Muscle Quality and Percentage of Fat Following a Lower Limb Injury

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    100
  • sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
Updated on 24 January 2021

Summary

The aim of the study is to longitudinally evaluate patient muscle quality in trauma patients with bed rest or altered weight-bearing with the help of a consumer approved non-proprietary muscle impedance-measuring device. Secondary objectives are to identify patient characteristics or treatment protocols that are predictive of poor muscle quality.

Description

The study investigators will identify eligible patients through patient consultations from the Emergency Room. There are 100 patients expected to be enrolled in the study. This study will be carried out at the Montreal General Hospital. Inclusion criteria include patients that have had a trauma requiring admission to orthopedic surgery, that have the ability and willingness to participate that were in a steady state medical condition before trauma.

Although the study investigators may discuss the study with the patient, the consent and enrolment will be performed exclusively by the study assistant who is not directly implicated in the patient's care.

This is an observational study, therefore, there will be no randomization and no study intervention.

The following baseline patient characteristics will be recorded for each enrolled participant: age, sex, occupation, smoker, medical comorbidities, AO classification of the fractures and muscle trauma, the date of the injury and date of the surgery if performed.

A consumer approved non-proprietary muscle impedance-measuring device (Electrical Impedance Myography unit or "EIM") will be applied to the muscle groups of interest. The device is self-contained, battery-powered and certified for use on humans. When applied to the skin, a very weak electrical current is passed between the outer two electrodes. This current is high frequency and alternating in nature. As the current moves through the skin, the subcutaneous fat and the muscle, it loses a little bit of energy due to the resistance of the tissue and this change is then measured. This will be done as soon as possible after the trauma and admission during a daytime visit. The EIM will be used every two days until discharge or the patient has reached a recovery plateau in a physical rehabilitation program. Patients' muscle quality will also be measured at each follow-up visit for 100 weeks and patients will be asked to complete two questionnaires.

Each patient will have a unique identification number used to link the patient information, device and data together.

It is expected for most patients to have decreasing muscle quality and increasing fat percentage as a result of deconditioning. There is no longitudinal data on the time period over which this would occur. There is also little data on how recovery occurs after the period of healing.

This study utilizes new technology that permits objective insight into the post-operative period by providing qualitative measurements. It has been used previously in clinical studies on patients with neuromuscular degenerative disease with reproducible and consistent results. The research team anticipates being able to pinpoint specific targets for mobilization goals and rehabilitation techniques depending on the time frame and muscle groups involved with deconditioning.

Details
Condition LEG INJURY, Trauma Injury, Injury Trauma, lower extremity injury
Treatment Electrical Impedance Myography unit or "EIM"
Clinical Study IdentifierNCT03578705
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Trauma requiring admission to orthopedic surgery because of a lower limb injury
Ability and willingness to participate
Steady state medical condition before trauma

Exclusion Criteria

Age <18
Pre-existing condition that caused pain or limited weight-bearing on either lower extremity before sustaining trauma (for example the use of walking aids)
Pre-existing medical conditions that will confound the study outcomes (muscle conditions) and are known to prevent return to function
Pregnancy
Implanted electrical device such as heart pacemakers
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note