NCT05200780

Brief Summary

1-standardization of semi quantitative muscle ultrasonographic parameters ( muscle thickness (MT) and echo intensity (EI) ) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs. 2.standardizaition of quantitative muscle ultrasonographic parameters (Gray scale level (GSL), Calibrated muscle backscatter values (cMBs), Optical Density (OD), 2D Textu1) in healthy adults and to obtain a set of normal values of all accessible muscle in both upper and lower limbs.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 1, 2022

Last Update Submit

January 14, 2022

Conditions

Muscle Disease

Outcome Measures

Primary Outcomes (1)

  • get a refrence for ultrasonographic parameters muscle

    1. use new, easy ,non-invasive tool "neuromuscular ultrasound" 2. ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle. 1\_use new, easy ,non-invasive tool "neuromuscular ultrasound" 2\_ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.1\_use new, easy ,non-invasive tool "neuromuscular ultrasound" 2\_ultrasound give important morphological information of the muscles and can differentiate normal and diseased muscle.

    10 months

Secondary Outcomes (1)

  • detect early pathological changes in muscles

    8 months

Interventions

ultrasoundDEVICE

All subjects will undergo the tests with the same machine. Transverse ultrasound images were obtained using the Philips HD with a 4-12 MHz probe. in neurosonology unit in neurology department.

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Healthy subjects were recruited amongst colleagues and family members of the researchers 2. Age group (5-70)years 3. Male and female.

You may qualify if:

  • Healthy subjects were recruited amongst colleagues and family members of the researchers
  • Age group (5-70)years
  • Male and female.

You may not qualify if:

  • Patient refuse to participate
  • The anatomy is altered due to sever trauma,tumor,or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Heckmatt JZ, Dubowitz V, Leeman S. Detection of pathological change in dystrophic muscle with B-scan ultrasound imaging. Lancet. 1980 Jun 28;1(8183):1389-90. doi: 10.1016/s0140-6736(80)92656-2.

    PMID: 6104175BACKGROUND

  • Reimers CD, Schlotter B, Eicke BM, Witt TN. Calf enlargement in neuromuscular diseases: a quantitative ultrasound study in 350 patients and review of the literature. J Neurol Sci. 1996 Nov;143(1-2):46-56. doi: 10.1016/s0022-510x(96)00037-8.

    PMID: 8981297BACKGROUND

  • Pillen S, Verrips A, van Alfen N, Arts IM, Sie LT, Zwarts MJ. Quantitative skeletal muscle ultrasound: diagnostic value in childhood neuromuscular disease. Neuromuscul Disord. 2007 Jul;17(7):509-16. doi: 10.1016/j.nmd.2007.03.008. Epub 2007 May 29.

    PMID: 17537635BACKGROUND

  • Walker FO, Cartwright MS, Wiesler ER, Caress J. Ultrasound of nerve and muscle. Clin Neurophysiol. 2004 Mar;115(3):495-507. doi: 10.1016/j.clinph.2003.10.022.

    PMID: 15036045BACKGROUND

  • Pillen S, van Keimpema M, Nievelstein RA, Verrips A, van Kruijsbergen-Raijmann W, Zwarts MJ. Skeletal muscle ultrasonography: Visual versus quantitative evaluation. Ultrasound Med Biol. 2006 Sep;32(9):1315-21. doi: 10.1016/j.ultrasmedbio.2006.05.028.

    PMID: 16965971BACKGROUND

  • Arts IM, Pillen S, Schelhaas HJ, Overeem S, Zwarts MJ. Normal values for quantitative muscle ultrasonography in adults. Muscle Nerve. 2010 Jan;41(1):32-41. doi: 10.1002/mus.21458.

    PMID: 19722256BACKGROUND

MeSH Terms

Conditions

Muscular Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ghaydaa Ahmed shehata, prof

    medical service affiliation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

doaa soliman abdelhafeez

CONTACT

01033427347doaasoliman133555@gmail.com

Khaled Osama Mohamed, Ass .prof

CONTACT

01003012229Khalednao26@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Standardization of quantitative muscle ultrasonographic parameters among Egyptian population

Study Record Dates

First Submitted

January 1, 2022

First Posted

January 21, 2022

Study Start

February 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

January 21, 2022

Record last verified: 2022-01