<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/NCT04480177</url>
  </required_header>
  <id_info>
    <org_study_id>PGS-2018-03-184</org_study_id>
    <nct_id>NCT04480177</nct_id>
  </id_info>
  <brief_title>Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects</brief_title>
  <official_title>Effect of Intrinsic Foot Muscles Training and Foot Orthosis on the Medial Longitudinal Arch in Flexible Flatfoot Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imam Abdulrahman Bin Faisal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imam Abdulrahman Bin Faisal University</source>
  <oversight_info>
    <has_dmc>No</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>
      Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat&#xD;
      foot. Little is known about the effectiveness of their interaction on managing flatfoot.&#xD;
&#xD;
      The study aims to evaluate the effect of insoles and short foot exercise on the height and&#xD;
      area of the medial longitudinal arch of flexible flatfoot participants as well as the force&#xD;
      and pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: A parallel, active-control study design was used to conduct a single-blinded&#xD;
      randomized controlled trial.&#xD;
&#xD;
      Method: The toe rising test, the &quot;too many toes&quot; sign, and the navicular drop test was used&#xD;
      to select 30 participants with flexible flatfoot. Participants was randomly assigned either&#xD;
      to an experimental group (n = 15) or a control group (n = 15). The experimental group&#xD;
      received short foot exercises (SFE) and insoles, and the control group received only insoles.&#xD;
      SFE was implemented 30 times for a duration of three minutes each day over the course of six&#xD;
      weeks. The exercise progressed from sitting to standing and finally to one leg stance&#xD;
      position within every two weeks. The participants wore shoes containing orthotic insoles for&#xD;
      eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure&#xD;
      distribution (force, area, and pressure) at baseline and at two-week intervals throughout the&#xD;
      six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate&#xD;
      restriction in participants' functional abilities, and the navicular drop test (NDT) was used&#xD;
      to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline&#xD;
      and at the sixth week.&#xD;
&#xD;
      Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two&#xD;
      groups across time and within-subject observations of the outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2018</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The EMED (force-area-pressure)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lower extremities functional scale, navicular drop test</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Flexible Flatfoot</condition>
  <arm_group>
    <arm_group_label>insole group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the control group receives insole only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the experimental group receives exercise and insole.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>foot insole</intervention_name>
    <description>the subject was instructed to wear foot insole for 8 hours.</description>
    <arm_group_label>exercise group</arm_group_label>
    <arm_group_label>insole group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>short foot exercise</intervention_name>
    <description>the subject was instructed to perform exercise once a day 30 repetitions.</description>
    <arm_group_label>exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females and males aged between 18 and 36&#xD;
&#xD;
          -  Bilateral symptomatic flexible flatfoot, with symptoms including foot pain and lower&#xD;
             limb fatigue&#xD;
&#xD;
          -  Participants must show positive physical examination findings, including a positive&#xD;
             result for the &quot;too many toes&quot; sign, the navicular drop test, and the foot toe raising&#xD;
             test (Carr et al., 2016). A positive result for the &quot;too many toes&quot; sign occurs when&#xD;
             more toes can be seen on the lateral side of each foot due to external rotation and&#xD;
             abduction of the feet, and the positive result for the toe rising test is the&#xD;
             reconstruction of the medial longitudinal arch secondary to the tightness of the&#xD;
             plantar fascia (Carr et al., 2016). A positive result for the navicular drop test is&#xD;
             an arch height more than or equal to 10 mm(Aenumulapalli et al., 2017)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An anatomical discrepancy in leg length&#xD;
&#xD;
          -  Pathologic or neurologic disorders of the feet&#xD;
&#xD;
          -  A history of traumatic foot injury or surgery within the last six months&#xD;
&#xD;
          -  History of wearing foot orthoses within the past two years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Imam Abdulrahman Bin Faisal University</name>
      <address>
        <city>Dammam</city>
        <state>Eastren</state>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Abdel-Fattah, M.M., Hassanin, M.M., Felembane, F.A., Nassaane, M.T., 2006. Flat foot among Saudi Arabian army recruits: prevalence and risk factors. East. Mediterr. Health J. Rev. Sante Mediterr. Orient. Al-Majallah Al-Sihhiyah Li-Sharq Al-Mutawassit 12, 211-217. Abousayed, M.M., Tartaglione, J.P., Rosenbaum, A.J., Dipreta, J.A., 2016. Classifications in Brief: Johnson and Strom Classification of Adult-acquired Flatfoot Deformity. Clin. Orthop. 474, 588-593. Aenumulapalli, A., Kulkarni, M.M., Gandotra, A.R., 2017. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J. Clin. Diagn. Res. JCDR 11, AC17-AC20. Allen, M.K., Glasoe, W.M., 2000. Metrecom Measurement of Navicular Drop in Subjects with Anterior Cruciate Ligament Injury. J. Athl. Train. 35, 403-406. Alnahdi, A.H., Alrashid, G.I., Alkhaldi, H.A., Aldali, A.Z., 2016. Cross-cultural adaptation, validity and reliability of the Arabic version of the Lower Extremity Functional Scale. Disabil. Rehabil. 38, 897-904. Aminian, G., Safaeepour, Z., Farhoodi, M., Pezeshk, A.F., Saeedi, H., Majddoleslam, B., 2013. The effect of prefabricated and proprioceptive foot orthoses on plantar pressure distribution in patients with flexible flatfoot during walking. Prosthet. Orthot. Int. 37, 227-232. Banwell, H.A., Mackintosh, S., Thewlis, D., 2014. Foot orthoses for adults with flexible pes planus: a systematic review. J. Foot Ankle Res. 7, 23. Buldt, A.K., Forghany, S., Landorf, K.B., Levinger, P., Murley, G.S., Menz, H.B., 2018. Foot posture is associated with plantar pressure during gait: A comparison of normal, planus and cavus feet. Gait Posture 62, 235-240. https://doi.org/10.1016/j.gaitpost.2018.03.005 Carr, J.B., Yang, S., Lather, L.A., 2016. Pediatric Pes Planus: A State-of-the-Art Review. Pediatrics 137, e20151230. Chen, Y.-C., Lou, S.-Z., Huang, C.-Y., Su, F.-C., 2010. Effects of foot orthoses on gait patterns of flat feet patients. Clin. Biomech. Bristol Avon 25, 265-270. Cheng, Y., Yang, H., Ni, L., Song, D., Zhang, H., 2015. Stress fracture of the distal fibula in flatfoot patients: case report. Int. J. Clin. Exp. Med. 8, 6303-6307. Chuter, V., Spink, M., Searle, A., Ho, A., 2014. The effectiveness of shoe insoles for the prevention and treatment of low back pain: a systematic review and meta-analysis of randomised controlled trials. BMC Musculoskelet. Disord. 15, 140. https://doi.org/10.1186/1471-2474-15-140 Daniels, T.R., Lau, J.T., Hearn, T.C., 1998. The effects of foot position and load on tibial nerve tension. Foot Ankle Int. 19, 73-78. https://doi.org/10.1177/107110079801900204 Dars, S., Uden, H., Kumar, S., Banwell, H.A., 2018. When, why and how foot orthoses (FOs) should be prescribed for children with flexible pes planus: a Delphi survey of podiatrists. PeerJ 6, e4667. https://doi.org/10.7717/peerj.4667 Giacomozzi, C., 2010. Appropriateness of plantar pressure measurement devices: A comparative technical assessment. Gait Posture 32, 141-144. https://doi.org/10.1016/j.gaitpost.2010.03.014 Hafer, J.F., Lenhoff, M.W., Song, J., Jordan, J.M., Hannan, M.T., Hillstrom, H.J., 2013. Reliability of plantar pressure platforms. Gait Posture 38, 544-548. https://doi.org/10.1016/j.gaitpost.2013.01.028 Hatfield, G.L., Cochrane, C.K., Takacs, J., Krowchuk, N.M., Chang, R., Hinman, R.S., Hunt, M.A., 2016. Knee and ankle biomechanics with lateral wedges with and without a custom arch support in those with medial knee osteoarthritis and flat feet. J. Orthop. Res. Off. Publ. Orthop. Res. Soc. 34, 1597-1605. https://doi.org/10.1002/jor.23174 Hegedus, E.J., Cook, C., Fiander, C., Wright, A., 2010. Measures of arch height and their relationship to pain and dysfunction in people with lower limb impairments. Physiother. Res. Int. 15, 160-166. https://doi.org/10.1002/pri.459 Hsieh, R.-L., Peng, H.-L., Lee, W.-C., 2018. Short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children: A randomized controlled trial. Medicine (Baltimore) 97, e10655. https://doi.org/10.1097/MD.0000000000010655 Huang, Y.-C., Wang, L.-Y., Wang, H.-C., Chang, K.-L., Leong, C.-P., 2004. The relationship between the flexible flatfoot and plantar fasciitis: ultrasonographic evaluation. Chang Gung Med. J. 27, 443-448. Imhauser, C.W., Abidi, N.A., Frankel, D.Z., Gavin, K., Siegler, S., 2002. Biomechanical evaluation of the efficacy of external stabilizers in the conservative treatment of acquired flatfoot deformity. Foot Ankle Int. 23, 727-737.</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Imam Abdulrahman Bin Faisal University</investigator_affiliation>
    <investigator_full_name>Shaikha Uthman</investigator_full_name>
    <investigator_title>master student</investigator_title>
  </responsible_party>
  <keyword>Flatfoot</keyword>
  <keyword>Insole</keyword>
  <keyword>Short-foot exercise</keyword>
  <keyword>Orthotic</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/NCT04480177
org study id: PGS-2018-03-184
nct id: NCT04480177
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat
      foot. Little is known about the effectiveness of their interaction on managing flatfoot.

      The study aims to evaluate the effect of insoles and short foot exercise on the height and
      area of the medial longitudinal arch of flexible flatfoot participants as well as the force
      and pressure.
Study design: A parallel, active-control study design was used to conduct a single-blinded
      randomized controlled trial.

      Method: The toe rising test, the "too many toes" sign, and the navicular drop test was used
      to select 30 participants with flexible flatfoot. Participants was randomly assigned either
      to an experimental group (n = 15) or a control group (n = 15). The experimental group
      received short foot exercises (SFE) and insoles, and the control group received only insoles.
      SFE was implemented 30 times for a duration of three minutes each day over the course of six
      weeks. The exercise progressed from sitting to standing and finally to one leg stance
      position within every two weeks. The participants wore shoes containing orthotic insoles for
      eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure
      distribution (force, area, and pressure) at baseline and at two-week intervals throughout the
      six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate
      restriction in participants' functional abilities, and the navicular drop test (NDT) was used
      to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline
      and at the sixth week.

      Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two
      groups across time and within-subject observations of the outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The EMED (force-area-pressure)
time frame: 6 weeks
description: The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.
measure: Lower extremities functional scale, navicular drop test
time frame: 6 weeks
description: The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week.
arm group label: insole group
arm group type: Other
description: the control group receives insole only.
arm group label: exercise group
arm group type: Experimental
description: the experimental group receives exercise and insole.
intervention type: Device
intervention name: foot insole
description: the subject was instructed to wear foot insole for 8 hours.
arm group label: exercise group
arm group label: insole group
intervention type: Other
intervention name: short foot exercise
description: the subject was instructed to perform exercise once a day 30 repetitions.
arm group label: exercise group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 36 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
citation: Abdel-Fattah, M.M., Hassanin, M.M., Felembane, F.A., Nassaane, M.T., 2006. Flat foot among Saudi Arabian army recruits: prevalence and risk factors. East. Mediterr. Health J. Rev. Sante Mediterr. Orient. Al-Majallah Al-Sihhiyah Li-Sharq Al-Mutawassit 12, 211-217. Abousayed, M.M., Tartaglione, J.P., Rosenbaum, A.J., Dipreta, J.A., 2016. Classifications in Brief: Johnson and Strom Classification of Adult-acquired Flatfoot Deformity. Clin. Orthop. 474, 588-593. Aenumulapalli, A., Kulkarni, M.M., Gandotra, A.R., 2017. Prevalence of Flexible Flat Foot in Adults: A Cross-sectional Study. J. Clin. Diagn. Res. JCDR 11, AC17-AC20. Allen, M.K., Glasoe, W.M., 2000. Metrecom Measurement of Navicular Drop in Subjects with Anterior Cruciate Ligament Injury. J. Athl. Train. 35, 403-406. Alnahdi, A.H., Alrashid, G.I., Alkhaldi, H.A., Aldali, A.Z., 2016. Cross-cultural adaptation, validity and reliability of the Arabic version of the Lower Extremity Functional Scale. Disabil. Rehabil. 38, 897-904. Aminian, G., Safaeepour, Z., Farhoodi, M., Pezeshk, A.F., Saeedi, H., Majddoleslam, B., 2013. The effect of prefabricated and proprioceptive foot orthoses on plantar pressure distribution in patients with flexible flatfoot during walking. Prosthet. Orthot. Int. 37, 227-232. Banwell, H.A., Mackintosh, S., Thewlis, D., 2014. Foot orthoses for adults with flexible pes planus: a systematic review. J. Foot Ankle Res. 7, 23. Buldt, A.K., Forghany, S., Landorf, K.B., Levinger, P., Murley, G.S., Menz, H.B., 2018. Foot posture is associated with plantar pressure during gait: A comparison of normal, planus and cavus feet. Gait Posture 62, 235-240. https://doi.org/10.1016/j.gaitpost.2018.03.005 Carr, J.B., Yang, S., Lather, L.A., 2016. Pediatric Pes Planus: A State-of-the-Art Review. Pediatrics 137, e20151230. Chen, Y.-C., Lou, S.-Z., Huang, C.-Y., Su, F.-C., 2010. Effects of foot orthoses on gait patterns of flat feet patients. Clin. Biomech. Bristol Avon 25, 265-270. Cheng, Y., Yang, H., Ni, L., Song, D., Zhang, H., 2015. Stress fracture of the distal fibula in flatfoot patients: case report. Int. J. Clin. Exp. Med. 8, 6303-6307. Chuter, V., Spink, M., Searle, A., Ho, A., 2014. The effectiveness of shoe insoles for the prevention and treatment of low back pain: a systematic review and meta-analysis of randomised controlled trials. BMC Musculoskelet. Disord. 15, 140. https://doi.org/10.1186/1471-2474-15-140 Daniels, T.R., Lau, J.T., Hearn, T.C., 1998. The effects of foot position and load on tibial nerve tension. Foot Ankle Int. 19, 73-78. https://doi.org/10.1177/107110079801900204 Dars, S., Uden, H., Kumar, S., Banwell, H.A., 2018. When, why and how foot orthoses (FOs) should be prescribed for children with flexible pes planus: a Delphi survey of podiatrists. PeerJ 6, e4667. https://doi.org/10.7717/peerj.4667 Giacomozzi, C., 2010. Appropriateness of plantar pressure measurement devices: A comparative technical assessment. Gait Posture 32, 141-144. https://doi.org/10.1016/j.gaitpost.2010.03.014 Hafer, J.F., Lenhoff, M.W., Song, J., Jordan, J.M., Hannan, M.T., Hillstrom, H.J., 2013. Reliability of plantar pressure platforms. Gait Posture 38, 544-548. https://doi.org/10.1016/j.gaitpost.2013.01.028 Hatfield, G.L., Cochrane, C.K., Takacs, J., Krowchuk, N.M., Chang, R., Hinman, R.S., Hunt, M.A., 2016. Knee and ankle biomechanics with lateral wedges with and without a custom arch support in those with medial knee osteoarthritis and flat feet. J. Orthop. Res. Off. Publ. Orthop. Res. Soc. 34, 1597-1605. https://doi.org/10.1002/jor.23174 Hegedus, E.J., Cook, C., Fiander, C., Wright, A., 2010. Measures of arch height and their relationship to pain and dysfunction in people with lower limb impairments. Physiother. Res. Int. 15, 160-166. https://doi.org/10.1002/pri.459 Hsieh, R.-L., Peng, H.-L., Lee, W.-C., 2018. Short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children: A randomized controlled trial. Medicine (Baltimore) 97, e10655. https://doi.org/10.1097/MD.0000000000010655 Huang, Y.-C., Wang, L.-Y., Wang, H.-C., Chang, K.-L., Leong, C.-P., 2004. The relationship between the flexible flatfoot and plantar fasciitis: ultrasonographic evaluation. Chang Gung Med. J. 27, 443-448. Imhauser, C.W., Abidi, N.A., Frankel, D.Z., Gavin, K., Siegler, S., 2002. Biomechanical evaluation of the efficacy of external stabilizers in the conservative treatment of acquired flatfoot deformity. Foot Ankle Int. 23, 727-737.
responsible party type: Principal Investigator
investigator affiliation: Imam Abdulrahman Bin Faisal University
investigator full name: Shaikha Uthman
investigator title: master student
mesh term: Flatfoot
sharing ipd: No