Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training

August 8, 2021 updated by: Ariel University

Peroneal Muscles Response to Expected and Unexpected Falls Among Young and Middle-aged Adults Before and After Neuromuscular Training: a Cross Sectional-controlled Trial

Proper functioning of the ankle musculature, specifically peroneal muscles, is crucial for maintaining balance and reducing the risk for falls. Evidence suggests that a decrease in aspects of neuromuscular control already starts at midlife (45-65 years). However, there is almost no information regarding the function of the ankle muscles at the middle-age as most experiments have compared young (<35 years) and older subjects (>65 years). Moreover, neuromuscular training can improve the function of ankle muscle in response to perturbation; yet, no previous study has compared the level of effectiveness between middle-aged and young adults.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Anticipated)

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.
50

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Ariel, Israel
        • Recruiting
        • Ariel University -The Neuromuscular & Human performance laboratory
        • Contact:
        • Principal Investigator:
          • shmuel springer
        • Contact:

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy participants- Twenty-five middle-aged (50-65years) and 25 young adults (20-35 years) will be recruited.

Description

Inclusion Criteria:

- Healthy participants

Exclusion Criteria:

  • Neurological disease accompanied by motor, sensory or cognitive impairment.
  • Illness or condition that does not allow strenuous activity.
  • Significant orthopedic injury to the back or lower limbs in the last six months, which limits strenuous activity or weight-bearing.
  • History of orthopedic injury that includes injury to the knee or ankle ligaments.
  • Taking medications that may affect stability or balance. Significant visual impairment that is not corrected using glasses/contact lenses
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Young adults
18<age<35
Other: Electromyograph Biofeedback training of the peroneal muscle
The exercise will be performed with the subject sitting in front of a computer monitor, on an elevated chair, and his feet will be in the air. The examiner will ask the subject to perform a maximum contraction of the paronal muscles, in an open kinematic chain. After reference, the subject will begin a five-minute practice. The practice will be divided into rounds of: eight seconds of muscle work and 15 seconds rest.
Middle aged adults
50<age<65
Other: Electromyograph Biofeedback training of the peroneal muscle
The exercise will be performed with the subject sitting in front of a computer monitor, on an elevated chair, and his feet will be in the air. The examiner will ask the subject to perform a maximum contraction of the paronal muscles, in an open kinematic chain. After reference, the subject will begin a five-minute practice. The practice will be divided into rounds of: eight seconds of muscle work and 15 seconds rest.

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
Time to stabilization
Time Frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall).
Within 24 hours
Electromyography of peroneus longus- "The height of the amplitude"- expected fall
Time Frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the height of the amplitude - expresses the peak of the electrical activity of the muscles.
Within 24 hours
Electromyography of peroneus longus- "Time to Peak"- expected fall
Time Frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the "Time to Peak"- describes the time it takes for the Peroneus longus muscle to reach the peak of its electrical activity.
Within 24 hours
Electromyography of peroneus longus- "Time to Onset"- expected fall
Time Frame: Within 24 hours
Subjects will be asked to jump from a 20 cm high box onto a force plate (i.e., expected fall). electromyography of peroneus longus will be measured the "Time to Onset" - expresses the period that passes from the beginning of the fall to the initial recruitment of the Peroneus longus.
Within 24 hours
Electromyography of peroneus longus- "The height of the amplitude"-unexpected fall
Time Frame: Within 24 hours
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "height of the amplitude" - expresses the peak of the electrical activity of the Peroneus longus muscle.
Within 24 hours
Electromyography of peroneus longus- "Time to Peak"-unexpected fall
Time Frame: Within 24 hours
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "Time to Peak"- describes the time it takes for the Peroneus longus muscle to reach the peak of its electrical activity.
Within 24 hours
Electromyography of peroneus longus- "Time to Onset"-unexpected fall
Time Frame: Within 24 hours
Subjects will stand on a platform during a unilateral sudden 30° inversion platform perturbation that resembles an unexpected fall. electromyography of peroneus longus will be measured the "Time to Onset"- expresses the period that passes from the beginning of the fall to the initial recruitment of the Peroneus longos muscle.
Within 24 hours
Maximal voluntary isometric peroneal contraction force
Time Frame: Within 24 hours
Subject will perform Maximal voluntary isometric peroneal contraction. The force will measured with dynamometer
Within 24 hours

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.
Ariel 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.
July 1, 2021

Primary Completion (Anticipated)

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.
July 1, 2022

Study Completion (Anticipated)

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.
July 1, 2022

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).
July 21, 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.
August 8, 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.
August 16, 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.
August 16, 2021

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.
August 8, 2021

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.
March 1, 2021

More Information

Terms related to this study

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.
  • AU-HEA-SS-20210304:

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings