Quantitative Gait Metrics to Assess and Predict Gross Motor Impairment in Young Children With Neurofibromatosis Type 1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Developmental Assessment of Young Children (DAYC-2) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Young Children with NF1
Ambulatory children less than 6 years old with NF1.
结局指标
主要结局
Developmental Assessment of Young Children (DAYC-2) Score
时间窗: 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
时间窗: 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
时间窗: Baseline, 12 Months, 24 Months
Measure of gait; how quickly a participant can complete a 10-meter walk.
次要结局
未报告次要终点