Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients

October 23, 2021 updated by: Özlem Feyzioğlu, Acibadem University
The aim of our study is to compare the effect of Morton's neuroma in feet with pes planus and pes cavus on foot pressure and temporal and spatial gait parameters.

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.

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.
40

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

  • Turkey
      • Istanbul, Turkey
        • Fulya Foot Surgery Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Volunteer patients older than 18 years of age with bilateral pes planus or pes cavus accompanied by Morton's neuroma will be recruited by simple randomization.

Description

Inclusion Criteria:

  • Patients diagnosed with bilateral pes planus or pes cavus
  • Diagnosis of unilateral Morton neuroma
  • Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)

  • Pain level of the patients during walking is at least 3 according to the Visual Analogue Scale (VAS).

    • Volunteer to study over the age of 18

Exclusion Criteria:

  • Having Symptomatic musculoskeletal disease in the lower extremity
  • Having peripheral nervous system disease
  • Presence of rigid deformity in the foot
  • Extremity or contralateral extremity surgery with Morton's neuroma
  • Having received physiotherapy in the last 3 months

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.
Morton Neuroma + pes planus
The effect of unilateral morton neuroma on gait parameters and foot pressure distribution in patients with bilateral pes planus will be investigated. Foot pressure distributions and gait parameters of the patients; foot rotation, step length, stance phase percentage, swing phase percentage, cadence, velocity, rerefoot pressure, midfoot pressure and forefoot pressure will be recorded with Zebris FDM -T ( Force distiribution Measurement Treadmill ) system. Zebris is a name of company in German .
Other: Comparison of gait and foot pressure
The spatio temporal gait parameters of the patients will be evaluated with Zebris (Zebris Medical Limited , Germany) FDM (Force Distribution Measurement ) treadmill system. The system has production of 3D motion analysis and force measurement technologies for biomechanics. When the treadmill is in static and dynamic condition, strong pressure distribution measurement will be taken.
Morton Neuroma + pes cavus
The effect of unilateral morton neuroma on gait parameters and foot pressure distribution in patients with bilateral pes cavus will be investigated. Foot pressure distributions and gait parameters of the patients; foot rotation, step length, stance phase percentage, swing phase percentage, cadence, velocity, rerefoot pressure, midfoot pressure and forefoot pressure will be recorded with Zebris FDM -T ( Force distiribution Measurement Treadmill ) system. Zebris is a name of company in German .
Other: Comparison of gait and foot pressure
The spatio temporal gait parameters of the patients will be evaluated with Zebris (Zebris Medical Limited , Germany) FDM (Force Distribution Measurement ) treadmill system. The system has production of 3D motion analysis and force measurement technologies for biomechanics. When the treadmill is in static and dynamic condition, strong pressure distribution measurement will be taken.

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
Velocity
Time Frame: 4 weeks
Velocity will be evaluated by Zebris (Zebris Medical -Limited -, Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. The system measures average gait speed during the analyzed measuring interval. The unit is expressed as km/hr.
4 weeks
Foot pressure distiribution
Time Frame: 4 weeks
Foot pressure distiribution will be evaluated by Zebris (Zebris Medical -Limited -, Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. The system evaluate the average maximum values reached in N/cm² for the three zones: toes, mid-foot and heel.
4 weeks
Foot rotation
Time Frame: 4 weeks
Foot rotation (degree), will be evaluated by Zebris (Zebris Medical Limited - Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. Aim of the system to assessment the angle between the longitudinal axis of the foot and the running direction. Negative value = inward rotation, positive value = outward rotation.Subtalar joint supination describes angulation in the negative direction and pronation describes the angulation in the positive direction.Unit of measure is degrees.
4 weeks
Step length
Time Frame: 4 weeks
Step length (cm) will be evaluated by Zebris (Zebris Medical Limited -, Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. Aim of the system analyzes gait of the patients. Step length describes the distance between the heel contact of one side of the body and the heel contact of the contralateral side. Unit of measure is centimeter.
4 weeks
Stance phase percentage
Time Frame: 4 weeks
Stance phase percentage (%) will be evaluated by Zebris (Zebris Medical Limited -, Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. Stance phase percentage describes the phase of a gait cycle in which the foot has contact with the ground.The unit is expressed as a percentage.
4 weeks
Swing phase percentage
Time Frame: 4 weeks
Swing phase percentage (%) will be evaluated by Zebris (Zebris Medical Limited -, Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. Swing phase describes the phase of a gait cycle during which the foot has no contact with the ground. The unit is expressed as a percentage.
4 weeks
Cadance
Time Frame: 4weeks
Cadence (steps/min) will be evaluated by Zebris (Zebris Medical -Limited -, Germany) FDM (Force distribution measurement ) System. Participants will walk barefoot on the Zebris FDM (Zebris Medical Limited, Germany) treadmill system. Cadence is steps/minute. It is defined as the step frequency.
4weeks

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
Demographic data/patient age
Time Frame: 4 weeks
The ages of the patients will be recorded in the evaluation form.
4 weeks
Demographic data/patient weight
Time Frame: 4 weeks
The weight of the patients will be recorded in the evaluation form in kilograms.
4 weeks
Demographic data/patient height
Time Frame: 4 weeks
The height of the patients will be recorded in the evaluation form in meters.
4 weeks
Demographic data/patient body mass index BMI
Time Frame: 4 weeks
The BMI of the patients will be recorded in the evaluation form in kg/m^2
4 weeks

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.
Acibadem 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.
July 1, 2021

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.
September 1, 2021

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.
September 5, 2021

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 8, 2021

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.
August 12, 2021

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.
August 19, 2021

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.
October 26, 2021

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.
October 23, 2021

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.
October 1, 2021

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.
  • ATADEK 2021- 09/58

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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