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Status unknownNCT05411224Updated Jun 9, 2022

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

An interventional study of Custom made orthosis in Morton Neuroma, sponsored by Acibadem University. Status unknown at 1 site in Turkey. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Acibadem University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Morton Neuroma
03

In context

Neuroma

70 studies on the registry are indexed under Neuroma; 11 are open to participants now.

This study's planned enrollment of 35 is close to the median of 33 across 49 interventional studies indexed under Neuroma.

Browse Neuroma studies →

Lead sponsor

Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4weeks

  2. 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.

    Time frame: 4 weeks

  3. 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

    Time frame: 4 weeks

  4. 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.

    Time frame: 4 weeks

  5. 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.

    Time frame: 4 weeks

  6. 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.

    Time frame: 4 weeks

  7. 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.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Fulya Foot Surgery
    Istanbul, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05411224
Lead sponsor
Acibadem University
Responsible party
Özlem Feyzioğlu (Asistant Professor, Acibadem University) — Principal investigator
First posted
Jun 9, 2022
Start date
Jun 1, 2022
Primary completion
Aug 31, 2022 (estimated)
Completion
Sep 15, 2022 (estimated)
Last update
Jun 9, 2022

Study contacts

Özlem Feyzioğlu, PhD
Contact
ozlem.feyzioglu@acibadem.edu.tr
+902165004186 ext. 4186
Selim Muğrabi, MD
Contact
Selim Muğrabi, MD
principal investigator · Fulya Foot Surgery Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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