NCT04043832

Brief Summary

In addition to muscle thickness and average echo intensity, this study aimed to use quantitative ultrasonic technology to increase the number of related parameters of power Doppler ultrasonography measured to describe the number, quality, and recruitment level of muscles. In addition, this method was compared with the existing muscle strength testing methods. Image recognition was performed using the traditional multivariate linear regression statistical method and the AI convolutional neural network algorithm to investigate the application of quantitative ultrasonic technology for direct evaluation of muscle strength in clinical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 11, 2019

Last Update Submit

July 31, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Multivariate linear regression results

    The quantitative ultrasonic technology parameters (muscle thickness, average muscle echo intensity, and corrected power ultrasonic intensity) and muscle strength parameter (knee extension peak torque) were introduced into SPSS 6.0 for data processing via multivariate linear correlation analysis.

    2/6/2019

Interventions

Collection of all quantitative ultrasonic data was performed by one ultrasound physician

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study recruited 80 volunteers including 54 healthy volunteers, 24 unilateral quadriceps atrophy patients and 2 bilateral quadriceps atrophy patients

You may qualify if:

  • no major complaints of muscle numbness, spasm, or atrophy, muscle-related physical activity impairment or joint swelling and pain
  • no obvious malformation in the lower limbs
  • no disease history in the musculoskeletal system, nervous system, and peripheral blood,
  • no history of severe trauma in the lower limbs
  • joint mobility and muscle tension met the thresholds of muscle strength assessments
  • no severe osteoporosis
  • no acute inflammation or acute bone fracture repair
  • between 18-55 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Univercity Third Hospital

Beijing, No State Or Province, 100191, China

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Jingfeng Li, Bachelor

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

August 2, 2019

Study Start

May 1, 2017

Primary Completion

May 15, 2019

Study Completion

June 1, 2019

Last Updated

August 2, 2019

Record last verified: 2019-07

Locations