The Role of Muscle Ultrasound in Assessment of Sample of Patients With Limb-girdle Muscular Dystrophy

May 1, 2024 updated by: Abanoub Bassem Fikry Ramzy, Assiut University
  1. to detect the characteristic patterns of muscle involvement in suspected cases of LGMD using muscle ultrasound
  2. to use the muscle ultrasound findings clinically categorized the different types of LGMD
  3. to correlate the muscle ultrasound findings with the findings of the other assissed scales

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Limb-girdle muscular dystrophies (LGMD) are muscular dystrophies that affect skeletal muscles, mostly proximal (hips and shoulder muscles). They are caused by a mutation in a gene encoding a protein, which is specific to each subtype. LGMD inheritance is either autosomal dominant or recessive. Several types of LGMD were described depending on the causative mutations (1). LGMD is one of inherited myopathies that characterized by selective involvement of muscles. Selectivity is a sign of muscle diseases and helps direct the diagnosis; however, it cannot always be identified clinically; consequently, the importance of using muscle MRI and ultrasound are to detect this selectivity and aid in the diagnosis (2). Ultrasound with a high resolution enables viewing of the muscle, nerve, and nearby structures and can provide real-time information in neuromuscular illnesses (3). Muscle Ultrasound (MUS) can detect the same patterns of muscle affection as MRI (4). In addition, it is safe, accessible, low-cost, and free of ionizing radiation, with no known contraindications and no difficulties associated with MRI, such as claustrophobia, metallic implants, and the requirement for sedation in children; hence, it can be used as a supplemental technique to electro- diagnosis (5). Ultrasound can provide real-time information related to muscle activation and movement patterns; so, selective substitution of muscle ultrasound for MRI can result in significant cost-saving for the health care system (6). However, its primary drawback is that it is operator-dependent and has a limited ability to image deeper structures (7). According to studies, MUS can provide a key provisional probable diagnosis, especially when genetic diagnosis is not accessible or expensive, or to provide guide to the proper genetic testing when it is available (2, 8). In limb girdle pattern of weakness patients, MUS assisted diagnose quadriceps sparing myopathy, selective affection of one head of gastrocnemius as medial head and soleus more than lateral head in FKRP (LGMD2I) and calpain-3 deficiency (LGMD2A), and selective affection of lateral head as in LGMD2B.

(dysferlin) (9). MUS can also help diagnose the treatable types of limb girdle myopathies like POPME by recognizing specific muscle involvement patterns (2). Few research (10), utilized the MUS to detect suspected LGMD, and none compared the MUS findings with those of the different psychometric measures. The present study aims to we aimed to evaluate the role of MUS in the assessment of patients with suspected LGMD to identify characteristic patterns these of muscle involvement in suspected cases of LGMD and to correlate changes with findings of the different psychometric scales.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • Patients presented with clinical manifestations suggestive of LGMD who presented with gradual progressive limb-girdle weakness ,myopathic changes on electromyography and elevated creatine phosphokinase serum level
  • age and sex matched healthy control group as a normal referencce

Description

Inclusion Criteria:

  • gender : both sex are included Willingness to participate in the study and to be subjected to disease related examination and assessments Willing and able to provide informd consent

Exclusion Criteria:

  • patients unable to give informed consent Patients with acute or subacute onset of symptoms of muscle involvement including inflammatory myopathies Patients with systemic diseases causing secondary myopathy

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The role of muscle ultrasound in assessment of a sample of patients with limb-girdle muscular dystrophy
Time Frame: Baseline
The role of muscle ultrasound in assessment of sample of patients with LGMD
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Limb-Girdle Muscular Dystrophy (Other Identifier: Virginia Commonwealth University)

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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