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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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ClinicalTrials.gov Identifier: NCT03672838
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE September 13, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE September 24, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03672838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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).
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neurofibromatosis 1 and 2 (NF1 and NF2)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Cohort 1
    Patients with NF1
    Intervention: Behavioral: hand-held dynamometer
  • Active Comparator: Cohort 2
    Patients with NF2
    Intervention: Behavioral: hand-held dynamometer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anna Yaffe 212-263-9945 anna.yaffe@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03672838
Other Study ID Numbers  ICMJE 18-00831
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

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 Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 5 years following article publication
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will have access to the data.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kaleb H Yohay, MD New York School of Medicine
PRS Account NYU Langone Health
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP