- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043832
A New Method of Muscle Strength Testing Using a Quantitative Ultrasonic Technique and a Convolutional Neural Network
July 31, 2019 updated by: Peking University Third Hospital
In addition to muscle thickness and average echo intensity, this study aimed to use quantitative ultrasonic technology to increase the number of related parameters of power Doppler ultrasonography measured to describe the number, quality, and recruitment level of muscles.
In addition, this method was compared with the existing muscle strength testing methods.
Image recognition was performed using the traditional multivariate linear regression statistical method and the AI convolutional neural network algorithm to investigate the application of quantitative ultrasonic technology for direct evaluation of muscle strength in clinical practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Collection of all quantitative ultrasonic data was performed by one ultrasound physician.
The Aixplorer® series color ultrasonic diagnostic instrument of Supersonic Imagine (France) and an L15-4 linear array probe were used.
The medial head of the quadriceps muscle was measured.
The subjects wore short pants that settled above the knees.
Tight pants were avoided to prevent impaired venous return, which can affect the power Doppler ultrasonography result.
The subjects did not exercise within half an hour before testing.
Two-dimensional images of the subjects' muscles were collected in a quiet resting state and used to measure muscle thickness and the average echo intensity.
The power Doppler images were used to measure the level of muscle hyperemia.
The measurements were performed in the 0° knee extension position and the most prominent part of the medial head of the quadriceps muscle was measured by the ultrasound physician using visualization.
The probe angle was perpendicular to the trajectory of the muscle bundle, and the measurement was performed with the muscle in a relaxed state.
After the measurements, the knee was restrained to complete the isokinetic muscle strength test.
When testing of the last group was completed, the knee was released immediately.
The two-dimensional image and the power Doppler image at the same location were captured and the image acquisition time was no more than 3 s.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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No State Or Province
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Beijing, No State Or Province, China, 100191
- Peking Univercity Third Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study recruited 80 volunteers including 54 healthy volunteers, 24 unilateral quadriceps atrophy patients and 2 bilateral quadriceps atrophy patients
Description
Inclusion Criteria:
- no major complaints of muscle numbness, spasm, or atrophy, muscle-related physical activity impairment or joint swelling and pain
- no obvious malformation in the lower limbs
- no disease history in the musculoskeletal system, nervous system, and peripheral blood,
- no history of severe trauma in the lower limbs
- joint mobility and muscle tension met the thresholds of muscle strength assessments
- no severe osteoporosis
- no acute inflammation or acute bone fracture repair
- between 18-55 years of age
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multivariate linear regression results
Time Frame: 2/6/2019
|
The quantitative ultrasonic technology parameters (muscle thickness, average muscle echo intensity, and corrected power ultrasonic intensity) and muscle strength parameter (knee extension peak torque) were introduced into SPSS 6.0 for data processing via multivariate linear correlation analysis.
|
2/6/2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jingfeng Li, Bachelor, Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2017
Primary Completion (ACTUAL)
May 15, 2019
Study Completion (ACTUAL)
June 1, 2019
Study Registration Dates
First Submitted
July 11, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (ACTUAL)
August 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2019
Last Update Submitted That Met QC Criteria
July 31, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M20190702
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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