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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04275401
Other study ID # M20191204
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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