A Single Center Pilot Study to Assess the Intra-observer Reliability of Measuring Muscle Strength Using a Hand Held Dynamometer in Children and Adults With Neurofibromatosis Type 1 (NF1) and Type 2 (NF2)
Completed · Not applicable
Conditions studied: Neurofibromatosis 1 and 2 (NF1 and NF2)
In brief
Patients with clinically confirmed neurofibromatosis type 1 (NF1) or neurofibromatosis type 2 (NF2) or a known neurofibromatosis (NF) mutation aged 5 years and above will be eligible to participate and will be recruited from the neurofibromatosis clinic. Given the need for identifying measures that can reliably and sensitively measure focal muscle weakness and allow for measuring muscle strength as a functional outcome in therapeutic clinical trials in NF, this pilot study will assess the reliability of measuring muscle strength in NF1 and NF2 using a hand-held dynamometer.
Key facts
- Study ID
- NCT03672838
- Run by
- NYU Langone Health
- People needed
- 33
- Starts
- 2018-09-24
- Expected to finish
- 2019-12-02
- Last updated by the study team
- 2021-03-18
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For cohort 1:
- Patients must have clinically confirmed NF1 using the NIH consensus criteria or a known NF1 mutation
- Ages 5 years and above
- < 5/5 strength on Manual Muscle Testing (MMT) testing in at least one muscle group tested on the day of enrollment
- Able to follow instructions and cooperate with exam to assess strength
- For Cohort 2
- Patients must have clinically (NIH or Manchester criteria) or genetically confirmed diagnosis of NF2
- Ages 5 years and above
- < 5/5 strength on MMT testing in at least one muscle group tested on the day of enrollment
- Able to follow instructions and cooperate with exam to assess strength
You may not qualify if…
- No orthopedic procedure or other major surgery that could influence extremity strength in past 6 months
- No tibial dysplasia
Where it is running
- New York School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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