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)

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NYU Langone Health

Status

Completed

Conditions

Neurofibromatosis 1 and 2 (NF1 and NF2)

Treatments

Behavioral: hand-held dynamometer

Study type

Interventional

Funder types

Other

Identifiers

NCT03672838
18-00831

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups

Cohort 1
Active Comparator group
Description:
Patients with NF1
Treatment:
Behavioral: hand-held dynamometer
Cohort 2
Active Comparator group
Description:
Patients with NF2
Treatment:
Behavioral: hand-held dynamometer

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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