<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03787316</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK- 2018/13</org_study_id>
    <nct_id>NCT03787316</nct_id>
  </id_info>
  <brief_title>The Effects of Custom-made Insoles on Foot Pressure Redistribution and Spatio - Temporal Gait Parameters in Sever Disease</brief_title>
  <official_title>The Effects of Custom-made Insoles on Foot Pressure Redistribution and Spatio - Temporal Gait Parameters in Sever Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the effect of specially produced insoles on&#xD;
      biomechanical and gait parameters in children with Sever's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Sever's disease or calcaneal apophysitis is common in pediatric and adolescent&#xD;
      patients and characterized by heel pain. Inflammation of apophysis in children of growing age&#xD;
      causes microabrasion in bone cartilage joint. At the same time, the disease affects the&#xD;
      self-limitation and affects the maturation of calcaneus.Sever's disease is an overuse&#xD;
      syndrome and was described by James Warren Sever in 1912. The prevalence of Sever's disease&#xD;
      varies between 2% and 16%.Sever's more common in children aged 8 - 15 years, but it was&#xD;
      reported that heel pain increased during or after activity.This results in a shortening of&#xD;
      the stance phase to remove the limb to avoid heel strikes during walking. Increased tension&#xD;
      in the Achilles tendon and plantar fascia is affected by the mobility of the medial&#xD;
      longitudinal arch of the foot and increases loading on the calcaneal cartilage. Stimulates&#xD;
      foot alignment to pronation.&#xD;
&#xD;
      Different treatment have been described in Sever's disease. In the treatment program,&#xD;
      stretching, strengthening exercises and ice application are recommended especially for&#xD;
      gastrocnemius muscle and extensor muscle group.The traditional treatment approach is the&#xD;
      restriction of the child's physical activity and sporting activities and rest until the&#xD;
      symptoms have passed. In addition, orthoses can be used to treat the heel amplifier,&#xD;
      anatomical dysregulation dominated by standing pronation. There is no previous study in order&#xD;
      to investigate the effect of the specially produced insoles on the Sever's disease by&#xD;
      changing the foot pressure center and the effect of the pronation on the gait parameters.&#xD;
&#xD;
      Subjects and methods:&#xD;
&#xD;
      The study is planned to be done with physical examination and radiological imaging of the&#xD;
      patients who are between 8 and 15 years of age and diagnosed with Sever's disease. After the&#xD;
      first physical examination evaluation, the foot rotation, step length, stance phase&#xD;
      percentage, swing phase percentage, cadence and velocity parameters will be recorded with&#xD;
      Zebris FDM -T (Force Distribution Measurement Treadmill) system. Zebris is a name of company&#xD;
      in Germany.&#xD;
&#xD;
      Zebris Medical Limited ) is an innovative company that has been successful for many years in&#xD;
      the development and production of 3D motion analysis and force measurement technologies for&#xD;
      biomechanics. When the treadmill is in static and dynamic condition, strong pressure&#xD;
      distribution measurement will be taken and personalized insole production according to foot&#xD;
      pressure map will be done by orthosis prosthesis technician with Arch drafters Orthotics&#xD;
      technology. After physiotherapist,decision, it will be delivered to the patients with the&#xD;
      condition of being used outside and inside the home. Measurements related to pressure and&#xD;
      gait parameters will be repeated after 4 weeks of use and home exercise (strengthening,&#xD;
      stretching and eccentric exercise for the anterior lateral - posterior compartment of the&#xD;
      foot ).&#xD;
&#xD;
      The spatio temporal gait parameters of the patients will be evaluated with Zebris (Zebris&#xD;
      Medical Limited , Germany) FDM (Force Distribution Measurement ) treadmill system and pain&#xD;
      levels at rest and during activity will be questioned using Visual Analog Scale.&#xD;
&#xD;
      Sample size: 40 professional athlete who are between 8 and 15 years of age for experimental&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Step length (centimeter- cm)</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain - Visual Analogue Scale-</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stride length (centimeter -cm)</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step width (centimeter-cm),</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cadence (steps/min)</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>step time (second - s)</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stride time (second - s),</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Calcaneal Apophysitis</condition>
  <condition>Gait</condition>
  <condition>Sever's Disease</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Study group</intervention_name>
    <description>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.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 8-15 years&#xD;
&#xD;
          -  Calcaneal apophysitis with clinical symptoms and radiographic screening&#xD;
&#xD;
          -  Positive squeeze test sign&#xD;
&#xD;
          -  Heel pain more than 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intermittent heel pain to exclude plantar fasciitis pathology&#xD;
&#xD;
          -  Another pathology within the same or the other foot for example fracture, achilles&#xD;
             tendinitis and calcaneal bursitis&#xD;
&#xD;
          -  Another pain symptom within the other part of the extremity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fulya Foot Surgery Center</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gait</keyword>
  <keyword>sever's</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03787316
org study id: ATADEK- 2018/13
nct id: NCT03787316
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Step length (centimeter- cm)
time frame: 4 weeks
description: 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.
measure: Pain - Visual Analogue Scale-
time frame: 4 weeks
description: 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.
measure: Stride length (centimeter -cm)
time frame: 4 weeks
description: 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.
measure: Step width (centimeter-cm),
time frame: 4 weeks
description: 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.
measure: Cadence (steps/min)
time frame: 4 weeks
description: 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.
measure: step time (second - s)
time frame: 4 weeks
description: 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.
measure: Stride time (second - s),
time frame: 4 weeks
description: 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.
arm group label: Experimental group
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Study group
description: 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.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor