Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
Study on Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
1 other identifier
observational
40
1 country
1
Brief 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 and surface electromyography, and the data obtained by these three methods will be statistically analyzed and discussed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMarch 16, 2021
March 1, 2021
1.9 years
February 6, 2020
March 12, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Modified Ashworth Scale
Modified Ashworth Scale of the target muscles
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
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
through study completion, an average of 1 year
Study Arms (2)
patients
patients with clinical presentions of change in muscle tone
volunteers
healthy volunteers with normal muscle tone
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 19, 2020
Study Start
December 1, 2019
Primary Completion
November 1, 2021
Study Completion
April 1, 2022
Last Updated
March 16, 2021
Record last verified: 2021-03