Neurofibromatosis Type 1NCT07564622
Gait in Young Children With NF1
An observational study of Neurofibromatosis Type 1, run by NYU Langone Health.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 71 months
- Conditions the study is for
- Neurofibromatosis Type 1
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 31 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 71 months
- All sexes
- No healthy volunteers
- Child
Study population: Children who are independently ambulatory who meet revised diagnostic criteria for NF1
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quantitative Gait Metrics to Assess and Predict Gross Motor Impairment in Young Children With Neurofibromatosis Type 1
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.
Read the 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.
- Conditions
- Neurofibromatosis Type 1
- Keywords
- NF1, Neurofibromatosis type 1, Gait, Neurodevelopment, gross motor
- Medical subject headings
- Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young Children with NF1 | Ambulatory children less than 6 years old with NF1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 Months, 24 Months
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.
Measured: Baseline, 12 Months, 24 Months
10-Meter Walk Test Score
Measure of gait; how quickly a participant can complete a 10-meter walk.
Measured: Baseline, 12 Months, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startAug 2026 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 1Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Abreu, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564622
- Sponsor's protocol ID
- 25-01038
- Other IDs
- 1K23NS146694
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request immediately following publication, with no end date, or as required by a condition of awards or supporting agreements. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Gait Metrics to Assess and Predict Gross Motor Impairment in Young Children With Neurofibromatosis Type 1
- ClinicalTrials.gov ID
- NCT07564622
- Acronym / sponsor ID
- 25-01038
- Conditions
- Neurofibromatosis Type 1
- Keywords
- NF1, Neurofibromatosis type 1, Gait, Neurodevelopment, gross motor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2026 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Children with NF1 | – | –Ambulatory children less than 6 years old with NF1. |
Who may qualify
- Ages
- Up to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who are independently ambulatory who meet revised diagnostic criteria for NF1
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Developmental Assessment of Young Children (DAYC-2) Score
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 Months, 24 Months
Measure of gait; how quickly a participant can complete a 10-meter walk.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request immediately following publication, with no end date, or as required by a condition of awards or supporting agreements. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Abreu, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatosis Type 1, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danika Anganoo-Khan (929-455-5629, Danika.anganoo-khan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Assessment of Young Children (DAYC-2) Score (time frame: Baseline, 12 Months, 24 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.