Gait in Young Children With NF1
ConditionNeurofibromatosis Type 1
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 71
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Children who are independently ambulatory who meet revised diagnostic criteria for NF1
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
56 Participants
are grouped into 1 trial groupGroup A: Young Children with NF1
Trial outcomes
Primary outcomes
1
Developmental Assessment of Young Children (DAYC-2) Score
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.
Time frame
Baseline, 12 Months, 24 Months2
Vineland Adaptive Behavior Scale Score
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.
Time frame
Baseline, 12 Months, 24 Months3
10-Meter Walk Test Score
Measure of gait; how quickly a participant can complete a 10-meter walk.
Time frame
Baseline, 12 Months, 24 MonthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: