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Completed

NCT Number: NCT05012488

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

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.

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Key information

Conditions

Morton Neuroma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Foot Diseases Joint Diseases Limb Deformities, Congenital Lower Extremity Deformities, Congenital Metatarsalgia Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Pes Cavus Pes Planus Signs and Symptoms Talipes Talipes Cavus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fulya Foot Surgery Center

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparison of gait and foot pressure

Other

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.

Primary outcomes

  1. Foot rotation

    Time frame: 4 weeks

    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.

  2. Step length

    Time frame: 4 weeks

    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.

  3. 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.

  4. 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.

  5. Cadance

    Time frame: 4weeks

    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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Demographic data/patient age

    Time frame: 4 weeks

    The ages of the patients will be recorded in the evaluation form.

  2. Demographic data/patient weight

    Time frame: 4 weeks

    The weight of the patients will be recorded in the evaluation form in kilograms.

  3. Demographic data/patient height

    Time frame: 4 weeks

    The height of the patients will be recorded in the evaluation form in meters.

  4. Demographic data/patient body mass index BMI

    Time frame: 4 weeks

    The BMI of the patients will be recorded in the evaluation form in kg/m^2

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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