<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20241104063588N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-06</date_registration>
      <primary_sponsor>Lincoln University College</primary_sponsor>
      <public_title>Effects of Visceral Manipulation and Kinesio Taping on Abdominal Separation, Pain, Bladder Control, Pelvic Strength, and Overall Wellness in Postpartum Women</public_title>
      <acronym>VITAL-MOMS</acronym>
      <scientific_title>Effects of Visceral Manipulation combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79954</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: all participants in the groups to which they were originally assigned, regardless of whether they completed the intervention or followed the protocol, Blinding description: double -blind experiment where participants &amp; treatment provider will be unaware of the specific treatment group to which they have been assigned. The trial will include four distinct groups to compare the effects of different treatment modalities on Diastasis Recti Abdominis (DRA) and overall well-being in postpartum women. The groups are organized as follows:.</study_design>
      <phase>1</phase>
      <hc_freetext>Diastasis Recti.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Kinesio Taping (KT) Alone. Designation: Experimental. Description: This group will receive Kinesio Taping (KT) as the sole intervention. Kinesio Tape will be applied directly to the abdominal area affected by Diastasis Recti Abdominis (DRA). The taping will be done using a crisscross pattern to provide mechanical support to the weakened abdominal muscles, aiming to decrease the Inter-Recti Distance (IRD) and alleviate associated discomfort such as lower back pain and pelvic instability. Taping will be applied by trained professionals and maintained throughout the study period, with changes and adjustments made during weekly visits over the six-week intervention period. This method is expected to improve muscle functionality and contribute to the recovery of abdominal integrity postpartum. Intervention 2: Intervention Group 2: Visceral Manipulation (VM) Alone. Designation: Experimental. Description: Participants in this group will undergo Visceral Manipulation (VM) therapy, which involves gentle manual techniques aimed at restoring the natural mobility of the internal organs and associated connective tissues. This intervention focuses on addressing the structural and functional aspects of abdominal health affected by Diastasis Recti Abdominis (DRA). The manipulation will be performed by a skilled physical therapist with expertise in visceral techniques. Treatments will occur once a week over a six-week period, with each session designed to progressively enhance organ function and support abdominal recovery. Intervention 3: Intervention Group 3: Visceral Manipulation (VM) and Kinesio Taping (KT). Designation: Experimental. Description: This group will receive a combined treatment of Visceral Manipulation (VM) and Kinesio Taping (KT). The dual approach aims to synergize the benefits of manual therapy with supportive taping. VM will address the internal dynamics of the abdominal cavity, improving organ mobility and reducing tension, while KT will provide external support to the abdominal muscles, enhancing muscle function and stability. The combination is intended to offer comprehensive treatment for DRA, potentially leading to improved outcomes in terms of abdominal muscle separation and overall postpartum recovery. Therapy sessions will be administered weekly for six weeks. Intervention 4: Intervention Group 4: Core Strengthening Exercises. Designation: Active Comparator. Description: This group, known as the Exercise group, will participate in a series of core strengthening exercises specifically tailored for postpartum rehabilitation. The exercise regimen will focus on strengthening the transverse abdominis, multifidus, pelvic floor muscles, and other core muscles critical for postpartum recovery. The exercises will be supervised by a physical therapist to ensure proper form and progression, aiming to enhance core stability and reduce IRD. Participants will engage in these exercises three times per week over a six-week period, designed to incrementally build core strength and support overall pelvic and abdominal health.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
demographics and outcomes

When:
March 2025
2 years after publication

To whom:
open access

Conditions:
open access policy

Where to obtain:
DOI number

How to obtain:
NA

Comments:
NA</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehwish Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Wisma Lincoln, No. 12-18, Jalan SS 6/12, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia</address>
        <city>Patelang Jaya</city>
        <country1>Malaysia</country1>
        <zip>47301</zip>
        <telephone>+92 307 2910332</telephone>
        <email>drduakhan@yahoo.com</email>
        <affiliation>Lincoln University College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehwish Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Wisma Lincoln, No. 12-18, Jalan SS 6/12, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia</address>
        <city>Patelang Jaya</city>
        <country1>Malaysia</country1>
        <zip>47301</zip>
        <telephone>+92 307 2910332</telephone>
        <email>drduakhan@yahoo.com</email>
        <affiliation>Lincoln University College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	DRA:  Finger width palpation shows &gt;2.5 cm
•	Postpartum females bearing at least 1 child
•	Age between 35 to 45 years old
•	Post-partum females who had gone through normal vaginal delivery, vacuum delivery, forceps delivery, and lower section caesarian section (at least 1 month after)</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>•	Any other abdominal surgery
•	Sensitivity with taping (specific for those will have KT)
•	Diagnosed with abdominal hernia
•	Open abdominal wound</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Kinesio Taping (KT) Alone. Designation: Experimental. Description: This group will receive Kinesio Taping (KT) as the sole intervention. Kinesio Tape will be applied directly to the abdominal area affected by Diastasis Recti Abdominis (DRA). The taping will be done using a crisscross pattern to provide mechanical support to the weakened abdominal muscles, aiming to decrease the Inter-Recti Distance (IRD) and alleviate associated discomfort such as lower back pain and pelvic instability. Taping will be applied by trained professionals and maintained throughout the study period, with changes and adjustments made during weekly visits over the six-week intervention period. This method is expected to improve muscle functionality and contribute to the recovery of abdominal integrity postpartum.</i_keyword>
      <i_keyword>Intervention Group 2: Visceral Manipulation (VM) Alone. Designation: Experimental. Description: Participants in this group will undergo Visceral Manipulation (VM) therapy, which involves gentle manual techniques aimed at restoring the natural mobility of the internal organs and associated connective tissues. This intervention focuses on addressing the structural and functional aspects of abdominal health affected by Diastasis Recti Abdominis (DRA). The manipulation will be performed by a skilled physical therapist with expertise in visceral techniques. Treatments will occur once a week over a six-week period, with each session designed to progressively enhance organ function and support abdominal recovery.</i_keyword>
      <i_keyword>Intervention Group 3: Visceral Manipulation (VM) and Kinesio Taping (KT). Designation: Experimental. Description: This group will receive a combined treatment of Visceral Manipulation (VM) and Kinesio Taping (KT). The dual approach aims to synergize the benefits of manual therapy with supportive taping. VM will address the internal dynamics of the abdominal cavity, improving organ mobility and reducing tension, while KT will provide external support to the abdominal muscles, enhancing muscle function and stability. The combination is intended to offer comprehensive treatment for DRA, potentially leading to improved outcomes in terms of abdominal muscle separation and overall postpartum recovery. Therapy sessions will be administered weekly for six weeks.</i_keyword>
      <i_keyword>Intervention Group 4: Core Strengthening Exercises. Designation: Active Comparator. Description: This group, known as the Exercise group, will participate in a series of core strengthening exercises specifically tailored for postpartum rehabilitation. The exercise regimen will focus on strengthening the transverse abdominis, multifidus, pelvic floor muscles, and other core muscles critical for postpartum recovery. The exercises will be supervised by a physical therapist to ensure proper form and progression, aiming to enhance core stability and reduce IRD. Participants will engage in these exercises three times per week over a six-week period, designed to incrementally build core strength and support overall pelvic and abdominal health.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PAIN. Timepoint: Before the Intervention (Baseline), 2 Weeks, 4 Weeks, 6 Weeks After the Intervention Commences. Method of measurement: viual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>NA</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-29</approval_date>
        <contact_name>Lincoln University College</contact_name>
        <contact_address>2, Jalan Stadium SS 7/15, Ss 7, 47301 Petaling Jaya, Selangor Petaling Jaya Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
