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

Morton Neuroma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411224
• Other study ID #: E-10840098-772.02-2909
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: June 2022
• Source: Acibadem University
• Contact: Özlem Feyzioglu, PhD
• Phone: +902165004186
• Email: ozlem.feyzioglu[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 15, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morton Neuroma
• Neuroma

Intervention

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.

Locations

Country	Name	City	State
Turkey	Fulya Foot Surgery	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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