Muscle Activation of the Lower Limb in Response to a Medio-lateral Imbalance in Monopodal Stance (SM01)

October 13, 2022 updated by: Manusapiens

Muscle Activation of the Lower Limb in Healthy Subjects in Response to a Medio-lateral Imbalance in Monopodal Stance: a Preliminary Study

The "static" single-leg stance has been extensively studied in the literature for its relevance in functional evaluation, therapeutic exercise, sports training and research for fall prevention (particularly for the elderly and patients with neurological diseases). However, the motor strategies of the supporting limb have been investigated only at the ankle level. In particular it is not known, at the hip, how the muscular system reacts to medial and lateral imbalances. Colonna has hypothesized, basing on a myofascial chains approach, that the balance is managed by the front and back spiral chains. The aim of the present study is to perform a preliminary experimental analysis to verify Colonna's hypothesis, testing a method for the investigation of motor strategies underlying equilibrium.

Five healthy subjects will be examined by means of electromyographic analysis of the gluteus maximus, gluteus medius, adductor longus, tibialis anterior and peroneus longus. Subjects will undergo perturbations of their monopodal balance.

Study Overview

Status

Status

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

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

The subjects involved in the research will be analyzed at the LAMBDA laboratory (UDGEE), AUSL-IRCCS (Azienda Unità Sanitaria Locale-Istituto di Ricovero e Cura a Carattere Scientifico) di Reggio Emilia.

The analysis will be carried out on the right lower limb of each subject. The electromyographic devices will be applied to the tibialis anterior, peroneus longus, gluteus medius, gluteus maximus and adductor longus.

Reflective markers will then be applied (using double-sided tape) according to the Total3DGait protocol, which identifies the body segments of the forearms, arms, trunk, pelvis, thighs, legs, and feet.

The subject must position himself with his right foot on a force platform. The toe of the left foot will be allowed to rest on the ground (on the other power platform posteriorly placed), with the verbal indication to load as little weight as possible on it: this indication is aimed at reducing muscle activation in the absence of external perturbations, in order to highlight only the activity caused by the perturbations themselves. Only acquisitions in which the load on the left foot will be less than 30% of the weight will be considered valid.

The hands will be placed on the hips to limit the variables to be controlled and to standardize the posture, in order to focus the contribution to the balance of the lower limb. The left thigh has to be kept vertical. Finally, it will be required to find, within the constraints described above, the posture that is as comfortable as possible, with minimal muscle contraction. The distance between the feet is therefore freely chosen by each subject.

The operator positions himself behind the subject to be examined, and without being seen performs lateral thrusts with the medial margin of the hand at the proximal third of the thigh. At least ten pushes per side will be performed, with random timing. The thrusts will be quick but without causing pain.

The operator will then request maximal contractions from the subject, in order to normalize the electrical activity of each muscle with respect to its maximum. It will be required to perform the dorsiflexion and pronation of the foot against resistance, then the adduction, abduction and extension of the hip.

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.
5

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

  • Italy
      • Reggio Emilia, Italy, 42122
        • AUSL-IRCCS di Reggio Emilia

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All healthy subjects

Exclusion Criteria:

  • skeletal pathologies compromising balance
  • neuromotor pathologies compromising balance

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: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Unbalanced healthy subjects
Subjects undergo an external perturbation of their balance
Other: Medio-lateral imbalance
Thrust on the pelvis in the medio-lateral direction in order to create a balance perturbation

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
Maximum electrical intensity during early response of muscle activation
Time Frame: During the procedure
The muscles considered will be, for the anterior spiral chain, the adductor longus and the peroneus longus, for the posterior spiral chain, the glutei (medius and maximus) and the tibialis anterior. For each muscle, the intensity will be normalized to the intensity of the maximal contraction. Muscle activity will be evaluated for 1500ms, 500ms before and 1000ms after the thrust. The early response to the stimulus will be identified in the interval of 100-500ms after the thrust.The thrusts will be performed 10 times towards the medial direction and 10 towards the lateral. The median intensity for each direction will be calculated.
During the procedure
Correlation of muscle activity
Time Frame: During the procedure
Correlation coefficients of the activation intensity between each muscle of the hip and each muscle of the ankle: tibialis anterior-glutei; tibialis anterior-adductor longus; peroneus longus-glutei; peroneus longus-adductor longus. Calculated for each imbalance direction.
During the procedure

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.
Manusapiens

Publications and helpful links

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General Publications

Study record dates

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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.
August 1, 2021

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.
November 1, 2021

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.
December 30, 2021

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).
August 26, 2021

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.
October 1, 2021

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.
October 15, 2021

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.
October 17, 2022

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.
October 13, 2022

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.
October 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 957/2020/SPER/AUSLRE

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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