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

NCT05411224 | Unknown

• 1 other identifier: E-10840098-772.02-2909
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morton Neuroma

Outcome Measures

Primary Outcomes (7)

• Step length (centimeter- cm)

  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 (%)

  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.

  4 weeks

• 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

• Pain - Visual Analogue Scale

  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

Study Arms (1)

Morton Nuroma

EXPERIMENTAL

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

Interventions

Custom made orthosis OTHER

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.

Morton Nuroma

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Fulya Foot Surgery

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Morton Neuroma

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selim Muğrabi, MD

  Fulya Foot Surgery Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem Feyzioğlu, PhD

CONTACT

+902165004186; ozlem.feyzioglu@acibadem.edu.tr

Selim Muğrabi, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 15, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

TU (1)