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Clinical Trials/NCT05411224
NCT05411224
Unknown
Not Applicable

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

Acibadem University1 site in 1 country35 target enrollmentJune 1, 2022
ConditionsMorton Neuroma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morton Neuroma
Sponsor
Acibadem University
Enrollment
35
Locations
1
Primary Endpoint
Swing phase percentage (%)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
September 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Özlem Feyzioğlu

Asistant Professor

Acibadem University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Swing phase percentage (%)

Time Frame: 4 weeks

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

Velocity

Time Frame: 4 weeks

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.

Step length (centimeter- cm)

Time Frame: 4weeks

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.

Stance phase percentage (%)

Time Frame: 4 weeks

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.

Cadance

Time Frame: 4 weeks

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.

Pain - Visual Analogue Scale

Time Frame: 4 weeks

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.

Foot pressure distiribution

Time Frame: 4 weeks

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.

Study Sites (1)

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