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/NCT06026007</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/12/003363</org_study_id>
      <nct_id>NCT06026007</nct_id>
    </id_info>
    <brief_title>Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy</brief_title>
    <official_title>Efficacy of Acupressure Versus Traditional Treatment on Reducing Ankle Edema During Pregnancy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Badr University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Badr 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>
        Incidence of ankle edema is high during pregnancy, If left untreated, it may lead to&#xD;
        difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable.&#xD;
        Acupressure promotes the condition of the circulatory and lymphatic system leading to the&#xD;
        elimination of edema. The aim of this study is to investigate the efficacy of acupressure&#xD;
        versus traditional physical therapy treatment on ankle edema during pregnancy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will&#xD;
        participate in this study. They will be assigned into three equal groups, Group A will&#xD;
        receive only traditional physical therapy protocol in the form of advice including elevation,&#xD;
        wearing supportive stocking, and avoiding standing in one position for extended periods, and&#xD;
        Group B will receive the same traditional treatment as group A in addition to circulatory&#xD;
        exercises, 3times per week for 4 weeks; while Group C will receive the same conventional&#xD;
        physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 20, 2022</start_date>
    <completion_date type="Actual">May 8, 2022</completion_date>
    <primary_completion_date type="Actual">March 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>
      <intervention_model_description>Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in foot and ankle edema during pregnancy</measure>
      <time_frame>Before starting study and after four weeks of intervention</time_frame>
      <description>Foot Volumeter was used to assess foot and ankle edema</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>level of swelling</measure>
      <time_frame>Before starting study and after 4 weeks of intervention</time_frame>
      <description>Patient reported oedema Questionnaire was used to determine the level of swelling</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Gestational Edema</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patient in this group received advice only for edema relief</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Circulatory exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patient in this group received advice in addition to circulatory exercise for edema relief</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Acupressure group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patient in this group received advice in addition to acupressure for edema relief</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>advices</intervention_name>
      <description>each pregnant woman was advices how to elevate her legs and daily positions to elevate edema</description>
      <arm_group_label>Acupressure group</arm_group_label>
      <arm_group_label>Circulatory exercise group</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
      <other_name>daily advices</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional physical therapy</intervention_name>
      <description>each pregnant woman was advised about daily routine in addition to circulatory exercise</description>
      <arm_group_label>Circulatory exercise group</arm_group_label>
      <other_name>circulatory exercise</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Acupressure</intervention_name>
      <description>each pregnant woman was advised about daily routine in addition to acupressure therapy</description>
      <arm_group_label>Acupressure group</arm_group_label>
      <other_name>acupressure therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pregnant women in their third trimester,&#xD;
  &#xD;
            -  age ranged from 25-35 years and&#xD;
  &#xD;
            -  BMI was ≥30Kg/m2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women with skin diseases&#xD;
  &#xD;
            -  irremovable bracelet,&#xD;
  &#xD;
            -  decreased functional active range of motion in the affected lower extremity&#xD;
  &#xD;
            -  any mental or physical disorders.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>noha abd el rhaman, doctoral</last_name>
      <role>Principal Investigator</role>
      <affiliation>BUC</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>faculty of physical therapy Cairo university</name>
        <address>
          <city>Giza</city>
          <zip>11432</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 30, 2022</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Badr University</investigator_affiliation>
      <investigator_full_name>Noha Ahmed Fouad Abd-Elrahman</investigator_full_name>
      <investigator_title>lecturer for physical therapy for women health</investigator_title>
    </responsible_party>
    <keyword>Edema Leg</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>only data of the study will be shared</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>data will become available after publication</ipd_time_frame>
      <ipd_access_criteria>data will become available after publication</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06026007
  org study id: P.T.REC/12/003363
  nct id: NCT06026007
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Incidence of ankle edema is high during pregnancy, If left untreated, it may lead to
        difficulty walking; stiffness; stretched skin which can become itchy and uncomfortable.
        Acupressure promotes the condition of the circulatory and lymphatic system leading to the
        elimination of edema. The aim of this study is to investigate the efficacy of acupressure
        versus traditional physical therapy treatment on ankle edema during pregnancy.
  Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will
        participate in this study. They will be assigned into three equal groups, Group A will
        receive only traditional physical therapy protocol in the form of advice including elevation,
        wearing supportive stocking, and avoiding standing in one position for extended periods, and
        Group B will receive the same traditional treatment as group A in addition to circulatory
        exercises, 3times per week for 4 weeks; while Group C will receive the same conventional
        physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Sixty pregnant women aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into three equal groups, Group A will receive only traditional physical therapy protocol in the form of advice including elevation, wearing supportive stocking, and avoiding standing in one position for extended periods, and Group B will receive the same traditional treatment as group A in addition to circulatory exercises, 3times per week for 4 weeks; while Group C will receive the same conventional physical therapy protocol in addition to foot acupressure 3times per week for 4 weeks.
  primary purpose: Treatment
  masking: Single (Participant)
  measure: change in foot and ankle edema during pregnancy
  time frame: Before starting study and after four weeks of intervention
  description: Foot Volumeter was used to assess foot and ankle edema
  measure: level of swelling
  time frame: Before starting study and after 4 weeks of intervention
  description: Patient reported oedema Questionnaire was used to determine the level of swelling
  arm group label: Control group
  arm group type: Experimental
  description: patient in this group received advice only for edema relief
  arm group label: Circulatory exercise group
  arm group type: Experimental
  description: patient in this group received advice in addition to circulatory exercise for edema relief
  arm group label: Acupressure group
  arm group type: Experimental
  description: patient in this group received advice in addition to acupressure for edema relief
  intervention type: Other
  intervention name: advices
  description: each pregnant woman was advices how to elevate her legs and daily positions to elevate edema
  arm group label: Acupressure group
  arm group label: Circulatory exercise group
  arm group label: Control group
  other name: daily advices
  intervention type: Other
  intervention name: Traditional physical therapy
  description: each pregnant woman was advised about daily routine in addition to circulatory exercise
  arm group label: Circulatory exercise group
  other name: circulatory exercise
  intervention type: Other
  intervention name: Acupressure
  description: each pregnant woman was advised about daily routine in addition to acupressure therapy
  arm group label: Acupressure group
  other name: acupressure therapy
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: noha abd el rhaman, doctoral
  role: Principal Investigator
  affiliation: BUC
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Badr University
  investigator full name: Noha Ahmed Fouad Abd-Elrahman
  investigator title: lecturer for physical therapy for women health
  mesh term: Edema
  sharing ipd: Yes
  ipd description: only data of the study will be shared
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: data will become available after publication
  ipd access criteria: data will become available after publication