An observational study in Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD) and Neurodevelopmental Disorders and Developmental Abnormalities, sponsored by Healing Hope International. Recruiting at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Healing Hope International · Observational
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.
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:
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.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 133 observational studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →Healing Hope International is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline to end of 2 week intensive program
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 weeks after completion of the intensive program
Plan to share: Undecided
Started Mar 2026 (actual). Primary completion is estimated for Jan 2028, 22 months after the start.
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