Foot Positions Affect Knee and Ankle Proprioception, Balance, Vertical Jump, and Muscle Activity in Individuals With Flexible and Rigid Flatfoot and Chronic Ankle Instability

June 2, 2023 updated by: Ayman Mohamed, Beni-Suef University
To investigate the effect of various foot positions affect knee and ankle proprioception, balance, vertical jump, and muscle activity in individuals with flexible and rigid flatfoot and chronic ankle instability

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
60

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Seventy-six participants met the inclusion and exclusion of this study. These participants were screened for the type of FF. We chose 30 for each group (60 total) to accomplish the balance between groups. Group 1: 30 subjects with rigid FF and chronic ankle instability, and Group 2: 30 subjects with flexible FF and chronic ankle instability. All participants were blinded to study procedures.

Description

Inclusion Criteria:

  • The inclusion criteria were the presence of FF and chronic ankle instability in the dominant foot. Flexible and rigid flat feet were initially diagnosed by an orthopedist using a weight-bearing position with a standardized radiograph technique. The digital X-ray detector (film) and the X-ray tube (source) are 35-40 inches apart in lateral views of the foot. Then, Jack's test was performed to differentiate between the flexible and rigid FF. Jack's test is a valid test in assessing FF 10. Finally, people with flexible a second degree FF (Meary's angle between 15° to 30°) 3 were included in this study. The degree of flatfoot was determined by measuring the talus-first metatarsal angle on a lateral weight-bearing radiograph. This angle lies between a line drawn from the centers of the longitudinal axes of the talus and the first metatarsal. An angle that is greater than 4° convex downward is considered pes planus with an angle of 15° - 30° considered moderate, and greater than 30° severe 8. Chronic ankle instability was defined as the subject had a minimum of 2 acute ankle sprains, in the last 6 months, associated with pain, swelling, and a record of various ankle giving way. The determination of the dominant foot followed Vauhnik. & ark, modified version which stated that the dominant foot should be used minimally in 2 of the 3 subsequent activities: (1) Using the leg to step over a spider toy, (2) Drawing a diamond figure on the ground and (3) Kicking a ball.

Exclusion Criteria:

  • The exclusion criteria were the existence of limited hallux dorsiflexion because Jack's test is valid only if hallux dorsiflexion is available during relaxed standing. Also, the participants were excluded if they had previous hip, pelvis, knee, or foot surgeries within the last year; obesity or pregnancy; leg-length discrepancies; has any vestibular disorder neurological disorder, brain concussion within the last 3 months that may cause balance impairment; or administering any drugs that could disturb alertness or balance.

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

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.
Group 1
30 subjects with rigid flatfoot and chronic ankle instability
Other: No intervention
No intervention
Group II
30 subjects with flexible flatfoot and chronic ankle instability
Other: No intervention
No intervention

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
knee proprioception
Time Frame: 2-3 months
knee proprioception
2-3 months
ankle proprioception
Time Frame: 2-3 months
ankle proprioception
2-3 months
Vertical jump measurements
Time Frame: 2-3 months
Vertical jump measurements
2-3 months
Electromyographical activity (EMG)
Time Frame: 2-3 months
Electromyographical activity (EMG)
2-3 months

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.
Beni-Suef 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 (Estimated)

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.
July 1, 2023

Primary Completion (Estimated)

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.
October 30, 2023

Study Completion (Estimated)

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.
October 30, 2023

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).
June 2, 2023

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.
June 2, 2023

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.
June 12, 2023

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.
June 12, 2023

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.
June 2, 2023

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.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • cairo university (Other Grant/Funding Number: faculty of pedatric dentistry)

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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