NCT05012488

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

July 8, 2021

Last Update Submit

October 23, 2021

Conditions

Keywords

gaitfoot pressure

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 .

Other: Comparison of gait and foot pressure

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 .

Other: Comparison of gait and foot pressure

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.

Morton Neuroma + pes cavusMorton Neuroma + pes planus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Morton NeuromaFlatfootTalipes Cavus

Condition Hierarchy (Ancestors)

MetatarsalgiaFoot DiseasesMusculoskeletal DiseasesJoint DiseasesNeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTalipesFoot Deformities, AcquiredFoot DeformitiesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Locations