Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03787316
Enrollment
40
Registered
2018-12-26
Start date
2019-02-01
Completion date
2020-05-30
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcaneal Apophysitis, Gait, Sever's Disease

Keywords

gait, sever's

Brief summary

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.

Detailed description

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.

Interventions

DEVICEStudy group

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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Step length (centimeter- cm)4 weeksStep 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.
Pain - Visual Analogue Scale-4 weeksVisual 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.
Stride length (centimeter -cm)4 weeksStride 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.
Step width (centimeter-cm),4 weeksstep 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.
Cadence (steps/min)4 weeksCadence (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.
step time (second - s)4 weeksstep 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.
Stride time (second - s),4 weeksStride 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026