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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 : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Neurofibromatosis 1 and 2 (NF1 and NF2) Behavioral: hand-held dynamometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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).
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 9, 2019
Estimated Study Completion Date : September 9, 2019


Arm Intervention/treatment
Active Comparator: Cohort 1
Patients with NF1
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.

Active Comparator: Cohort 2
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672838


Contacts
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Contact: Anna Yaffe 212-263-9945 anna.yaffe@nyulangone.org

Locations
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United States, New York
New York School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Srivandana Akshintala, MD         
Contact: Anna Yaffe    212-263-9945    Anna.Yaffe@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Srivandana Akshintala, MD New York School of Medicine

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03672838     History of Changes
Other Study ID Numbers: 18-00831
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms