Delay (Disorder); Neurodevelopmental Disorders and Developmental Abnormalities; Williams Syndrome; Sensorimotor Integration; Autism Spectrum Disorder (ASD; Cerebral Palsy (CP); 22q11.2 Deletion Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT07493096

HHI-ND-OBS-2025-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

100 participants in 1 patient group

Pediatric Intensive Multimodal Neurorehabilitation Cohort

Description:

This cohort includes pediatric participants with neurodevelopmental disorders, including cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy, traumatic brain injury, and genetic or chromosomal abnormalities, who are enrolled in a two-week intensive multimodal neurorehabilitation program. Participants receive individualized therapy for approximately 2.5 hours per day, 5 days per week, for 2 consecutive weeks. The intervention is not standardized and is tailored to each participant's clinical needs. Therapy may include sensory integration, motor planning, reflex integration, oculomotor training, auditory processing activities, executive functioning tasks, communication support, emotional regulation strategies, and other neurodevelopmental approaches. Additional modalities such as tactile stimulation, vibration, and photobiomodulation may be utilized at the discretion of the treating clinician.