Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders (GEN-HOPE)

March 19, 2026 updated by: Healing Hope International

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tamara Tamas, MS RA
  • Phone Number: (863) 354- 5131

Study Locations

  • United States
    • Texas
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Ability and Beyond
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician Assessed Functional Neurodevelopmental Performance
Time Frame: Baseline to end of 2 week intensive program
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neural Timing Accuracy
Time Frame: Baseline to end of 2 week intensive program
Change in neural timing performance during metronome paced motor sequencing tasks, recorded as milliseconds from target rhythm and/or number of steps completed at target accuracy.
Baseline to end of 2 week intensive program
Change in Oculomotor Control
Time Frame: Baseline to end of 2 week intensive program
Change in oculomotor performance assessed by clinician-scored saccadic eye movements and horizontal pursuits, recorded as number correct out of 16 when applicable.
Baseline to end of 2 week intensive program
Change in Primitive Reflex Persistence
Time Frame: Baseline to end of 2 week intensive program
Change in primitive reflex persistence or integration assessed by clinician rating on a 0 to 5 scale and/or reflex status. Reflexes assessed may include TLR, ATNR, STNR, MORO, Rooting, Palmar, Spinal Galant, Spinal Perez, and Babkin, depending on participant presentation.
Baseline to end of 2 week intensive program
Change in Processing Speed and Visual Scanning Time
Time Frame: Baseline to end of 2-week intensive program
Change in processing speed and visual scanning measured by time to complete structured scanning tasks. Depending on participant presentation, tasks may include color, number, word, color-word, 69 arrows, and BD69 scanning activities, as well as sorting number/shape/color. Lower completion time indicates improvement.
Baseline to end of 2-week intensive program
Change in Bilateral Word Taps and Cross Midline Performance
Time Frame: Baseline to end of 2-week intensive program
Change in bilateral word tap performance measured by time to complete assigned 100 series or 200 series pages, with notation of cueing needs for crossing midline when applicable.
Baseline to end of 2-week intensive program
Change in Attention, Activity Tolerance, and Participation in Non Preferred Activities
Time Frame: Baseline to end of 2 week intensive program
Change in ability to sustain engagement in therapeutic activity and participate in non preferred tasks, measured by clinician observation using duration in minutes, percentage of participation, and/or required level of assistance.
Baseline to end of 2 week intensive program
Change in Emotional Self Regulation
Time Frame: Baseline to end of 2 week intensive program
Change in emotional regulation or self regulation assessed by clinician rated delay severity, ability to identify feelings, behavioral response during challenge, and/or level of assistance required for regulation and transitions.
Baseline to end of 2 week intensive program
Parent Reported Functional Carryover and Retention of Gains
Time Frame: Up to 4 weeks after completion of the intensive program
Parent or caregiver reported change in daily functioning after the intensive, including independence in morning or bedtime routines, self care, mealtime behavior, reading speed, communication, community outings, emotional regulation, problem solving, and retention of gains.
Up to 4 weeks after completion of the intensive program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healing Hope International

Investigators

  • Principal Investigator: Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP, Board Certified Pediatric Therapist Executive Director Ability and Beyond Integrated Therapies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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
  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 30, 2036

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHI-ND-OBS-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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