Neurodevelopmental DisordersGEN-HOPENCT07493096
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
An observational study of Neurodevelopmental Disorders and Neurodevelopmental Disorders (NDD), run by Healing Hope International at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Dec 2036
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamara Tamas, MS RA contact
United States1 site, 1 recruiting
- Recruiting
Ability and Beyond
The Woodlands, Texas, 77380
Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP, 936-271-1337, tina@abilityandbeyond.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders, 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
- 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
- Medical subject headings
- Neurodevelopmental Disorders, Developmental Disabilities, Cerebral Palsy, Autism Spectrum Disorder, Hypoxia-Ischemia, Brain, Brain Injuries, Traumatic, Chromosome Aberrations, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of 2 week intensive program
Secondary outcomes (8)
Change in Neural Timing Accuracy
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.
Measured: Baseline to end of 2 week intensive program
Change in Oculomotor Control
Change in oculomotor performance assessed by clinician-scored saccadic eye movements and horizontal pursuits, recorded as number correct out of 16 when applicable.
Measured: Baseline to end of 2 week intensive program
Change in Primitive Reflex Persistence
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.
Measured: Baseline to end of 2 week intensive program
Change in Processing Speed and Visual Scanning Time
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.
Measured: Baseline to end of 2-week intensive program
Change in Bilateral Word Taps and Cross Midline Performance
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.
Measured: Baseline to end of 2-week intensive program
Change in Attention, Activity Tolerance, and Participation in Non Preferred Activities
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.
Measured: Baseline to end of 2 week intensive program
Change in Emotional Self Regulation
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.
Measured: Baseline to end of 2 week intensive program
Parent Reported Functional Carryover and Retention of Gains
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.
Measured: Up to 4 weeks after completion of the intensive program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healing Hope International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP, Principal investigator, Board Certified Pediatric Therapist Executive Director Ability and Beyond Integrated Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493096
- Sponsor's protocol ID
- HHI-ND-OBS-2025-001
- Acronym
- GEN-HOPE
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 RN. Delivering evidence-based upper limb rehabilitation for children with cerebral palsy: barriers and enablers identified by three pediatric teams. Phys Occup Ther Pediatr. 2014 Nov;34(4):368-83. doi: 10.3109/01942638.2013.861890. Epub 2013 Dec 4.
PubMed 24303800Novak I, Honan I. Effectiveness of paediatric occupational therapy for children with disabilities: A systematic review. Aust Occup Ther J. 2019 Jun;66(3):258-273. doi: 10.1111/1440-1630.12573. Epub 2019 Apr 10.
PubMed 30968419Bower, 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