Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound

March 12, 2021 updated by: Mouwang Zhou, Peking University Third Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
patients
patients with clinical presentions of change in muscle tone
volunteers
healthy volunteers with normal muscle tone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: through study completion, an average of 1 year
Modified Ashworth Scale of the target muscles
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 16, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20191204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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