Gait in Young Children With NF1

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07564622

Enrollment

Registered

2026-05-04

Start date

2026-08-01

Completion date

2031-01-31

Last updated

2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis Type 1

Keywords

NF1, Neurofibromatosis type 1, Gait, Neurodevelopment, gross motor

Brief summary

The objective of this study is to develop office-based tools to quantify gait in young children with NF1 that reflect overall gross motor impairment and predict future gross motor difficulties.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 71 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Developmental Assessment of Young Children (DAYC-2) Score	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	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	Baseline, 12 Months, 24 Months	Measure of gait; how quickly a participant can complete a 10-meter walk.

Contacts

CONTACTDanika Anganoo-Khan

Danika.anganoo-khan@nyulangone.org929-455-5629

CONTACTNicolas Abreu, MD

Nicolas.abreu@nyulangone.org212-263-7744

PRINCIPAL_INVESTIGATORNicolas Abreu, MD

NYU Langone Health

Outcome results