Gait in Young Children With NF1 | Clinical Trial

Key information

Conditions

Neurofibromatosis Type 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurocutaneous Syndromes Neurodegenerative Diseases Neurofibroma Neurofibromatoses Neurofibromatosis 1 Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

Up to 71 month

Sex eligibility

All sexes

Study type

Observational

About this study

In this prospective observational study of ambulatory children less than six years old with NF1, investigators will evaluate gait speed as the fastest time to walk 10 meters and interlimb coordination derived from artificial intelligence-based pose estimates from video. Investigators will conduct office-based gait assessments with video, clinical exams, and neurodevelopmental evaluations during routine medical visits at baseline, 12 months, and 24 months at one of the largest NF1 centers in the U.S., the NYU Comprehensive Neurofibromatosis Center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children who are independently ambulatory who meet revised diagnostic criteria for NF1
Children less than or equal to 71 months of age
Parent/Legal Guardian willing and able to provide parental consent.

Exclusion criteria

Age ≥ 6 years old, inability to walk 10 meters independently, non-NF1 medical illness that alters their physical or neurological abilities that could significantly impact their performance.
Parent/Legal Guardian not willing and able to provide parental consent

Treatment and study plan

Primary outcomes

Developmental Assessment of Young Children (DAYC-2) Score

Time frame: Baseline, 12 Months, 24 Months

Assessment of child neurodevelopmental function in which novel tasks are performed; each task is pass/fail and scored 0 or 1 point. A raw score is calculated and converted to a standard score as follows: <70 (Very Poor); 70-79 (Poor); 80-89 (Below Average); 90-110 (Average); 111-120 (Above Average); 121-130 (Superior); >130 (Very Superior); higher scores indicate greater function.
Vineland Adaptive Behavior Scale Score

Time frame: Baseline, 12 Months, 24 Months

Comprehensive, standardized measure of an individual's personal and social sufficiency to assist in diagnosing intellectual and developmental disabilities, autism spectrum disorder, and ADHD. The raw score is converted to a standardized score with a mean of 100 and standard deviation of 15; higher scores indicate greater daily functioning.
10-Meter Walk Test Score

Time frame: Baseline, 12 Months, 24 Months

Measure of gait; how quickly a participant can complete a 10-meter walk.

Study contacts

Contact information is provided by the study sponsor or research team.

Danika Anganoo-Khan

CONTACT

[email protected]

929-455-5629

Nicolas Abreu, MD

CONTACT

[email protected]

212-263-7744

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Quantitative Gait Metrics to Assess and Predict Gross Motor Impairment in Young Children With Neurofibromatosis Type 1

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2031
First posted: May 4, 2026
Registry last updated: May 8, 2026

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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