Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients

Pes Planus Clinical Trial

Official title:

Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012488
• Other study ID #: ATADEK 2021- 09/58
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 5, 2021

Study information

• Verified date: October 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of our study is to compare the effect of Morton's neuroma in feet with pes planus and pes cavus on foot pressure and temporal and spatial gait parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 5, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with bilateral pes planus or pes cavus
• Diagnosis of unilateral Morton neuroma
• Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)
• Pain level of the patients during walking is at least 3 according to the Visual Analogue Scale (VAS).
• Volunteer to study over the age of 18

Exclusion Criteria:

• Having Symptomatic musculoskeletal disease in the lower extremity
• Having peripheral nervous system disease
• Presence of rigid deformity in the foot
• Extremity or contralateral extremity surgery with Morton's neuroma
• Having received physiotherapy in the last 3 months

Related Conditions & MeSH terms

• Flatfoot
• Morton Neuroma
• Neuroma
• Pes Planus

Intervention

Other:
• Comparison of gait and foot pressure
The spatio temporal gait parameters of the patients will be evaluated with Zebris (Zebris Medical Limited , Germany) FDM (Force Distribution Measurement ) treadmill system. The system has production of 3D motion analysis and force measurement technologies for biomechanics. When the treadmill is in static and dynamic condition, strong pressure distribution measurement will be taken.

Locations

Country	Name	City	State
Turkey	Fulya Foot Surgery Center	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot rotation	Foot rotation (degree), 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 to assessment the angle between the longitudinal axis of the foot and the running direction. Negative value = inward rotation, positive value = outward rotation.Subtalar joint supination describes angulation in the negative direction and pronation describes the angulation in the positive direction.Unit of measure is degrees.	4 weeks
Primary	Step length	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. Unit of measure is centimeter.	4 weeks
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.	4weeks
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
Secondary	Demographic data/patient age	The ages of the patients will be recorded in the evaluation form.	4 weeks
Secondary	Demographic data/patient weight	The weight of the patients will be recorded in the evaluation form in kilograms.	4 weeks
Secondary	Demographic data/patient height	The height of the patients will be recorded in the evaluation form in meters.	4 weeks
Secondary	Demographic data/patient body mass index BMI	The BMI of the patients will be recorded in the evaluation form in kg/m^2	4 weeks