Balance Effects of Morton´s Extension in Flat Foot

August 6, 2024 updated by: EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic

Balance Effects of Morton´s Extension in Flat Foot. A Pre-post-test Study.

The aim of this study is to simulate the orthopedic treatment called Morton's extension on flat foot patients to check balance effects in standing position.

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.

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.

Detailed Description

The objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on flat foot patients to verify the balance with stabilometry study.

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.
Interventional

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.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eva María Martínez Jiménez, PhD
  • Phone Number: (+34) 616255378
  • Email: evamam03@ucm.es

Study Locations

  • Spain
      • León, Spain, 24401
        • Eva María Martínez-Jiménez

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

Yes

Description

Inclusion Criteria:

  • Women and men aged 18 to 30 with flexible flat feet.

Exclusion Criteria:

  • Participants who have had any previous limb surgery, and/or previous lower limb trauma within the last year
  • Uncorrected hearing or visual impairment.
  • Lumbar pathology with radicular involvement.
  • Pregnancy.
  • Healthy participants performing strenuous exercise.
  • Diagnosed active or inactive rheumatic or inflammatory disease.
  • Participants consuming alcohol within 24 hours prior to recording or stimulants 6 hours prior to testing (e.g. caffeine).
  • Participants who have a history of injury with residual lower extremity symptoms within the past year.
  • Participants with evidence of a leg length discrepancy (difference in distance from the anterior superior iliac spine to the superior iliac spine at the surface of the most prominent aspect of the medial malleolus) of more than 1 cm 19
  • Having at least 15 degrees of ankle dorsiflexion.
  • Participants with evidence of balance deficit, as determined through oral questioning about falls and by use of the Balance Evaluation Systems Test (BESTest).
  • Participants with neurological pathology with lower limb deformities, sensory-motor disturbances, neuromuscular pathology, or neurovascular disease.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Morton.s extension treatment
Appliation of Morton´s extension treatment simulation
Other: Morton extension
A Morton extension with a height of 5 mm was insert from the proximal area of the first metatarsal head to the base of the proximal phalanx of the Hallux of the subjects' bare feet using a paper bandage. The material, shape, size, and thickness of the Morton Extension were the same.

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
Length in millimetres of the centre of pressures. Untreated
Time Frame: Through study completion, an average of 4 days
Length of the centre of pressures described in millimetres.
Through study completion, an average of 4 days
Area of the ellipse. Untreated
Time Frame: Through study completion, an average of 4 days
Area of the ellipse in square millimeters.
Through study completion, an average of 4 days
Inclination of the ellipse in degrees.Untreated
Time Frame: Through study completion, an average of 4 days
Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.
Through study completion, an average of 4 days
Length-area ratio. Untreated
Time Frame: Through study completion, an average of 4 days
Fraction of the length of the ellipse between the surface of the ellipse in millimetres.
Through study completion, an average of 4 days
Delta x. Untreated
Time Frame: Through study completion, an average of 4 days
Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.
Through study completion, an average of 4 days
Delta y. Untreated
Time Frame: Through study completion, an average of 4 days
Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.
Through study completion, an average of 4 days
Displacement on the major axis or y-axis. Untreated
Time Frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Through study completion, an average of 4 days
Displacement on the minor axis or x-axis. Untreated
Time Frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Through study completion, an average of 4 days
Maximum oscillation. Untreated
Time Frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the maximum oscillations.
Through study completion, an average of 4 days
Minimum oscillation in millimetres. Untreated
Time Frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the minimum oscillations
Through study completion, an average of 4 days
Length in millimetres of the centre of pressures with treatment
Time Frame: Through study completion, an average of 4 days
Length of the centre of pressures described in millimetres.
Through study completion, an average of 4 days
Area of the ellipse with treatment
Time Frame: Through study completion, an average of 4 days
Area of the ellipse in square millimeters.
Through study completion, an average of 4 days
Inclination of the ellipse in degrees with treatment
Time Frame: Through study completion, an average of 4 days
Inclination of the ellipse generated by the centre of pressures in 30 seconds in degrees.
Through study completion, an average of 4 days
Length-area ratio with treatment
Time Frame: Through study completion, an average of 4 days
Fraction of the length of the ellipse between the surface of the ellipse in millimetres.
Through study completion, an average of 4 days
Delta x with treatment
Time Frame: Through study completion, an average of 4 days
Displacement on the x-axis within the ellipse calculated from the movements of the barycentre. In millimetres.
Through study completion, an average of 4 days
Delta y with treatment
Time Frame: Through study completion, an average of 4 days
Displacement on the y-axis within the ellipse calculated based on the movements of the barycentre. In millimetres.
Through study completion, an average of 4 days
Displacement on the major axis or y-axis with treatment
Time Frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Through study completion, an average of 4 days
Displacement on the minor axis or x-axis with treatment
Time Frame: Through study completion, an average of 4 days
Displacement in millimetres of the y-axis.
Through study completion, an average of 4 days
Maximum oscillation with treatment
Time Frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the maximum oscillations.
Through study completion, an average of 4 days
Minimum oscillation in millimetres with treatment
Time Frame: Through study completion, an average of 4 days
Measurement of the length in millimetres of the minimum oscillations
Through study completion, an average of 4 days

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.
Mayuben Private Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de León

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva María Martínez Jiménez, PhD, Universidad Complutense de Madrid

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.
July 30, 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.
August 5, 2024

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.
August 6, 2024

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).
July 24, 2024

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.
July 24, 2024

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.
July 30, 2024

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.
August 7, 2024

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.
August 6, 2024

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.
August 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 24/458-E

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings