What Are the Effects of Lower Limb Dysmetria on Gluteus Medius and Erector Spinae Musculature? (s-EMG)

April 29, 2024 updated by: Camilo Jose Cela University

Changes in Activity of Erector Spinae and Gluteus Medius Muscles With the Presence of Simulated Lower Limb Dysmetria

Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex.

The aim of present study was to investigate whether modifying lower limb length with a different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Background: Length leg discrepancy (LLD), regardless of its origin, is a very common pathology that can contribute to low back pain. Various authors point out its relationship with the lack of activation of both the gluteus medius (GM) and the ipsilateral erector spinae (ES). The purpose of this study was to identify the activation of Es and GM with different simulated LLD, correlating said activation with the LBP. In turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ. (2) Method: a sample of healthy subjects was selected to whom an artificial LLD was incorporated through a 0.5, 1 and 1.5 cm insole, measuring with EMGs in these 3 moments while walking and performing a counter movement jump (CMJ). The measurement was carried out in random order, in terms of insole height, using a Latin Square. Muscle activation patterns were recorded for 30 seconds at each of the insole heights while walking at 5.7 km/h and compared with the maximum voluntary contraction (MVC), both on the ipsilateral and contra-lateral sides. These muscles were then measured under the same circumstances during the development of the CMJ. (3)

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.
Interventional

Enrollment (Actual)

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.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Villanueva De La Cañada, Madrid, Spain
        • Juan Hernández Lougedo

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • The volunteers had no problems in range of motion of joints of the lower limbs
  • pelvic obliquity due to a functional leg length discrepancy.
  • obesity with body mass index (BMI) 35 > kg/m²

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: 0,5 cm jig
A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.
Other: To evaluate the response of an orthopedic insole
To evaluate the response of an orthopedic insole of different heights on gait.
Other: evaluate activation of musculature
To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.
Experimental: 1 cm jig
A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.
Other: To evaluate the response of an orthopedic insole
To evaluate the response of an orthopedic insole of different heights on gait.
Other: evaluate activation of musculature
To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.
Experimental: 1,5 cm jig
A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.
Other: To evaluate the response of an orthopedic insole
To evaluate the response of an orthopedic insole of different heights on gait.
Other: evaluate activation of musculature
To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.

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
Height CMJ
Time Frame: 1 week
CMJ jump flight height
1 week
Height DJ LEFT
Time Frame: 1 week
Flying height in drop jump left leg
1 week
Height DJ RIGHT
Time Frame: 1 week
Flying height in drop jump right leg
1 week
Gluteus medius (mv)
Time Frame: 1 week
Gluteus medius activation (mv)
1 week
Erector Spinae (mv)
Time Frame: 1 week
Erector Spinae activation (mv)
1 week

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.
Camilo Jose Cela University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eduardo Cimadevilla, PT, Camilo Jose Cela University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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.
March 20, 2023

Primary Completion (Actual)

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 3, 2023

Study Completion (Actual)

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.
September 8, 2023

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).
December 4, 2023

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.
January 11, 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.
January 23, 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.
April 30, 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.
April 29, 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.
April 1, 2024

More Information

Terms related to this study

Keywords

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.
  • CamiloJcU-Fisio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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