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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04307758
Other study ID # GaziUni
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 5, 2019
Est. completion date February 17, 2020

Study information

Verified date March 2020
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date February 17, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Foot intrinsic muscle strength with the make test Reliability of the Make Test Once a day for two days.
Primary Foot intrinsic muscle strength with the break test Reliability of the Break test Once a day for two days.
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