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

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: Completed
• Conditions: Pes Planus; Morton Neuroma; Pes Cavus
• Intervention / Treatment: Other: Comparison of gait and foot pressure

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Fulya Foot Surgery Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Velocity	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	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	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	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	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	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	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

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

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 5, 2021

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: gait; foot pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Congenital Abnormalities; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Neuralgia; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Nerve Sheath Neoplasms; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Metatarsalgia; Neuroma; Flatfoot; Morton Neuroma; Talipes Cavus
• Other Study ID 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