Two-week intensive brain-focused therapy program for children with neurodevelopmental and chromosomal conditions

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

This program will try a two-week, individualized multimodal neurorehabilitation approach for children about 4–12 years old with neurodevelopmental or chromosomal conditions to see if it improves attention, motor skills, communication, and daily functioning.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 4 Years to 12 Years
• Sex: All
• Sponsor: Healing Hope International (Academic / other)
• Locations: 1 site (The Woodlands, Texas)
• Trial ID: NCT07493096 on ClinicalTrials.gov

What this trial studies

This is a prospective observational characterization of outcomes for pediatric participants enrolled in a two-week intensive multimodal neurorehabilitation program. Children attend approximately 2.5 hours per day, five days per week, for two consecutive weeks, receiving individualized combinations of therapies such as sensory integration, motor planning, reflex integration, oculomotor training, executive function activities, communication supports, and adjunctive modalities. No randomization or experimental intervention is introduced; all therapies are delivered as part of routine clinical care and tailored to each child. Clinical and caregiver-reported measures are collected before and after the program to document functional and developmental changes.

Who should consider this trial

Good fit: Ideal candidates are children approximately 4–12 years old with neurodevelopmental, neurologic, or genetic/chromosomal diagnoses who have measurable functional impairments and can attend an in-person two-week intensive therapy schedule.

Not a fit: Children outside the age range, those who cannot tolerate or attend intensive in-person therapy (for example due to medical instability, uncontrolled seizures, or severe behavioral challenges), or those without target functional impairments are less likely to benefit.

Why it matters

Potential benefit: If successful, the program could improve attention, motor coordination, communication, emotional regulation, and day-to-day independence for participating children.

How similar studies have performed: Previous research on high-frequency, intensive pediatric neurorehabilitation (particularly motor-focused programs) has shown promising but mixed results, while evidence for adjunctive modalities like photobiomodulation and vibration therapy remains limited.

Eligibility criteria

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.

Where this trial is running

The Woodlands, Texas

• Ability and Beyond — The Woodlands, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP — Board Certified Pediatric Therapist Executive Director Ability and Beyond Integrated Therapies
• Study coordinator: Genelle Mills, OTR/L

Conditions Neurodevelopmental Disorders; Neurodevelopmental Disorders and Developmental Abnormalities; Developmental Delay; Cerebral Palsy; Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment; Cerebral Palsy Infantile; Cerebral Palsy Spastic Hemiplegic; Cerebral Palsy, Dyskinetic