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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Ability and Beyond
RECRUITING
The Woodlands
Contact Information
Primary
Genelle Mills, OTR/L
genelle@abilityandbeyond.com
(480) 620-4514
Backup
Tamara Tamas, MS RA
(863) 354- 5131
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2036-12-30
Participants
Target number of participants: 100
Treatments
Pediatric Intensive Multimodal Neurorehabilitation Cohort
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.
Sponsors
Leads: Healing Hope International

This content was sourced from clinicaltrials.gov