Muscle Tone IncreasedNCT04275401
Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
An observational study of Muscle Tone Increased and Ultrasonography, run by Peking University Third Hospital at 1 site in China.
Trial summary
The test subjects were selected from patients with clinical manifestations in muscle tone and healthy volunteers. Elbow flexor is the main target muscle. Fifty patients and 50 healthy subjects were given three assessment methods to measure muscle tension: modified Ashworth rating scale, elastic ultrasound technology… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Increased, Ultrasonography
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is expected to recruit 50 patients with clinical changes in flexion of the elbow flexor and 50 healthy subjects to participate in the study.
Who may be able to join
- There are clinical manifestations of changes in muscle tension of the elbow flexor group;
- Subject's diagnosis is clear;
- The degree of joint mobility meets the method of muscle tension assessment.
Who cannot join
- Has serious diseases such as heart, lung, liver, kidney, etc., cardiac function grade is greater than Grade I (NYHA), has symptoms and signs or examination results such as respiratory failure;
- History of muscle disorders;
- Recent (within 6 months) history of external injury, fracture or surgery of the limb;
- Are using drugs that affect muscle tone;
- Severe osteoporosis;
- Acute phase of inflammation
- Acute limb thrombosis of the subject;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Xinpei Zhang, Bachelor contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Mouwang Zhou, Doctor, 13910092892, zhoumouwang@163.com
About this study
Official title: Study on Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
The test subjects were selected from patients with clinical manifestations in muscle tone and healthy volunteers. Elbow flexor is the main target muscle. Fifty patients and 50 healthy subjects were given three assessment methods to measure muscle tension: modified Ashworth rating scale, elastic ultrasound technology and surface electromyography, and the data obtained by these three methods will be statistically analyzed and discussed.
- Conditions
- Muscle Tone Increased, Ultrasonography
- Medical subject headings
- Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | patients with clinical presentions of change in muscle tone | |
| volunteers | healthy volunteers with normal muscle tone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Modified Ashworth Scale of the target muscles
Measured: through study completion, an average of 1 year
shear wave elastography
use shear wave elastography to evaluate Young's modules of target muscles at each angle of the joint during the passive movement
Measured: through study completion, an average of 1 year
surface electromyography
use surface electromyography to evaluate average EMG, integrated electromyogram and root mean square of the target muscles
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tone IncreasedStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouwang Zhou, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275401
- Sponsor's protocol ID
- M20191204
- Status last verified
- Mar 2021
- First submitted
- 6 Feb 2020
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
- ClinicalTrials.gov ID
- NCT04275401
- Acronym / sponsor ID
- M20191204
- Conditions
- Muscle Tone Increased, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 Feb 2020 (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.
The test subjects were selected from patients with clinical manifestations in muscle tone and healthy volunteers. Elbow flexor is the main target muscle. Fifty patients and 50 healthy subjects were given three assessment methods to measure muscle tension: modified Ashworth rating scale, elastic ultrasound technology and surface electromyography, and the data obtained by these three methods will be statistically analyzed and discussed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –patients with clinical presentions of change in muscle tone |
| volunteers | – | –healthy volunteers with normal muscle tone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is expected to recruit 50 patients with clinical changes in flexion of the elbow flexor and 50 healthy subjects to participate in the study.
Key inclusion criteria (3 listed)
- There are clinical manifestations of changes in muscle tension of the elbow flexor group;
- Subject's diagnosis is clear;
- The degree of joint mobility meets the method of muscle tension assessment.
Key exclusion criteria (8 listed)
- Has serious diseases such as heart, lung, liver, kidney, etc., cardiac function grade is greater than Grade I (NYHA), has symptoms and signs or examination results such as respiratory failure;
- History of muscle disorders;
- Recent (within 6 months) history of external injury, fracture or surgery of the limb;
- Are using drugs that affect muscle tone;
- Severe osteoporosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Ashworth Scale
Time frame: through study completion, an average of 1 year
Modified Ashworth Scale of the target muscles
shear wave elastography
Time frame: through study completion, an average of 1 year
use shear wave elastography to evaluate Young's modules of target muscles at each angle of the joint during the passive movement
surface electromyography
Time frame: through study completion, an average of 1 year
use surface electromyography to evaluate average EMG, integrated electromyogram and root mean square of the target muscles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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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.
Xinpei Zhang, Bachelor contact
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 Tone Increased and Ultrasonography, 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mouwang Zhou, Doctor (13910092892, zhoumouwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 16 Mar 2021.