xml: <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/NCT05996939</url>
    </required_header>
    <id_info>
      <org_study_id>UEM_LIN_2011_01</org_study_id>
      <nct_id>NCT05996939</nct_id>
    </id_info>
    <brief_title>Use of the Unstable Shoes in Lower Limb Lymphedema.</brief_title>
    <official_title>Effectiveness of Unstable Shoes on Volume and Quality of Life in Lower Limb Lymphedema.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Europea de Madrid</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Europea de Madrid</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>
        Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph&#xD;
        transport. It is defined as accumulation in the extracellular space of protein-rich fluid,&#xD;
        due to a mechanical failure of the lymphatic system. Lymphedema directly affects the quality&#xD;
        of life of the patient, not only in the physical aspect, but also in the psychological,&#xD;
        sexual and social aspects. Muscle and joint pumps are important external mechanisms of&#xD;
        lymphatic and venous fluid return improvement. The unstable shoes demands, especially during&#xD;
        standing, increased muscle activity in the lower extremities. A clinical trial was carried&#xD;
        out comparing both kinds of footwear, the objective being to evaluate possible differences in&#xD;
        the evolution of lymphedema. Unstable shoes (MBT®) were compared with conventional sports&#xD;
        shoes. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume,&#xD;
        and symptoms derived from lymphedema. The results suggested that the use of unstable shoes is&#xD;
        recommendable for walking and for long periods of standing, since it decreases leg cramping&#xD;
        and paraesthesia of affected limbs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants Subjects were recruited amongst the members of a Spanish association of people&#xD;
        affected with lymphedema. Inclusion criteria were a) Subjects affected with lower limb&#xD;
        lymphedema -primary, secondary, unilateral or bilateral-, b) Daily use of a compression&#xD;
        stocking. Exclusion criteria were a) Subjects with acute infection of the affected limb b)&#xD;
        that did not had any treatment for lymphedema one year prior to the study, c) Weight &lt;40kg,&#xD;
        d) shoe size &lt;EU35 or &gt;EU47 e)that have previously used unstable shoes f) vestibular&#xD;
        alterations, vertigo, hypoacusis c) visual compromise that affects balance.&#xD;
  &#xD;
        Procedure Written informed consent was obtained from the participants before the&#xD;
        intervention. Random allocation to experimental and control group, was performed using Excel&#xD;
        built-in function RAND ().. The generated sequence was employed to allocate the participants&#xD;
        to one of the trial groups (e.g., intervention or control). Participants followed an 8 week&#xD;
        intervention. Experimental group (EG) were provided with unstable sole shoes (MBT®, Masai&#xD;
        Barefoot Technology Spain SL,08021 Spain.) and asked to wear them following a standardized&#xD;
        protocol: 1 hour on day 1, increasing 1h each 2 days until 4h of daily use are achieved,&#xD;
        during standing position and walking in the context of daily live activities, excluding sport&#xD;
        activities. Control group (CG) was provided with a conventional sole sports footwear,&#xD;
        following the same protocol that EG.&#xD;
  &#xD;
        Outcome measures Circumferencial measure. Circumferencial measure was evaluated using a tape&#xD;
        measure to measure the circumference of the foot at different points. Distal (4 cm from the&#xD;
        base of the nail towards proximal) and Proximal (4 cm from the previous measurement).&#xD;
  &#xD;
        Volume. Kuhnke's formula was used to calculate the estimated volume of the affected limb(241)&#xD;
        V=(C12 + C22 +… Cn2)/π, Where V represents the volume and C refers to the different diameters&#xD;
        of the limb, measured in centimeters.&#xD;
  &#xD;
        Perception of the participants' clinical manifestations (243): measured through a&#xD;
        questionnaire on perception of the state of the person's vascular alteration referred to the&#xD;
        affected limb. In this survey, the subject is asked to value their symptoms (included&#xD;
        heaviness, spider veins, swelling, pain, appearance of varicose veins, cramps, paresthesia&#xD;
        and venous ulcers) with a 4-point scale: 0=absent, 1=mild/moderate, 2=important, 3=severe. In&#xD;
        addition to lower limb swelling, other important symptoms experienced are heaviness,&#xD;
        tightness, and pain. As there is no validated scale or survey to measure these symptoms&#xD;
        characteristic of lymphedema, we used as a reference a previous study [10], where the&#xD;
        symptoms or clinical manifestations compatible with chronic venous insufficiency that can be&#xD;
        extrapolated to lymphedema are described.&#xD;
  &#xD;
        In addition, a Change of habits survey was conducted at the end of the intervention period&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2013</start_date>
    <completion_date type="Actual">June 30, 2017</completion_date>
    <primary_completion_date type="Actual">June 30, 2016</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>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Volume of the lower limb</measure>
      <time_frame>8 weeks</time_frame>
      <description>Volume of the lower limb</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Circumference measure of the foot</measure>
      <time_frame>8 weeks</time_frame>
      <description>Circumference measure of the foot</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in lymphedema symptoms</measure>
      <time_frame>8 weeks</time_frame>
      <description>Changes in lymphedema symptoms</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">26</enrollment>
    <condition>Lower Limb Lymphedema</condition>
    <arm_group>
      <arm_group_label>Unstable shoes</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of unstable shoes for 8 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual sports footwear</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Use of conventional shoes for 8 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.</intervention_name>
      <description>Unstable shoes were compared with conventional sports shoes, the objective being to evaluate possible differences in the evolution of lymphedema. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema.</description>
      <arm_group_label>Unstable shoes</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -Subjects affected with lower limb lymphedema -primary, secondary, unilateral or&#xD;
          bilateral-, -Daily use of a compression stocking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with acute infection of the affected limb&#xD;
  &#xD;
            -  that did not had any treatment for lymphedema one year prior to the study,&#xD;
  &#xD;
            -  Weight &lt;40kg,&#xD;
  &#xD;
            -  shoe size &lt;EU35 or &gt;EU47&#xD;
  &#xD;
            -  that have previously used unstable shoes&#xD;
  &#xD;
            -  vestibular alterations, vertigo, hypoacusis&#xD;
  &#xD;
            -  visual compromise that affects balanc&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
      <investigator_full_name>Vanesa Abuín</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphedema</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996939
  org study id: UEM_LIN_2011_01
  nct id: NCT05996939
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph
        transport. It is defined as accumulation in the extracellular space of protein-rich fluid,
        due to a mechanical failure of the lymphatic system. Lymphedema directly affects the quality
        of life of the patient, not only in the physical aspect, but also in the psychological,
        sexual and social aspects. Muscle and joint pumps are important external mechanisms of
        lymphatic and venous fluid return improvement. The unstable shoes demands, especially during
        standing, increased muscle activity in the lower extremities. A clinical trial was carried
        out comparing both kinds of footwear, the objective being to evaluate possible differences in
        the evolution of lymphedema. Unstable shoes (MBT®) were compared with conventional sports
        shoes. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume,
        and symptoms derived from lymphedema. The results suggested that the use of unstable shoes is
        recommendable for walking and for long periods of standing, since it decreases leg cramping
        and paraesthesia of affected limbs.
  Participants Subjects were recruited amongst the members of a Spanish association of people
        affected with lymphedema. Inclusion criteria were a) Subjects affected with lower limb
        lymphedema -primary, secondary, unilateral or bilateral-, b) Daily use of a compression
        stocking. Exclusion criteria were a) Subjects with acute infection of the affected limb b)
        that did not had any treatment for lymphedema one year prior to the study, c) Weight <40kg,
        d) shoe size <EU35 or >EU47 e)that have previously used unstable shoes f) vestibular
        alterations, vertigo, hypoacusis c) visual compromise that affects balance.
  
        Procedure Written informed consent was obtained from the participants before the
        intervention. Random allocation to experimental and control group, was performed using Excel
        built-in function RAND ().. The generated sequence was employed to allocate the participants
        to one of the trial groups (e.g., intervention or control). Participants followed an 8 week
        intervention. Experimental group (EG) were provided with unstable sole shoes (MBT®, Masai
        Barefoot Technology Spain SL,08021 Spain.) and asked to wear them following a standardized
        protocol: 1 hour on day 1, increasing 1h each 2 days until 4h of daily use are achieved,
        during standing position and walking in the context of daily live activities, excluding sport
        activities. Control group (CG) was provided with a conventional sole sports footwear,
        following the same protocol that EG.
  
        Outcome measures Circumferencial measure. Circumferencial measure was evaluated using a tape
        measure to measure the circumference of the foot at different points. Distal (4 cm from the
        base of the nail towards proximal) and Proximal (4 cm from the previous measurement).
  
        Volume. Kuhnke's formula was used to calculate the estimated volume of the affected limb(241)
        V=(C12 + C22 +… Cn2)/π, Where V represents the volume and C refers to the different diameters
        of the limb, measured in centimeters.
  
        Perception of the participants' clinical manifestations (243): measured through a
        questionnaire on perception of the state of the person's vascular alteration referred to the
        affected limb. In this survey, the subject is asked to value their symptoms (included
        heaviness, spider veins, swelling, pain, appearance of varicose veins, cramps, paresthesia
        and venous ulcers) with a 4-point scale: 0=absent, 1=mild/moderate, 2=important, 3=severe. In
        addition to lower limb swelling, other important symptoms experienced are heaviness,
        tightness, and pain. As there is no validated scale or survey to measure these symptoms
        characteristic of lymphedema, we used as a reference a previous study [10], where the
        symptoms or clinical manifestations compatible with chronic venous insufficiency that can be
        extrapolated to lymphedema are described.
  
        In addition, a Change of habits survey was conducted at the end of the intervention period
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Volume of the lower limb
  time frame: 8 weeks
  description: Volume of the lower limb
  measure: Circumference measure of the foot
  time frame: 8 weeks
  description: Circumference measure of the foot
  measure: Changes in lymphedema symptoms
  time frame: 8 weeks
  description: Changes in lymphedema symptoms
  arm group label: Unstable shoes
  arm group type: Experimental
  description: Use of unstable shoes for 8 weeks
  arm group label: Usual sports footwear
  arm group type: No Intervention
  description: Use of conventional shoes for 8 weeks
  intervention type: Other
  intervention name: To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.
  description: Unstable shoes were compared with conventional sports shoes, the objective being to evaluate possible differences in the evolution of lymphedema. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema.
  arm group label: Unstable shoes
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Europea de Madrid
  investigator full name: Vanesa Abuín
  investigator title: Doctor
  mesh term: Lymphedema