<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/NCT04410926</url>
  </required_header>
  <id_info>
    <org_study_id>Children With Flatfeet</org_study_id>
    <nct_id>NCT04410926</nct_id>
  </id_info>
  <brief_title>Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet</brief_title>
  <official_title>Clinical And Radiological Outcomes Of Corrective Exercises With Neuromuscular Electrical Stimulation In Children And Flexible Flatfeet: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      flexible flatfoot is a common foot misalignment in children. various treatment procedures are&#xD;
      used to correct or to avoid future complain among adults and pediatric population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ethics Statement This study was approved by the Institutional Review Board of the Faculty of&#xD;
      Physical Therapy, Cairo University, Egypt (no. P.T.REC/012/0016370) and strictly adhered to&#xD;
      the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics.&#xD;
      Children's participation was commissioned by asking their legal guardian to sign a consent&#xD;
      form prior to data collection.&#xD;
&#xD;
      Study design A prospective double-masked randomized controlled trial was carried out from&#xD;
      September 1, 2018 to December 31, 2019 at the Out-patient Physical Therapy Clinic of Faculty&#xD;
      of Physical Therapy, Cairo University.&#xD;
&#xD;
      Sample size estimation Sample size calculation was performed prior to the study using G*POWER&#xD;
      statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [F tests-&#xD;
      MANOVA. Estimates of means of SAI were calculated from a preliminary study included 10&#xD;
      children who were assigned to the two treatment groups (5 children for each). Repeated&#xD;
      measures, within-between interaction, α=0.05, β=0.2, Pillai V = 0.1, and large effect size]&#xD;
      and revealed that the appropriate sample size for this study was not less than 65 children.&#xD;
      ¬then, 70 children were recruited to account for the possible dropout rates.&#xD;
&#xD;
      Randomization Seventy-two volunteer children who were recruited from governmental schools at&#xD;
      Cairo and Giza Provinces. The online Graph Pad software was used to allocate study&#xD;
      participants to either intervention group (corrective exercise and NMES) control group&#xD;
      (corrective exercise and placebo NMES). All children/legal and examiners were unaware of&#xD;
      group allocation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>
    <intervention_model_description>Intervention:&#xD;
Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).&#xD;
Neuromuscular electrical stimulation The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles. The surface electrodes were placed over the abductor halluces based on the evidence that it has the largest cross-sectional area of the intrinsic foot muscles</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Staheli's arch index</measure>
    <time_frame>period of the treatment was 4 successive months</time_frame>
    <description>The footprint is one of the easy, cost effective, noninvasive and objective measures for assessing the SAI. A value of SAI &gt;1.15 indicates flatfeet.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Navicular height</measure>
    <time_frame>period of the treatment was4 successive months</time_frame>
    <description>The navicular height was measured by the navicular drop test first described by Brody21 to evaluate the amount of foot pronation. Measurements of 6-9 mm are considered to be within the normal range. It represents the vertical extension between the most prominent point of the navicular and the supporting surface.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic indexes</measure>
    <time_frame>period of the treatment was 4 successive months</time_frame>
    <description>Radiographic indexes were carried out through bilateral radiographs encompassing horizontal (antero-posterior) and sagittal (lateral) views obtained with the child in a relaxed bipedal weight-bearing erect standing.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Sports Physical Therapy</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).&#xD;
Neuromuscular electrical stimulation The control group received placebo NMES with no current stimulation. In another words, the current intensity was set at 0mA while standing on both feet for 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).&#xD;
Neuromuscular electrical stimulation&#xD;
The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles. High-voltage pulsed current was set at frequency of 85 Hz with 5 seconds contraction time and 12 seconds rest time while the ramp-up and ramp-down time were 0.3 and 0.7 respectively. The current intensity was adjusted based on the individual tolerance without reporting pain or discomfort while standing on both feet. The stimulation time lasted each session for 30 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Corrective exercises</intervention_name>
    <description>The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuromuscular electrical stimulation</intervention_name>
    <description>The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles for 30 minutes. The surface electrodes were placed over the abductor halluces. The control group received placebo NMES with no current stimulation.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The criteria for inclusion were&#xD;
&#xD;
          -  Di¬agnosed (by an orthopedist) with asymptomatic FFF,&#xD;
&#xD;
          -  Navicular height more than 9-millimeter (mm),&#xD;
&#xD;
          -  Grade III flatfoot grade (midfoot width exceeding forefoot width)&#xD;
&#xD;
          -  Normal body weight (BMI from 5th to 85th percentile),&#xD;
&#xD;
          -  Presented with no neuromuscular or osseous anomalies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The authors excluded all children who had a history of&#xD;
&#xD;
          -  Symptomatic flatfeet&#xD;
&#xD;
          -  Congenital deformities of the lower extremities (e.g. genu valgum, femoral&#xD;
             anteversion, leg length discrepancy, hypermobile joint)&#xD;
&#xD;
          -  Scar/irri¬tated skin at the electrode placement&#xD;
&#xD;
          -  Neurological/ neuromuscular disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emam H El-Negamy</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mahmoud A Mahran</last_name>
    <role>Study Director</role>
    <affiliation>Ain shams university, Egypt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asmaa T Ramadan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>faculty of physical therapy, Cairo university</name>
      <address>
        <city>Giza</city>
        <zip>12662</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amira Mahmoud Abd-elmonem</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>Foot arch</keyword>
  <keyword>Foot print</keyword>
  <keyword>Idiopathic flexible flatfoot</keyword>
  <keyword>Navicular height</keyword>
  <keyword>Short foot exercises.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flatfoot</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04410926
org study id: Children With Flatfeet
nct id: NCT04410926
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
flexible flatfoot is a common foot misalignment in children. various treatment procedures are
      used to correct or to avoid future complain among adults and pediatric population.
Ethics Statement This study was approved by the Institutional Review Board of the Faculty of
      Physical Therapy, Cairo University, Egypt (no. P.T.REC/012/0016370) and strictly adhered to
      the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics.
      Children's participation was commissioned by asking their legal guardian to sign a consent
      form prior to data collection.

      Study design A prospective double-masked randomized controlled trial was carried out from
      September 1, 2018 to December 31, 2019 at the Out-patient Physical Therapy Clinic of Faculty
      of Physical Therapy, Cairo University.

      Sample size estimation Sample size calculation was performed prior to the study using G*POWER
      statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) [F tests-
      MANOVA. Estimates of means of SAI were calculated from a preliminary study included 10
      children who were assigned to the two treatment groups (5 children for each). Repeated
      measures, within-between interaction, α=0.05, β=0.2, Pillai V = 0.1, and large effect size]
      and revealed that the appropriate sample size for this study was not less than 65 children.
      ¬then, 70 children were recruited to account for the possible dropout rates.

      Randomization Seventy-two volunteer children who were recruited from governmental schools at
      Cairo and Giza Provinces. The online Graph Pad software was used to allocate study
      participants to either intervention group (corrective exercise and NMES) control group
      (corrective exercise and placebo NMES). All children/legal and examiners were unaware of
      group allocation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention:
Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).
Neuromuscular electrical stimulation The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles. The surface electrodes were placed over the abductor halluces based on the evidence that it has the largest cross-sectional area of the intrinsic foot muscles
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Staheli's arch index
time frame: period of the treatment was 4 successive months
description: The footprint is one of the easy, cost effective, noninvasive and objective measures for assessing the SAI. A value of SAI >1.15 indicates flatfeet.
measure: Navicular height
time frame: period of the treatment was4 successive months
description: The navicular height was measured by the navicular drop test first described by Brody21 to evaluate the amount of foot pronation. Measurements of 6-9 mm are considered to be within the normal range. It represents the vertical extension between the most prominent point of the navicular and the supporting surface.
measure: Radiographic indexes
time frame: period of the treatment was 4 successive months
description: Radiographic indexes were carried out through bilateral radiographs encompassing horizontal (antero-posterior) and sagittal (lateral) views obtained with the child in a relaxed bipedal weight-bearing erect standing.
arm group label: control group
arm group type: Placebo Comparator
description: Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).
Neuromuscular electrical stimulation The control group received placebo NMES with no current stimulation. In another words, the current intensity was set at 0mA while standing on both feet for 30 minutes.
arm group label: intervention group
arm group type: Experimental
description: Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).
Neuromuscular electrical stimulation
The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles. High-voltage pulsed current was set at frequency of 85 Hz with 5 seconds contraction time and 12 seconds rest time while the ramp-up and ramp-down time were 0.3 and 0.7 respectively. The current intensity was adjusted based on the individual tolerance without reporting pain or discomfort while standing on both feet. The stimulation time lasted each session for 30 minutes.
intervention type: Other
intervention name: Corrective exercises
description: The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes
arm group label: control group
arm group label: intervention group
intervention type: Other
intervention name: Neuromuscular electrical stimulation
description: The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles for 30 minutes. The surface electrodes were placed over the abductor halluces. The control group received placebo NMES with no current stimulation.
arm group label: intervention group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: No
last name: Emam H El-Negamy
role: Study Chair
affiliation: Cairo University
last name: Mahmoud A Mahran
role: Study Director
affiliation: Ain shams university, Egypt
last name: Asmaa T Ramadan
role: Principal Investigator
affiliation: Cairo university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amira Mahmoud Abd-elmonem
investigator title: principle investigator
mesh term: Flatfoot
sharing ipd: No