Investigation of the Effect of Custom Made Insoles on Foot Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma
Primary Purpose
Morton Neuroma
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Custom made orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Morton Neuroma
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
Sites / Locations
- Fulya Foot SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Morton Nuroma
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05411224
Brief Title
Investigation of the Effect of Custom Made Insoles on Foot Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma
Official Title
Investigation of the Effect of Custom Made Insoles on Foot Sole Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morton Neuroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morton Nuroma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Custom made orthosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Step length (centimeter- cm)
Description
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
Title
Stance phase percentage (%)
Description
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
Title
Swing phase percentage (%)
Description
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
Title
Cadance
Description
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
Title
Velocity
Description
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
Title
Foot pressure distiribution
Description
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
Title
Pain - Visual Analogue Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem Feyzioğlu, PhD
Phone
+902165004186
Ext
4186
Email
ozlem.feyzioglu@acibadem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Selim Muğrabi, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selim Muğrabi, MD
Organizational Affiliation
Fulya Foot Surgery Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fulya Foot Surgery
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selim Muğrabi, MD
Phone
+902122401530
Email
selimmugrabi@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Effect of Custom Made Insoles on Foot Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma
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