Recruiting

Observational StudyIntensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

Sponsor:

Healing Hope International

Code:

NCT07493096

Conditions

Neurodevelopmental Disorders

Neurodevelopmental Disorders (NDD)

Neurodevelopmental Disorders and Developmental Abnormalities

Developmental Delay (Disorder)

Cerebral Palsy (CP)

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Study Details

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

Neurodevelopmental Disorders (NDD)

Neurodevelopmental Disorders and Developmental Abnormalities

Developmental Delay (Disorder)

Cerebral Palsy (CP)

Study ID

NCT07493096

Start date

Mar 1, 2026

Status verified date

Mar, 2026

Completion date

Dec 30, 2036

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Genelle Mills, OTR/L

(480) 620-4514 genelle@abilityandbeyond.com

Tamara Tamas, MS RA

(863) 354- 5131

Locations

Ability and Beyond

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

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

936-271-1337 tina@abilityandbeyond.com

More Information

Sponsor

Healing Hope International

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Healing Hope International on 2026-03-25.