Muscle DisorderNCT04043832
A New Method of Muscle Strength Testing Using a Quantitative Ultrasonic Technique and a Convolutional Neural Network
An observational study of Muscle Disorder, run by Peking University Third Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Disorder
- What is being tested?
- quantitative ultrasonic technique
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Jun 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study recruited 80 volunteers including 54 healthy volunteers, 24 unilateral quadriceps atrophy patients and 2 bilateral quadriceps atrophy patients
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Univercity Third Hospital
Beijing, No State Or Province, 100191
About this study
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.
Read the 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.
- Conditions
- Muscle Disorder
- Being tested
- quantitative ultrasonic technique
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative ultrasonic techniqueDiagnostic test
Collection of all quantitative ultrasonic data was performed by one ultrasound physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Multivariate linear regression results
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.
Measured: 2/6/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 May 2017
- Primary completion15 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DisorderStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingfeng Li, Bachelor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043832
- Sponsor's protocol ID
- M20190702
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method of Muscle Strength Testing Using a Quantitative Ultrasonic Technique and a Convolutional Neural Network
- ClinicalTrials.gov ID
- NCT04043832
- Acronym / sponsor ID
- M20190702
- Conditions
- Muscle Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study recruited 80 volunteers including 54 healthy volunteers, 24 unilateral quadriceps atrophy patients and 2 bilateral quadriceps atrophy patients
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quantitative ultrasonic techniqueCollection of all quantitative ultrasonic data was performed by one ultrasound physician | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingfeng Li, Bachelor principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Disorder, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariate linear regression results (time frame: 2/6/2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.