Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05411224
Enrollment
35
Registered
2022-06-09
Start date
2022-06-01
Completion date
2022-09-15
Last updated
2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morton Neuroma

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.

Interventions

OTHERCustom 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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Step length (centimeter- cm)4weeksStep 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.
Stance phase percentage (%)4 weeksStance 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.
Swing phase percentage (%)4 weeksSwing 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
Cadance4 weeksCadence (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.
Velocity4 weeksVelocity 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.
Foot pressure distiribution4 weeksFoot 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.
Pain - Visual Analogue Scale4 weeksVisual 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem Feyzioğlu, PhD
ozlem.feyzioglu@acibadem.edu.tr+902165004186
Backup ContactSelim Muğrabi, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026