Strength Measurement in Intrinsic Foot Muscles With Break and Make Tests

March 12, 2020 updated by: Gokhan Yazici, Gazi University

Comparison of Strength Measurement in Intrinsic Foot Muscles With Break and Make Tests Using a Hand-held Dynamometer in Healthy Young Subjects

The human foot is a complex structure, which serves functions such as support and mobility. These functions are accomplished through the deformation of the arch, which is controlled by intrinsic and extrinsic foot muscles. The intrinsic muscles have an important role in dynamic stabilization of the foot due to their structurally short force levers and small diameters. There are many studies reporting that foot intrinsic muscle weakness is directly related to pathologies such as structural or functional toe deformities, pes planus, hallux valgus, plantar fasciitis .Therefore it is essential to evaluate the strength of these muscles in an objective and reliable way.

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

Two different methods are used in measuring muscle strength via a Hand Held Dynamometer; the "break test" and the "make test" . During these tests, the examiner and subject play opposite roles. During the make test, the subject applies maximal force against the examiner and the position is maintained by the examiner. During the break test, the subject holds the position of the muscle being evaluated and the examiner pushes until the subject's maximal force is overcome. In the two tests, force is applied differently; the dynamometer receives different amounts of force, and different results may be generated. Therefore, the aim of this study was to compare the reliability of intrinsic foot muscle strength assessment with break and make test in healthy young subjects.

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 (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.
77

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

  • Turkey
      • Ankara, Turkey, 06560
        • Gazi University

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sedantary healthy individuals who do not have any orthopedic/neurologic lower extremity problems.

Description

Inclusion Criteria:

  • Sedentary individuals,
  • Category 1 and 2 according to the International Physical Activity Questionnaire
  • Body mass index between the ranges ≥18.5 - <24.9

Exclusion Criteria:

  • Any orthopedic or neurological disorder
  • Previous history of lower extremity surgery
  • Having low back pain
  • Having vestibular or visual system problems
  • Having hallux rigidus or limitus, having a hallux valgus angle over 15 degrees

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

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.
Healthy Adults
Healthy subjects aged 18-35 years were enrolled in this study. The muscle strength assessment of the foot intrinsic muscles was assessed with the make test and the break test. The tests were performed with the hip and knee semiflexed in prone position with a hand-held dynamometer. The experimental protocols and methods were explained in detail to all subjects. All participants provided written informed consent in keeping with the ethical principles of the Declaration of Helsinki.
Other: Muscle Strength Assesment-Make Test
For the make test, the examiner applies resistance in a fixed position and the person being tested exerts a maximum effort against the dynamometer and examiner. The examiner is only required to sustain an isometric contraction and read the highest value on an Hand Held Dynamometer.
Other Names:
  • Make Test
Other: Muscle Strength Assesment-Break Test
For the break test, the examiner applies resistance sufficient to overcome the maximum effort of the person being tested and cause the subject's joint to move in the opposite direction, which results in an eccentric contraction. During this test the limb must move at a constant velocity while the person being tested is asked to achieve a maximum contraction. In addition, the examiner must read the force output reading at the exact time the subject's limb begins to move from the Hand Held Dynamometer.
Other Names:
  • Break Test

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
Foot intrinsic muscle strength with the make test
Time Frame: Once a day for two days.
Reliability of the Make Test
Once a day for two days.
Foot intrinsic muscle strength with the break test
Time Frame: Once a day for two days.
Reliability of the Break test
Once a day for two days.

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.
Gazi 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.
August 5, 2019

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.
December 30, 2019

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.
February 17, 2020

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).
March 11, 2020

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.
March 12, 2020

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.
March 13, 2020

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.
March 13, 2020

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.
March 12, 2020

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, 2020

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.
  • GaziUni

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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