<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/NCT04468555</url>
  </required_header>
  <id_info>
    <org_study_id>HVUJA</org_study_id>
    <nct_id>NCT04468555</nct_id>
  </id_info>
  <brief_title>Hallux Valgus Manual Therapy Based on Global Postural Reeducation.</brief_title>
  <acronym>HVMT</acronym>
  <official_title>Effects of Global Postural Reeducation on Hallux Valgus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jaén</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jaén</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>
      Manual approach of Hallux Valgus with global postural reeducation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hallux Abducto Valgus is a frequent pathology with a prevalence of 30% in women and 13% in&#xD;
      men. The tendency is to increase with age.&#xD;
&#xD;
      Usually, the elected treatment is surgery, as the conservative orthopedic methods are used at&#xD;
      the early stages of the pathology. Global Postural Re-Education is a manual therapy treatment&#xD;
      method through which we can treat lots of pathologies. Some investigations demonstrate&#xD;
      Postural Re-Education is effective for the treatment of temporomandibular disorders, urinary&#xD;
      incontinence, and spine disorders, but there is no scientific evidence that defends the&#xD;
      improvement of the symptoms and correction of the angle of the Hallux Abducto Valgus using&#xD;
      Postural Re-Education.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">February 26, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 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>
    <intervention_model_description>A single-blind randomized controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to experimental or control group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postural control</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy). There will be performed two tests: open eyes Romberg and closed eyes Romberg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dynamic balance</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle range of motion</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported instability</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>To determine the severity of ankle instability the Cumberland ankle instability tool was used. The total score of the nine items ranges from 0 (severe instability) to 30 (normal stability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the grade of hallux valgus</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>With the Manchester Scale the examiners grade the feet of the participants in: A: no hallux valgus; B: mild hallux valgus; C: moderate hallux valgus; D: severe hallux valgus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot posture</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>it will be performed the Foot Posture Index 6-items for evaluating the general foot position. It is graded as pronated, neutral or supinated depending on the punctuation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>it will be assessed by the Jack test, in which the phalangeal bone is passively dorsiflexed and the plantar arch is observed. The aim is classified the Windlass Mechanism in: intact; limited; absent. The active range of motion will be assessed by kinovea software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait parameters</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>Gait parameters after treatment with optogait system including gait cycle, contact time, flight time, and pre-swing phase during walking and running.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status</measure>
    <time_frame>From baseline to 3 weeks and 8 weeks.</time_frame>
    <description>Function in daily living and sport activities were assessed by the Foot and Ankle Ability Measure. This questionnaire Is divided by two subscales of 21 items (daily living subscale) and 8 items (sports subscale). The obtained score is expressed as a percentage calculated by dividing the patient's score by max score and the lower percentage is related to the lower level of function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hallux Valgus</condition>
  <condition>Hallux Deformity</condition>
  <condition>Foot Deformities</condition>
  <arm_group>
    <arm_group_label>Global postural reeducation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients completed 3 sessions of global postural reeducation for 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients allocated to the control group did not receive any treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Global postural reeducation</intervention_name>
    <description>It consisted of Global Postural Re-Education sessions divided into 3 sessions and performed with a frequency of 1 per week for 3 weeks. The sessions were performed individually, with an approximate duration of 40 minutes and all of them were assessed by the same physiotherapist.</description>
    <arm_group_label>Global postural reeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hallux abducto valgus with an angle between 15 - 39º&#xD;
&#xD;
          -  pain on the medial or plantar face of the forefoot&#xD;
&#xD;
          -  Physical independence to take part in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being under hallux abducto valgus treatment.&#xD;
&#xD;
          -  Lower limb surgery.&#xD;
&#xD;
          -  Fracture or disfunction on the lower limb other than hallux valgus which may affect&#xD;
             the studied variables.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Cruz-Diaz, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Jaén</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Jaen</name>
      <address>
        <city>Jaen</city>
        <zip>23071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jaén</investigator_affiliation>
    <investigator_full_name>DAVID CRUZ DÍAZ</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
    <mesh_term>Bunion</mesh_term>
    <mesh_term>Foot Deformities</mesh_term>
    <mesh_term>Foot Deformities, Congenital</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT04468555
org study id: HVUJA
nct id: NCT04468555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Manual approach of Hallux Valgus with global postural reeducation.
Hallux Abducto Valgus is a frequent pathology with a prevalence of 30% in women and 13% in
      men. The tendency is to increase with age.

      Usually, the elected treatment is surgery, as the conservative orthopedic methods are used at
      the early stages of the pathology. Global Postural Re-Education is a manual therapy treatment
      method through which we can treat lots of pathologies. Some investigations demonstrate
      Postural Re-Education is effective for the treatment of temporomandibular disorders, urinary
      incontinence, and spine disorders, but there is no scientific evidence that defends the
      improvement of the symptoms and correction of the angle of the Hallux Abducto Valgus using
      Postural Re-Education.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A single-blind randomized controlled trial.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to experimental or control group
measure: Postural control
time frame: From baseline to 3 weeks and 8 weeks.
description: Postural control was evaluated by means of a stabilometric platform of resistive pressure sensors (Sensor Medica, Rome, Italy). There will be performed two tests: open eyes Romberg and closed eyes Romberg.
measure: Dynamic balance
time frame: From baseline to 3 weeks and 8 weeks.
description: Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.
measure: Ankle range of motion
time frame: From baseline to 3 weeks and 8 weeks.
description: Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.
measure: Self-reported instability
time frame: From baseline to 3 weeks and 8 weeks.
description: To determine the severity of ankle instability the Cumberland ankle instability tool was used. The total score of the nine items ranges from 0 (severe instability) to 30 (normal stability).
measure: Assessment of the grade of hallux valgus
time frame: From baseline to 3 weeks and 8 weeks.
description: With the Manchester Scale the examiners grade the feet of the participants in: A: no hallux valgus; B: mild hallux valgus; C: moderate hallux valgus; D: severe hallux valgus.
measure: Foot posture
time frame: From baseline to 3 weeks and 8 weeks.
description: it will be performed the Foot Posture Index 6-items for evaluating the general foot position. It is graded as pronated, neutral or supinated depending on the punctuation
measure: Passive and active dorsiflexion range of motion of the 1st metatarsophalangeal joint
time frame: From baseline to 3 weeks and 8 weeks.
description: it will be assessed by the Jack test, in which the phalangeal bone is passively dorsiflexed and the plantar arch is observed. The aim is classified the Windlass Mechanism in: intact; limited; absent. The active range of motion will be assessed by kinovea software.
measure: Gait parameters
time frame: From baseline to 3 weeks and 8 weeks.
description: Gait parameters after treatment with optogait system including gait cycle, contact time, flight time, and pre-swing phase during walking and running.
measure: Functional status
time frame: From baseline to 3 weeks and 8 weeks.
description: Function in daily living and sport activities were assessed by the Foot and Ankle Ability Measure. This questionnaire Is divided by two subscales of 21 items (daily living subscale) and 8 items (sports subscale). The obtained score is expressed as a percentage calculated by dividing the patient's score by max score and the lower percentage is related to the lower level of function.
arm group label: Global postural reeducation
arm group type: Experimental
description: Patients completed 3 sessions of global postural reeducation for 3 weeks.
arm group label: Control group
arm group type: No Intervention
description: Patients allocated to the control group did not receive any treatment.
intervention type: Other
intervention name: Global postural reeducation
description: It consisted of Global Postural Re-Education sessions divided into 3 sessions and performed with a frequency of 1 per week for 3 weeks. The sessions were performed individually, with an approximate duration of 40 minutes and all of them were assessed by the same physiotherapist.
arm group label: Global postural reeducation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Cruz-Diaz, PhD
role: Study Director
affiliation: University of Jaén
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Jaén
investigator full name: DAVID CRUZ DÍAZ
investigator title: Professor
mesh term: Hallux Valgus
mesh term: Bunion
mesh term: Foot Deformities
mesh term: Foot Deformities, Congenital
mesh term: Congenital Abnormalities