Gait in Young Children With NF1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurofibromatosis Type 1. Basic parameters: up to 71 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quantitative Gait Metrics to Assess and Predict Gross Motor Impairment in Young Children With Neurofibromatosis Type 1
Overview
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.
Primary outcome measures
- Developmental Assessment of Young Children (DAYC-2) Score [Time frame: Baseline, 12 Months, 24 Months]
- Vineland Adaptive Behavior Scale Score [Time frame: Baseline, 12 Months, 24 Months]
- 10-Meter Walk Test Score [Time frame: Baseline, 12 Months, 24 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07564622 · 25-01038 · 1K23NS146694