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NCT Number: NCT03672838

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)

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.

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Key information

Conditions

Neurofibromatosis 1 and 2 (NF1 and NF2) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurilemmoma Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibromatoses Neurofibromatosis 1 Neurofibromatosis 2 Neuroma Neuroma, Acoustic Neuromuscular Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Peripheral Nervous System Diseases Retrocochlear Diseases Vestibulocochlear Nerve Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • No orthopedic procedure or other major surgery that could influence extremity strength in past 6 months
  • No tibial dysplasia

Treatment and study plan

hand-held dynamometer

Behavioral

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.

Primary outcomes

  1. Intra-class correlation coefficient of strength measurement in the clinically identified weak muscle

    Time frame: 1 day

    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.

Secondary outcomes

  1. Intra-class correlation coefficient of strength measurement in the dominant biceps

    Time frame: 1 day

    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.

  2. standard error of measurement of measuring strength in the weak muscles

    Time frame: 1 day

  3. standard error of measurement of measuring strength in the dominant biceps muscle

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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).

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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