Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients
1 other identifier
observational
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2021
CompletedOctober 26, 2021
October 1, 2021
2 months
July 8, 2021
October 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
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 Outcomes (4)
Demographic data/patient age
4 weeks
Demographic data/patient weight
4 weeks
Demographic data/patient height
4 weeks
Demographic data/patient body mass index BMI
4 weeks
Study Arms (2)
Morton Neuroma + pes planus
The effect of unilateral morton neuroma on gait parameters and foot pressure distribution in patients with bilateral pes planus will be investigated. Foot pressure distributions and gait parameters of the patients; foot rotation, step length, stance phase percentage, swing phase percentage, cadence, velocity, rerefoot pressure, midfoot pressure and forefoot pressure will be recorded with Zebris FDM -T ( Force distiribution Measurement Treadmill ) system. Zebris is a name of company in German .
Morton Neuroma + pes cavus
The effect of unilateral morton neuroma on gait parameters and foot pressure distribution in patients with bilateral pes cavus will be investigated. Foot pressure distributions and gait parameters of the patients; foot rotation, step length, stance phase percentage, swing phase percentage, cadence, velocity, rerefoot pressure, midfoot pressure and forefoot pressure will be recorded with Zebris FDM -T ( Force distiribution Measurement Treadmill ) system. Zebris is a name of company in German .
Interventions
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.
Eligibility Criteria
Volunteer patients older than 18 years of age with bilateral pes planus or pes cavus accompanied by Morton's neuroma will be recruited by simple randomization.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fulya Foot Surgery Center
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 8, 2021
First Posted
August 19, 2021
Study Start
July 1, 2021
Primary Completion
September 1, 2021
Study Completion
September 5, 2021
Last Updated
October 26, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share