Relationship Between Flexible Flat Foot and Lumbar Proprioception

March 11, 2025 updated by: Hoda Anwar Mohamed Elmeligy, Cairo University
The purpose of this study was to determine the relationship between flexible flatfoot and lumbar proprioception.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

The human foot plays a crucial role in maintaining balance during various activities, and poor foot alignment, such as excessive subtalar joint pronation, can lead to leg, knee, and back pain. Proprioception is essential for active joint stability, as it indirectly modulates and provides motor response, helping the neuromuscular system maintain balance. Lumbar proprioception deficits can decrease the ability to assume a neutral spinal posture and coordinate muscle contraction, affecting spinal segmental function, dynamic joint stability, and good motor control. This study investigates the association between flatfoot and lumbar proprioception.

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 (Actual)

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.
57

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

  • Egypt
      • Cairo, Egypt
        • out-patient clinic, faculty of physical therapy, Cairo university

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

• Subjects with flexible flat foot posture according to the Navicular Drop Test by Brody method: a normal foot (between five and nine mm of navicular drop), apronated foot (more than 10 mm of navicular drop).

Description

Inclusion Criteria:

  • 60 subjects of both sexes (females and males) were selected and assigned into two groups
  • Patient's age range was between 17 to 30 years old.
  • Subjects with flexible flat foot posture according to the Navicular Drop Test by Brody method: a normal foot (between five and nine mm of navicular drop), pronated foot (more than 10 mm of navicular drop).
  • Patients will be willing and able to participate in assessment without cognitive impairments that would limit their participation

Exclusion Criteria:

The potential participation was excluded when they had one of the following criteria:

  • Repeated lower extremity injuries, such as fractures or deformities.
  • History of surgery to the lower extremity.
  • history of back surgery
  • rheumatologic disorders
  • spine infections
  • ankle fracture
  • lumbar fracture
  • spondylosis
  • lumbar disc bulge
  • spondylolisthesis

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.
flexible flat feet
28 patients suffering from flexible flatfoot were included in this group
normal subjects
27 normal subjects were included in this group

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
assessment of the foot posture using navicular drop test
Time Frame: at baseline
The study evaluates foot posture in a weight-bearing position by placing the thumb and index fingers on the medial and lateral aspects of the talar dome. The subject is then asked to invert and evert the hind-foot and ankle until equal depressions are felt. The distance between the navicular tubercle and the floor is measured. The navicular-drop score is recorded, and the subject is classified into a pronated foot (more than 10 mm of navicular drop) and a normal foot (between five and nine mm of navicular drop).
at baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of change of lumbar proprioception using Biodex system isokinetic dynamometer
Time Frame: at baseline
The Biodex System 3 Pro isokinetic device is used to measure lumbar proprioception. The device offers isokinetic, eccentric, isometric, and passive modes for all body joints and is equipped with various attachments and isolation straps. The system is equipped with a computer unit and a special testing unit for lumbar area testing. Subjects are instructed to sit on the lumbar attachment unit with their hips and knees flexed at 90 degrees, strapped around their thigh, pelvis, and trunk, and fold their arms above their chest. The selected test is active repositioning error/speed 30o/S, with a target position of 30° lumbar flexion. The device is locked in 0° position during trials, and the isokinetic device software calculates the mean of the three real testing results. The isokinetic machine prints the results, providing each trial's error value and the average error of the three trials.
at baseline

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.
Cairo 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 (Actual)

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.
October 9, 2024

Primary Completion (Actual)

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.
January 15, 2025

Study Completion (Actual)

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.
January 22, 2025

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).
March 10, 2025

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.
March 11, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
March 11, 2025

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.
March 1, 2025

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.
  • Hoda-005289

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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