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

NCT ID: NCT03787316

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-05-30

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.

Conditions

Calcaneal Apophysitis; Gait; Sever's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

4-weeks use of specially produced shock absorbing insoles and the daily home exercise program during this 4 weeks. Daily exercises include M. gastrocnemius, soleus, tibialis anterior, tibialis posterior stretching, strengthening of the anterior, lateral, posterior compartmental and foot intrinsic muscles of the foot, eccentric exercise of gastrocnemius and soleus.

Group Type: EXPERIMENTAL

Study group

Intervention Type: 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.

Interventions

Study 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fulya Foot Surgery Center

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Feyzioglu O, Ozturk O, Mugrabi S. Effects of custom-made insoles on foot pressure redistribution, gait parameters, and pain in calcaneal apophysitis-a pretest and posttest study. Prosthet Orthot Int. 2021 Dec 1;45(6):532-537. doi: 10.1097/PXR.0000000000000039.

Reference Type: DERIVED

PMID: 34561380 (View on PubMed)

Other Identifiers

ATADEK- 2018/13

Identifier Type: -

Identifier Source: org_study_id