NCT04307758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 11, 2020

Last Update Submit

March 12, 2020

Conditions

Keywords

Make and Break TestStrength assessmentHand held dynamometerIntrinsic foot muscles

Outcome Measures

Primary Outcomes (2)

  • Foot intrinsic muscle strength with the make test

    Reliability of the Make Test

    Once a day for two days.

  • Foot intrinsic muscle strength with the break test

    Reliability of the Break test

    Once a day for two days.

Study Arms (1)

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 TestOther: Muscle Strength Assesment-Break Test

Interventions

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.

Also known as: Make Test
Healthy Adults

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.

Also known as: Break Test
Healthy Adults

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

Study Officials

  • Gokhan Yazici, Pt. PhD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

August 5, 2019

Primary Completion

December 30, 2019

Study Completion

February 17, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations