Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound

Ultrasonography Clinical Trial

Official title:

Study on Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275401
• Other study ID #: M20191204
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: April 2022

Study information

• Verified date: March 2021
• Source: Peking University Third Hospital
• Contact: Mouwang Zhou, Doctor
• Phone: 13910092892
• Email: zhoumouwang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 and surface electromyography, and the data obtained by these three methods will be statistically analyzed and discussed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Muscle Hypertonia
• Muscle Tone Increased
• Ultrasonography

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale	Modified Ashworth Scale of the target muscles	through study completion, an average of 1 year
Primary	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
Primary	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