ClinicalTrials.gov record NCT07493096

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age4 years old to 12 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects clinical data on children with neurodevelopmental or chromosomal disorders who attend a two-week intensive multimodal therapy program. Therapy is individualized and typically about 2.5 hours per day, 5 days per week. The study records clinician-observed and caregiver-reported measures before and after the program, with limited follow-up when available. The study does not assign treatments; it uses data from routine clinical care.

What it is studying. The study aims to describe changes in functional and developmental measures—such as attention, motor coordination, oculomotor control, reflex integration, emotional regulation, communication, and daily living skills—measured before and after a two-week intensive multimodal neurorehabilitation program in children with neurodevelopmental, neurologic, or chromosomal conditions.

What the researchers hope to learn. To generate real-world evidence on functional and neurodevelopmental outcomes following a two-week intensive multimodal neurorehabilitation program in pediatric patients with neurodevelopmental, neurologic, or chromosomal disorders, and to inform future controlled studies and program design.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Children with neurodevelopmental disorders often present with complex impairments affecting motor function, sensory processing, communication, attention, emotional regulation, and daily living skills. These conditions may arise from acquired neurologic injury (such as hypoxic ischemic encephalopathy or traumatic brain injury) or from genetic and chromosomal abnormalities (such as Down syndrome, Rett syndrome, or other genomic disorders). Traditional therapy models delivered at low frequency may not fully address the intensity required to drive meaningful neuroplastic change. Intensive, high frequency, and multimodal rehabilitation approaches have been proposed as a strategy to enhance neural adaptation by increasing repetition, engagement, and cross-modal stimulation within a short time period. This observational study is designed to systematically characterize real world outcomes associated with a two week pediatric intensive therapy model that integrates multiple therapeutic modalities tailored to the individual child. This is a prospective observational study of pediatric participants enrolled in an intensive therapy program. No randomization or experimental intervention is introduced as part of the study. All therapies are delivered as part of routine clinical care. Participants attend therapy sessions for approximately 2.5 hours per day, 5 days per week, for 2 consecutive weeks. Therapy is individualized and may include a combination of:

  • Sensory integration techniques
  • Motor planning and coordination activities
  • Reflex integration exercises
  • Oculomotor and visual processing training
  • Auditory processing activities
  • Executive functioning tasks
  • Communication support strategies
  • Emotional regulation training
  • Brain based and neurodevelopmental exercises

Additional modalities such as vibration, tactile stimulation, and photobiomodulation may be used at the discretion of the treating clinician. This study aims to generate real world evidence on the potential benefits of intensive, individualized, multimodal neurorehabilitation in children with complex neurodevelopmental conditions, including those with genetic and chromosomal etiologies. Findings may inform future controlled studies and help guide clinical decision making for therapy intensity and program design.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants attend individualized therapy about 2.5 hours per day, five days a week, for two consecutive weeks. Therapy is delivered as routine clinical care and may include sensory integration, motor planning, reflex integration, oculomotor and auditory training, executive-function and communication activities, emotional-regulation strategies, and—at the treating clinician's discretion—additional modalities such as vibration, tactile stimulation, or photobiomodulation. Clinician-observed assessments and parent/caregiver-reported measures are collected at baseline and at the end of the program, with limited parent-reported follow-up up to four weeks; a parent or legal guardian must provide consent and help with reporting. The registry record does not list any invasive procedures; participation requires attending and completing the full two-week program.

How the study is structured. An observational cohort study using clinical data from children who completed a two-week intensive therapy program. Measures are taken at baseline and at the end of the program, with limited follow-up when available. The record contains inconsistent wording about prospective versus retrospective data collection (time_perspective is listed as RETROSPECTIVE while the detailed description also refers to prospective enrollment). No randomization or study-assigned treatments are involved.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Rett syndrome

This trial is also listed on this site under fragile X syndrome.

Clinical trials20 trials listed for Rett syndromeEvery trial the registry lists for Rett syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Rett syndrome researchLatest monthly update: September 2026. Includes: Seizure add-on drug. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 1, 2026
Primary completion
Jan 1, 2028 (estimated)
Study completion
Dec 30, 2036 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Mar 25, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Healing Hope International

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
legal guardian
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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