Ability and Beyond
The Woodlands, Texas, 77380, United States
Location status: Recruiting
NCT Number: NCT07493096
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.
Interested in participating?
Request Info4 year–12 year
All sexes
Observational
The Woodlands, Texas, 77380, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Genelle Mills, OTR/L
CONTACT
Tamara Tamas, MS RA
CONTACT
Healing Hope International
Other
Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities
Acronym: GEN-HOPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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