HealthyNCT04307758
Strength Measurement in Intrinsic Foot Muscles With Break and Make Tests
An observational study of Healthy and Adults, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Muscle Strength Assesment-Make Test and Muscle Strength Assesment-Break Test
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2019to 17 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Sedantary healthy individuals who do not have any orthopedic/neurologic lower extremity problems.
Who may be able to join
- Sedentary individuals,
- Category 1 and 2 according to the International Physical Activity Questionnaire
- Body mass index between the ranges ≥18.5 - <24.9
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Muscle Strength Assesment-Make Test, Muscle Strength Assesment-Break Test
- Keywords
- Make and Break Test, Strength assessment, Hand held dynamometer, Intrinsic foot muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Strength Assesment-Make TestOther
Also called 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 TestOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Muscle Strength Assesment-Make Test; Other: Muscle Strength Assesment-Break Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot intrinsic muscle strength with the make test
Reliability of the Make Test
Measured: Once a day for two days.
Foot intrinsic muscle strength with the break test
Reliability of the Break test
Measured: Once a day for two days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start5 Aug 2019
- Primary completion30 Dec 2019
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Yazici, Gazi University
- Investigators
- Gokhan Yazici, Pt. PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307758
- Sponsor's protocol ID
- GaziUni
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Strength Measurement in Intrinsic Foot Muscles With Break and Make Tests Using a Hand-held Dynamometer in Healthy Young Subjects
- ClinicalTrials.gov ID
- NCT04307758
- Acronym / sponsor ID
- GaziUni
- Keywords
- Make and Break Test, Strength assessment, Hand held dynamometer, Intrinsic foot muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Other: Muscle Strength Assesment-Make Test, Other: Muscle Strength Assesment-Break TestHealthy 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sedantary healthy individuals who do not have any orthopedic/neurologic lower extremity problems.
Key inclusion criteria (3 listed)
- Sedentary individuals,
- Category 1 and 2 according to the International Physical Activity Questionnaire
- Body mass index between the ranges ≥18.5 - <24.9
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Strength Assesment-Make TestAlso: Make TestFor 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 | Healthy Adults |
| Muscle Strength Assesment-Break TestAlso: Break TestFor 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 | Healthy Adults |
Primary outcome
Foot intrinsic muscle strength with the make test
Time frame: Once a day for two days.
Reliability of the Make Test
Foot intrinsic muscle strength with the break test
Time frame: Once a day for two days.
Reliability of the Break test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokhan Yazici, Pt. PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Adults, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot intrinsic muscle strength with the make test (time frame: Once a day for two days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.