Leg InjuryNCT05574556
Electromiographic Analysis of the Quadriceps After Trauma
An observational study of Leg Injury and Bone Fracture, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leg Injury, Bone Fracture
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2021to 10 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: ANALYSIS OF THE QUADRICEPS AFTER TRAUMA IN LOWER MEMBERSINTERVENTION
Who may be able to join
- trauma in lower member intervention
Who cannot join
- neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromiographic Analysis of the Quadriceps in Individuals Undergoing Neuromuscular Electro-stimulation Intervention, Verbal Command and Neuromatrix
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.
- Conditions
- Leg Injury, Bone Fracture
- Medical subject headings
- Leg Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| myoelectric activity of the quadriceps muscle | electromyography myoelectric activity of the quadriceps muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
electromyography
will be performed an examination of electrical muscle conductance
Measured: one time - during the procedure
Secondary outcomes (1)
myoelectric activity of the quadriceps muscle
will be performed an examination of electrical muscle conductance
Measured: one time - during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start10 Jan 2021
- Primary completion10 Apr 2021
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574556
- Sponsor's protocol ID
- Electromiographic Analysis
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromiographic Analysis of the Quadriceps in Individuals Undergoing Neuromuscular Electro-stimulation Intervention, Verbal Command and Neuromatrix
- ClinicalTrials.gov ID
- NCT05574556
- Acronym / sponsor ID
- Electromiographic Analysis
- Conditions
- Leg Injury, Bone Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myoelectric activity of the quadriceps muscle | – | –electromyography myoelectric activity of the quadriceps muscle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ANALYSIS OF THE QUADRICEPS AFTER TRAUMA IN LOWER MEMBERSINTERVENTION
Key inclusion criteria (1 listed)
- trauma in lower member intervention
Key exclusion criteria (1 listed)
- neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
electromyography
Time frame: one time - during the procedure
will be performed an examination of electrical muscle conductance
1 secondary outcome
myoelectric activity of the quadriceps muscle
Time frame: one time - during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Injury and Bone Fracture, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electromyography (time frame: one time - during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.