Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

NCT07493096 | Recruiting

• 1 other identifier: HHI-ND-OBS-2025-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Photobiomodulation; Low-Level Laser Therapy; Vibration Therapy; Tactile Stimulation; Cognitive Training; Behavioral Therapy; Intensive Therapy; Pediatric Neurorehabilitation; Multimodal Therapy; Neuroplasticity; Sensory Integration; Reflex Integration; Motor Planning; Executive Function; Emotional Regulation; Functional Outcomes; Activities of Daily Living; High Frequency Therapy; Neurodevelopmental Disorders; Rehabilitation; Child Development Disorders; Occupational Therapy; Physical Therapy Modalities; Early Intervention; Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Clinician Assessed Functional Neurodevelopmental Performance

  Within participant change from baseline to completion of the 2 week intensive program in individualized clinician assessed neurodevelopmental performance domains used in routine care. Measures may include neural timing accuracy in milliseconds relative to metronome paced motor tasks, oculomotor performance scored by saccadic eye movements and horizontal pursuits, primitive reflex integration scored on a 0-5 scale, processing speed/visual scanning completion time, bilateral coordination, crossing midline, sustained attention duration, tactile or stimulation tolerance, executive functioning, emotional regulation, communication intent, and participation in non preferred activities. Each participant is assessed only on domains relevant to their presentation, consistent with the source document's individualized assessment model.

  Baseline to end of 2 week intensive program

Secondary Outcomes (8)

• Change in Neural Timing Accuracy

  Baseline to end of 2 week intensive program

• Change in Oculomotor Control

  Baseline to end of 2 week intensive program

• Change in Primitive Reflex Persistence

  Baseline to end of 2 week intensive program

• Change in Processing Speed and Visual Scanning Time

  Baseline to end of 2-week intensive program

• Change in Bilateral Word Taps and Cross Midline Performance

  Baseline to end of 2-week intensive program

Study Arms (1)

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.

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pediatric participants enrolled in a two week intensive therapy program conducted in a clinical pediatric neurodevelopmental rehabilitation setting. Participants are drawn from a real world clinical population referred for intensive therapy due to functional impairments in motor, sensory, cognitive, communication, and/or regulatory domains. Participants represent a heterogeneous group of children with neurodevelopmental, neurologic, and genetic conditions, including those with acquired brain injury, developmental disorders, and chromosomal abnormalities. Children are referred through clinical providers or caregiver self referral and participate as part of routine care rather than assignment to a research intervention. This population reflects a community based sample of children receiving individualized, high frequency, multimodal therapy in an outpatient intensive program.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healing Hope International: lead

Study Sites (1)

Ability and Beyond

The Woodlands, Texas, 77380, United States

RECRUITING

Related Publications (4)

• 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

  BACKGROUND

• Sakzewski, L., Ziviani, J., & Boyd, R. N. (2014). Delivering evidence-based upper limb rehabilitation for children with cerebral palsy: Barriers and enablers identified by three pediatric teams. Physical & Occupational Therapy in Pediatrics, 34(4), 368-383. https://doi.org/10.3109/01942638.2014.918111

  BACKGROUND

• Novak, I., & Honan, I. (2019). Effectiveness of paediatric occupational therapy for children with disabilities: A systematic review. Australian Occupational Therapy Journal, 66(3), 258-273. https://doi.org/10.1111/1440-1630.12573

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Developmental Disabilities; Cerebral Palsy; Autism Spectrum Disorder; Hypoxia-Ischemia, Brain; Brain Injuries, Traumatic; Chromosome Aberrations; Genetic Diseases, Inborn; Down Syndrome; Fragile X Syndrome; Williams Syndrome; DiGeorge Syndrome; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Child Development Disorders, Pervasive; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; X-Linked Intellectual Disability; Sex Chromosome Disorders; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System; Aortic Stenosis, Supravalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; 22q11 Deletion Syndrome; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Self-Control; Social Behavior; Behavior

Study Officials

• Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP

  Board Certified Pediatric Therapist Executive Director Ability and Beyond Integrated Therapies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Genelle Mills, OTR/L

CONTACT

(480) 620-4514; genelle@abilityandbeyond.com

Tamara Tamas, MS RA

CONTACT

(863) 354- 5131

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 30, 2036
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)