Investigation of the Effect of Custom Made Insoles on Foot Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma

June 6, 2022 updated by: Özlem Feyzioğlu, Acibadem University

Investigation of the Effect of Custom Made Insoles on Foot Sole Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma

The aim of our study is to investigate the effect of the use of custom made insoles in the treatment of Morton's neuroma on foot pressure, temporal and spatial gait parameters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • 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 Backup

  • Name: Selim Muğrabi, MD

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Fulya Foot Surgery
        • Contact:

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

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of unilateral Morton neuroma
  • Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)
  • Pain level of the patients while walking is at least 3 according to the Visual Analogue Scale (VAS).
  • Volunteer to work

Exclusion Criteria:

  • Symptomatic musculoskeletal disease in the lower extremity
  • Peripheral nervous system disease
  • Presence of rigid deformity in the foot
  • Extremity or contralateral extremity surgery with Morton's neuroma

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
Intervention / Treatment
Experimental: Morton Nuroma
In patients with Morton Neuroma, stride length, stance phase percentage, swing phase percentage, cadence and speed parameters, and fore, mid and hind foot pressure distribution will be recorded with the Zebris FDM-THM-S treadmill system in the analysis of barefoot walking after the physical examination evaluation of the cases.
Other: Custom made orthosis
In patients with Morton Neuroma, stride length, stance phase percentage, swing phase percentage, cadence and speed parameters, and fore, mid and hind foot pressure distribution will be recorded with the Zebris FDM-THM-S treadmill system in the analysis of barefoot walking after the physical examination evaluation of the cases.While the treadmil is in a static state, pressure distribution measurement will be taken by baropedography, and personalized insoles will be produced according to the baropedographic pressure map. Patients will be delivered to the patient for indoor and outdoor use for 4 weeks. After a 4-week usage period, measurements related to pressure and walking parameters will be repeated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step length (centimeter- cm)
Time Frame: 4weeks
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.
4weeks
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: 4 weeks
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.
4 weeks
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
Pain - Visual Analogue Scale
Time Frame: 4 weeks
Visual Analogue Scale is one of the simple and common methods used in pain assessment. Self reported pain intensity during the rest and the activity measured by 0-10 centimeter chart. Visual Analogue Scale (VAS), where 0 indicates no pain or best and 10 indicates the most intense pain imaginable or worst. The patient will mark the severity of the pain on a 10 cm long chart.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Selim Muğrabi, MD, Fulya Foot Surgery Clinic

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)

June 1, 2022

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

September 15, 2022

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-2909

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.

Clinical Trials on Morton Neuroma

Clinical Trials on Custom made orthosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe