An interventional study of hand-held dynamometer in Neurofibromatosis 1 and 2 (NF1 and NF2), sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Other
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.
186 studies on the registry are indexed under Neurofibromatoses; 24 are open to participants now.
This study's enrollment of 33 is above the median of 26 across 120 interventional studies indexed under Neurofibromatoses.
Browse Neurofibromatoses studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
For cohort 1:
For Cohort 2
Exclusion Criteria:
Patients with NF1
Behavioral: hand-held dynamometer
Patients with NF2
Behavioral: hand-held dynamometer
Strength of one weak muscle group and of the biceps of the dominant arm will be measured using a hand-held dynamometer. An average of three readings will be used as one observation. Three observations per patient will be obtained on one day with a minimum of 15 minute rest period between each observation.
Intra-class correlation coefficient of strength measurement in the clinically identified weak muscle
A sample size of 20 subjects with three observations per subject achieves 90% power to detect an intraclass correlation of 0.91 under the alternative hypothesis when the intraclass correlation under the null hypothesis is 0.75 using an F-test with a significance level of 0.05.
Time frame: 1 day
Intra-class correlation coefficient of strength measurement in the dominant biceps
A sample size of 20 subjects with three observations per subject achieves 90% power to detect an intraclass correlation of 0.91 under the alternative hypothesis when the intraclass correlation under the null hypothesis is 0.75 using an F-test with a significance level of 0.05.
Time frame: 1 day
standard error of measurement of measuring strength in the weak muscles
Time frame: 1 day
standard error of measurement of measuring strength in the dominant biceps muscle
Time frame: 1 day
Plan to share: Yes — De-identified data for patients who consent for their data to be shared for future research. The data will be made available: Requests should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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