Clinical trial · Observational
Gait in Young Children With NF1
Quantitative Gait Metrics to Assess and Predict Gross Motor Impairment in Young Children With Neurofibromatosis Type 1
NCT07564622CI-TRIAL-00110975not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis Type 1 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Young Children with NF1
- description
- Ambulatory children less than 6 years old with NF1.
Primary outcomes (3)
- measure
- Developmental Assessment of Young Children (DAYC-2) Score
- timeFrame
- Baseline, 12 Months, 24 Months
- description
- 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.
- measure
- Vineland Adaptive Behavior Scale Score
- timeFrame
- Baseline, 12 Months, 24 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 71 Months
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.