- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307758
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
Completed
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
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Ankara, Turkey, 06560
- Gazi University
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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
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 |
Intervention / Treatment |
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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.
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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:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Foot intrinsic muscle strength with the make test
Time Frame: Once a day for two days.
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Reliability of the Make Test
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Once a day for two days.
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Foot intrinsic muscle strength with the break test
Time Frame: Once a day for two days.
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Reliability of the Break test
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Once a day for two days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 5, 2019
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
February 17, 2020
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
March 12, 2020
First Posted (Actual)
March 13, 2020
Study Record Updates
Last Update Posted (Actual)
March 13, 2020
Last Update Submitted That Met QC Criteria
March 12, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID 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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