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Completed

NCT Number: NCT03787316

The Effects of Custom-made Insoles on Foot Pressure Redistribution and Spatio - Temporal Gait Parameters in Sever Disease

The aim of this study was to investigate the effect of specially produced insoles on biomechanical and gait parameters in children with Sever's disease.

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Key information

Conditions

Calcaneal Apophysitis Gait Sever's Disease

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fulya Foot Surgery Center

Istanbul, Turkey (Türkiye)

About this study

Introduction: Sever's disease or calcaneal apophysitis is common in pediatric and adolescent patients and characterized by heel pain. Inflammation of apophysis in children of growing age causes microabrasion in bone cartilage joint. At the same time, the disease affects the self-limitation and affects the maturation of calcaneus.Sever's disease is an overuse syndrome and was described by James Warren Sever in 1912. The prevalence of Sever's disease varies between 2% and 16%.Sever's more common in children aged 8 - 15 years, but it was reported that heel pain increased during or after activity.This results in a shortening of the stance phase to remove the limb to avoid heel strikes during walking. Increased tension in the Achilles tendon and plantar fascia is affected by the mobility of the medial longitudinal arch of the foot and increases loading on the calcaneal cartilage. Stimulates foot alignment to pronation.

Different treatment have been described in Sever's disease. In the treatment program, stretching, strengthening exercises and ice application are recommended especially for gastrocnemius muscle and extensor muscle group.The traditional treatment approach is the restriction of the child's physical activity and sporting activities and rest until the symptoms have passed. In addition, orthoses can be used to treat the heel amplifier, anatomical dysregulation dominated by standing pronation. There is no previous study in order to investigate the effect of the specially produced insoles on the Sever's disease by changing the foot pressure center and the effect of the pronation on the gait parameters.

Subjects and methods:

The study is planned to be done with physical examination and radiological imaging of the patients who are between 8 and 15 years of age and diagnosed with Sever's disease. After the first physical examination evaluation, the foot rotation, step length, stance phase percentage, swing phase percentage, cadence and velocity parameters will be recorded with Zebris FDM -T (Force Distribution Measurement Treadmill) system. Zebris is a name of company in Germany.

Zebris Medical Limited ) is an innovative company that has been successful for many years in the development and 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 and personalized insole production according to foot pressure map will be done by orthosis prosthesis technician with Arch drafters Orthotics technology. After physiotherapist,decision, it will be delivered to the patients with the condition of being used outside and inside the home. Measurements related to pressure and gait parameters will be repeated after 4 weeks of use and home exercise (strengthening, stretching and eccentric exercise for the anterior lateral - posterior compartment of the foot ).

The spatio temporal gait parameters of the patients will be evaluated with Zebris (Zebris Medical Limited , Germany) FDM (Force Distribution Measurement ) treadmill system and pain levels at rest and during activity will be questioned using Visual Analog Scale.

Sample size: 40 professional athlete who are between 8 and 15 years of age for experimental group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 8-15 years
  • Calcaneal apophysitis with clinical symptoms and radiographic screening
  • Positive squeeze test sign
  • Heel pain more than 2 weeks

Exclusion criteria

  • Intermittent heel pain to exclude plantar fasciitis pathology
  • Another pathology within the same or the other foot for example fracture, achilles tendinitis and calcaneal bursitis
  • Another pain symptom within the other part of the extremity

Treatment and study plan

Study group

Device

4 weeks of custom-made insoles in the home and outside the home environment , follow the home exercise program during this process.It is planned to perform gait parameters and pain assessment before and after the treatment.

Primary outcomes

  1. Step length (centimeter- cm)

    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. The system is comprised of a capacitance-based pressure platform within a treadmill..When the person is standing steadily or on the walking belt, the sensors can receive reactive and normal force measurement in three dimensions with 120Hertz (Hz) frequency. Timing can be monitorized. Temporal and distance recording are taken while the patient is walking and in a static position.

  2. Pain - Visual Analogue Scale-

    Time frame: 4 weeks

    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.

  3. Stride length (centimeter -cm)

    Time frame: 4 weeks

    Stride 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. The system is comprised of a capacitance-based pressure platform within a treadmill..When the person is standing steadily or on the walking belt, the sensors can receive reactive and normal force measurement in three dimensions with 120Hertz (Hz) frequency. Timing can be monitorized. Temporal and distance recording are taken while the patient is walking and in a static position.

  4. Step width (centimeter-cm),

    Time frame: 4 weeks

    step width (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. The system is comprised of a capacitance-based pressure platform within a treadmill..When the person is standing steadily or on the walking belt, the sensors can receive reactive and normal force measurement in three dimensions with 120Hertz (Hz) frequency. Timing can be monitorized. Temporal and distance recording are taken while the patient is walking and in a static position.

  5. Cadence (steps/min)

    Time frame: 4 weeks

    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. Aim of the system analyzes gait of the patients. The system is comprised of a capacitance-based pressure platform within a treadmill..When the person is standing steadily or on the walking belt, the sensors can receive reactive and normal force measurement in three dimensions with 120Hertz (Hz) frequency. Timing can be monitorized. Temporal and distance recording are taken while the patient is walking and in a static position.

  6. step time (second - s)

    Time frame: 4 weeks

    step time ( s) 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. The system is comprised of a capacitance-based pressure platform within a treadmill..When the person is standing steadily or on the walking belt, the sensors can receive reactive and normal force measurement in three dimensions with 120Hertz (Hz) frequency. Timing can be monitorized. Temporal and distance recording are taken while the patient is walking and in a static position.

  7. Stride time (second - s),

    Time frame: 4 weeks

    Stride time (s), 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. The system is comprised of a capacitance-based pressure platform within a treadmill..When the person is standing steadily or on the walking belt, the sensors can receive reactive and normal force measurement in three dimensions with 120Hertz (Hz) frequency. Timing can be monitorized. Temporal and distance recording are taken while the patient is walking and in a static position.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2018
Registry last updated
Mar 25, 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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