NCT05574556

Brief Summary

The lower limb is the region most affected by fractures in the human body. The magnitude of the trauma can cause injuries to structures adjacent to the fracture, promoting joint instability and consequently predisposition to osteoarthritis. The treatment of fractures can be performed conservatively or surgically, and one of the consequences of the surgery is arthrogenic muscle inhibition, which presents itself as a marked muscle weakness due to inhibition of the central nervous system that prevents adequate muscle activation. However, recruiting the quadriceps is the most commonly used goal to determine the patient's return to activities. Physiotherapy has several resources for the functional activation of the quadriceps muscle, such as neuromuscular electrostimulation (NMES), verbal command of muscle activation and neuromatrix techniques. Thus, the objective of this study will be to analyze, by means of electromyography, the myoelectric activity of the quadriceps muscle in individuals undergoing physical therapy intervention, affected by some fracture of the lower limb.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

October 5, 2022

Last Update Submit

October 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • electromyography

    will be performed an examination of electrical muscle conductance

    one time - during the procedure

Secondary Outcomes (1)

  • myoelectric activity of the quadriceps muscle

    one time - during the procedure

Study Arms (1)

myoelectric activity of the quadriceps muscle

electromyography myoelectric activity of the quadriceps muscle

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ANALYSIS OF THE QUADRICEPS AFTER TRAUMA IN LOWER MEMBERSINTERVENTION

You may qualify if:

  • trauma in lower member intervention

You may not qualify if:

  • neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Cazarini Júnior

São Paulo, São Paulo, 03156001, Brazil

Location

MeSH Terms

Conditions

Leg InjuriesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 10, 2022

Study Start

January 10, 2021

Primary Completion

April 10, 2021

Study Completion

April 10, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations