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

NCT03787316 | Completed

• 1 other identifier: ATADEK- 2018/13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcaneal Apophysitis; Gait; Sever's Disease

Keywords

gait; sever's

Outcome Measures

Primary Outcomes (7)

• Step length (centimeter- cm)

  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.

  4 weeks

• Pain - Visual Analogue Scale-

  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.

  4 weeks

• Stride length (centimeter -cm)

  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 weeks

• Step width (centimeter-cm),

  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.

  4 weeks

• Cadence (steps/min)

  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.

  4 weeks

• step time (second - s)

  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.

  4 weeks

• Stride time (second - s),

  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.

  4 weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Device: Study group

Interventions

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.

Experimental group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Fulya Foot Surgery Center

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34561380 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 26, 2018
• Study Start: February 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 30, 2020
• Last Updated: March 25, 2021

Record last verified: 2019-02

Locations

TU (1)