<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/NCT04453787</url>
  </required_header>
  <id_info>
    <org_study_id>YM108087F</org_study_id>
    <nct_id>NCT04453787</nct_id>
  </id_info>
  <brief_title>The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus</brief_title>
  <official_title>The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming 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>
      Forefoot varus is a type of foot deformities. It is asociate with subtalar joint&#xD;
      hyperpronation, and cause too much stress over tissues around foot and lower leg during&#xD;
      weight bearing activities.&#xD;
&#xD;
      One of the common interventions for forefoot varus is to use foot orthosis with medial&#xD;
      forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as&#xD;
      an osseus deformity and caused by insufficient talar torsion during development. However,&#xD;
      recent studies have reported forefoot varus may not be an osseus deformity. They might be a&#xD;
      result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus&#xD;
      could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for&#xD;
      osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused&#xD;
      by soft tissue adaptions, these adaptions may have a chance to reverse.&#xD;
&#xD;
      Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for&#xD;
      forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge&#xD;
      and arch support are both used in subject with forefoot varus deformity.&#xD;
&#xD;
      However, some colleges claims that using medial forefoot wedge to accommodate the deformity&#xD;
      of forefoot varus, the deformity may be fixed after a long-term period. However, there were&#xD;
      no studies compare the effect of arch support orthosis that with and without medial forefoot&#xD;
      wedge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forefoot varus is a type of foot deformities. It is asociate with subtalar joint&#xD;
      hyperpronation, and cause too much stress over tissues around foot and lower leg during&#xD;
      weight bearing activities.&#xD;
&#xD;
      One of the common interventions for forefoot varus is to use foot orthosis with medial&#xD;
      forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as&#xD;
      an osseus deformity and caused by insufficient talar torsion during development. However,&#xD;
      recent studies have reported forefoot varus may not be an osseus deformity. They might be a&#xD;
      result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus&#xD;
      could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for&#xD;
      osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused&#xD;
      by soft tissue adaptions, these adaptions may have a chance to reverse.&#xD;
&#xD;
      Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for&#xD;
      forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge&#xD;
      and arch support are both used in subject with forefoot varus deformity.&#xD;
&#xD;
      However, some colleges claims that using medial forefoot wedge to accommodate the deformity&#xD;
      of forefoot varus, the deformity may be fixed after a long-term period. However, there were&#xD;
      no studies compare the effect of arch support orthosis that with and without medial forefoot&#xD;
      wedge.&#xD;
&#xD;
      In consideration of few studies have been done for investigating the effects of different&#xD;
      orthoses in subjects with flat foot combined forefoot varus. Thus, the purpose of this study&#xD;
      is to investigate the effect of different foot orthoses designs on improving pain, muscle&#xD;
      activity and displacement of center of pressure. We hypothesized that both orthoses will have&#xD;
      the better effect on improving pain than placebo orthoses ,and muscle activity and&#xD;
      displacement of center of pressure of arch support orthoses group will have change which&#xD;
      close to normal foot.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    effected by the epidemic of COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Foot function index</measure>
    <time_frame>Baseline</time_frame>
    <description>This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Foot function index</measure>
    <time_frame>6-week intervention</time_frame>
    <description>This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain visual analogue scale (VAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain visual analogue scale (VAS)</measure>
    <time_frame>6-week intervention</time_frame>
    <description>The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Global Rating of Change Scale (GROC)</measure>
    <time_frame>change from baseline at 6 weeks later</time_frame>
    <description>To measure improvements in a patient's condition. The minimum value is -7 and it means a very great deal worse. The maximum values is +7 and it means a very great deal better.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)</measure>
    <time_frame>Baseline and after 6-week intervention</time_frame>
    <description>To determine the displacement of Cof during ambulation. We use F-Scan In-Shoe system to determine dynamic pressure, force and timing information. And to calculate the displacement of center of force of each gait cycle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis</measure>
    <time_frame>Baseline and after 6-week intervention</time_frame>
    <description>Muscle activity during ambulation and single leg standing. We use electromyography to record muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Forefoot Varus</condition>
  <condition>Flat Feet</condition>
  <arm_group>
    <arm_group_label>Arch support orthoses with forefoot medial wedge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention of this group include orthoses with arch support and added forefoot medial wedge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arch support orthoses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention of this group include orthoses with arch support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flat insole</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group will wear a flat insole. It is made from ethylene-vinyl acetate copolymer with 4mm thickness. It only provide shock absorbtion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arch support orthoses with forefoot medial wedge</intervention_name>
    <description>The degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.</description>
    <arm_group_label>Arch support orthoses with forefoot medial wedge</arm_group_label>
    <other_name>Forefoot medial wedge</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arch support orthoses</intervention_name>
    <description>The arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.</description>
    <arm_group_label>Arch support orthoses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flat insole</intervention_name>
    <description>The flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.</description>
    <arm_group_label>Flat insole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Flexible flatfoot&#xD;
&#xD;
          -  Angle of forefoot varus &gt; 6 degree&#xD;
&#xD;
          -  Feel leg or foot pain when walking or exercising, and pain visual analogue scale &gt; 3&#xD;
             points&#xD;
&#xD;
          -  The duration of wearing shoes &gt; 30 he per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rigid flatfoot&#xD;
&#xD;
          -  Leg length discrepancy &gt; 1cm&#xD;
&#xD;
          -  Angle of Hallux valgus &gt; 20 degree&#xD;
&#xD;
          -  With any nerve problem or disease&#xD;
&#xD;
          -  Used to have trauma over lower limbs&#xD;
&#xD;
          -  Had any severe joint deformity or osteoarthritis over lower limbs&#xD;
&#xD;
          -  Had any acute injury (in two weeks and inflammation)&#xD;
&#xD;
          -  Had wearing insole for 6 months&#xD;
&#xD;
          -  Can't follow order&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Fen Shih, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Physical Therapy and Assistive Technology, National Yang-Ming University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Yang Ming University</name>
      <address>
        <city>Taipei</city>
        <zip>11221</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Yi-Fen Shih</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Forefoot varus</keyword>
  <keyword>Forefoot medial wedge</keyword>
  <keyword>Flat foot</keyword>
  <keyword>Orthoses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flatfoot</mesh_term>
    <mesh_term>Metatarsus Varus</mesh_term>
  </condition_browse>
  <!-- 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/NCT04453787
org study id: YM108087F
nct id: NCT04453787
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint
      hyperpronation, and cause too much stress over tissues around foot and lower leg during
      weight bearing activities.

      One of the common interventions for forefoot varus is to use foot orthosis with medial
      forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as
      an osseus deformity and caused by insufficient talar torsion during development. However,
      recent studies have reported forefoot varus may not be an osseus deformity. They might be a
      result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus
      could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for
      osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused
      by soft tissue adaptions, these adaptions may have a chance to reverse.

      Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for
      forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge
      and arch support are both used in subject with forefoot varus deformity.

      However, some colleges claims that using medial forefoot wedge to accommodate the deformity
      of forefoot varus, the deformity may be fixed after a long-term period. However, there were
      no studies compare the effect of arch support orthosis that with and without medial forefoot
      wedge.
Forefoot varus is a type of foot deformities. It is asociate with subtalar joint
      hyperpronation, and cause too much stress over tissues around foot and lower leg during
      weight bearing activities.

      One of the common interventions for forefoot varus is to use foot orthosis with medial
      forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as
      an osseus deformity and caused by insufficient talar torsion during development. However,
      recent studies have reported forefoot varus may not be an osseus deformity. They might be a
      result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus
      could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for
      osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused
      by soft tissue adaptions, these adaptions may have a chance to reverse.

      Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for
      forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge
      and arch support are both used in subject with forefoot varus deformity.

      However, some colleges claims that using medial forefoot wedge to accommodate the deformity
      of forefoot varus, the deformity may be fixed after a long-term period. However, there were
      no studies compare the effect of arch support orthosis that with and without medial forefoot
      wedge.

      In consideration of few studies have been done for investigating the effects of different
      orthoses in subjects with flat foot combined forefoot varus. Thus, the purpose of this study
      is to investigate the effect of different foot orthoses designs on improving pain, muscle
      activity and displacement of center of pressure. We hypothesized that both orthoses will have
      the better effect on improving pain than placebo orthoses ,and muscle activity and
      displacement of center of pressure of arch support orthoses group will have change which
      close to normal foot.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Foot function index
time frame: Baseline
description: This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
measure: Foot function index
time frame: 6-week intervention
description: This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
measure: Pain visual analogue scale (VAS)
time frame: Baseline
description: The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
measure: Pain visual analogue scale (VAS)
time frame: 6-week intervention
description: The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
measure: Change From Baseline in Global Rating of Change Scale (GROC)
time frame: change from baseline at 6 weeks later
description: To measure improvements in a patient's condition. The minimum value is -7 and it means a very great deal worse. The maximum values is +7 and it means a very great deal better.
measure: Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)
time frame: Baseline and after 6-week intervention
description: To determine the displacement of Cof during ambulation. We use F-Scan In-Shoe system to determine dynamic pressure, force and timing information. And to calculate the displacement of center of force of each gait cycle.
measure: Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis
time frame: Baseline and after 6-week intervention
description: Muscle activity during ambulation and single leg standing. We use electromyography to record muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis.
arm group label: Arch support orthoses with forefoot medial wedge
arm group type: Experimental
description: The intervention of this group include orthoses with arch support and added forefoot medial wedge.
arm group label: Arch support orthoses
arm group type: Experimental
description: The intervention of this group include orthoses with arch support.
arm group label: Flat insole
arm group type: Sham Comparator
description: This group will wear a flat insole. It is made from ethylene-vinyl acetate copolymer with 4mm thickness. It only provide shock absorbtion.
intervention type: Other
intervention name: Arch support orthoses with forefoot medial wedge
description: The degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
arm group label: Arch support orthoses with forefoot medial wedge
other name: Forefoot medial wedge
intervention type: Other
intervention name: Arch support orthoses
description: The arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
arm group label: Arch support orthoses
intervention type: Other
intervention name: Flat insole
description: The flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
arm group label: Flat insole
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Yi-Fen Shih, PhD
role: Study Director
affiliation: Department of Physical Therapy and Assistive Technology, National Yang-Ming University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Yi-Fen Shih
investigator title: Professor
mesh term: Flatfoot
mesh term: Metatarsus Varus