Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

Part of paid clinical trials in The Woodlands, Texas.

Sponsor
Healing Hope International
Study ID
NCT07493096
Status
Recruiting

Conditions

  • 22q11.2 Deletion Syndrome
  • Autism Spectrum Disorder
  • Autism Spectrum Disorder (ASD
  • 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
  • Chromosomal Abnormalities
  • Developmental Delay (Disorder)
  • Down Syndrome (Trisomy 21)
  • Fragile X Syndrome (FXS)
  • Genetic Disorders
  • Hypoxic Ischemic Encephalopathy
  • Hypoxic Ischemic Encephalopathy (HIE)
  • Neurodevelopmental Disorders
  • Neurodevelopmental Disorders (NDD)
  • Neurodevelopmental Disorders and Developmental Abnormalities
  • RETT Syndrome With Proven MECP2 Mutation
  • Sensorimotor Integration
  • Sensory Processing Disorder
  • Traumatic Brain Injury (TBI)
  • Williams Syndrome

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Dec 30, 2036

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Clinician Assessed Functional Neurodevelopmental Performance [ Time Frame: Baseline to end of 2 week intensive program ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ability and BeyondThe WoodlandsTexas77380
Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP
936-271-1337

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