Back to resultsA 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)
Primary Purpose
Neurofibromatosis 1 and 2 (NF1 and NF2)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hand-held dynamometer
Sponsored by
About this trial
This is an interventional other trial for Neurofibromatosis 1 and 2 (NF1 and NF2)
Eligibility 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
Sites / Locations
- New York School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cohort 1
Cohort 2
Arm Description
Patients with NF1
Patients with NF2
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
standard error of measurement of measuring strength in the weak muscles
standard error of measurement of measuring strength in the dominant biceps muscle
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03672838
Brief 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)
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).
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis 1 and 2 (NF1 and NF2)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
Patients with NF1
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
Patients with NF2
Intervention Type
Behavioral
Intervention Name(s)
hand-held dynamometer
Intervention Description
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 Measure Information:
Title
Intra-class correlation coefficient of strength measurement in the clinically identified weak muscle
Description
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
Secondary Outcome Measure Information:
Title
Intra-class correlation coefficient of strength measurement in the dominant biceps
Description
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
Title
standard error of measurement of measuring strength in the weak muscles
Time Frame
1 day
Title
standard error of measurement of measuring strength in the dominant biceps muscle
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaleb H Yohay, MD
Organizational Affiliation
New York School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing 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.
Learn more about this trial
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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