<?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>IRCT20220410054476N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-11</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparative effectiveness of Maitland versus Mulligan mobilization technique for post-surgical mobility complications of distal radius fracture</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effectiveness of Maitland versus Mulligan mobilization technique for post-surgical mobility complications of distal radius fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants are allocated using simple randomization into two separate groups. The tools used in randomization are sealed envelopes, and allocation concealment was carried out. The randomization was done on an individual basis, Blinding description: The participants will be unaware in which group they will be allocated after meeting the inclusion criteria an informed consent will be taken from them by the physiotherapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>In the forearm region of upper extremity radius is the bone which is located on the lateral side of the forearm alongside ulna. The distal part of the radius is that part which is connected to the wrist. If any break or discontinuity comes in this part of the radius then it is usually referred to as fracture of the distal radius, and this fracture usually takes place when a person falls on an outstretched hand leading to impact of the wrist to the floor and resulting in fracture. This fracture can also take place if a person falls while the wrist is in a flexed position. It is also very common among people of older age and athletes. Complications such as impaired circulation, malunion, infection and complex regional pain syndrome can also occur after this fracture..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Maitland mobilization (The participants present in this group first of all received heat using hot pack for a duration of about fifteen minutes as baseline treatment. After this making sure that the muscles were completely relaxed grade 1 and grade 2 of Maitland mobilization was applied to the wrist. These two grades were applied for first two weeks. After these two weeks the level of grade was increased to grade 3 and grade 4 and these two grades of Maitland mobilization were applied for the next two weeks). Intervention 2: Intervention group 2:  Mulligan mobilization (The participants present in this group also first of all received heat using hot pack for a duration of about fifteen minutes as baseline treatment. After this making sure that the muscles were relaxed mobilization with movement technique of Mulligan mobilization was applied to the participants in the antero-posterior direction, medial direction and lateral direction at the level of the distal radio-ulnar joint. These mobilization techniques were applied for a time duration of about four weeks).</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:
All collected deidentified participant data set for the outcome measures

When:
4 months after publication

To whom:
People working in the academic institutions

Conditions:
IPD and any additional  supporting documents will be provided for research on similar topic and can be obtained by asking through the contact person mentioned below.

Where to obtain:
Contact person: Syeda Neha Asad Rizvi 
Mobile number:+92 3247797647
E-mail address: nehaasad78@gmail.com

How to obtain:
Data files will be provided after talking to the contact person mentioned above.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sidra Majeed;PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 km Sargodha road, University Town, Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 7731241</telephone>
        <email>sidra.majeed@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Syeda Neha Asad Rizvi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>14.C People's Colony No.1 Khawaja Islam Road Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 6610623</telephone>
        <email>nehaasad78@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants having distal radius fracture
Participants undergone through the process of open reduction and internal fixation
Participants whose cast has been removed after two months following surgery
Participants willing to take part in the research
Participants whose wrist mobility is restricted
Participants having pain from 3 to 7 on VAS
Participants having age from 30 to 60 years</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants gone through the procedure of close reduction for fixing the fracture
Osteopinea
Malunion of the fracture
Pre- existing inflammatory condition of the joints
Prolong steroid usage
Bony block
Hypermobility
Haemarthrosis
Sudeck’s dystrophy
Complex regional pain syndrome
Infection
Impaired sensation or circulation
Joint effusion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M84.333</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress fracture, right radius</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Maitland mobilization (The participants present in this group first of all received heat using hot pack for a duration of about fifteen minutes as baseline treatment. After this making sure that the muscles were completely relaxed grade 1 and grade 2 of Maitland mobilization was applied to the wrist. These two grades were applied for first two weeks. After these two weeks the level of grade was increased to grade 3 and grade 4 and these two grades of Maitland mobilization were applied for the next two weeks).</i_keyword>
      <i_keyword>Intervention group 2:  Mulligan mobilization (The participants present in this group also first of all received heat using hot pack for a duration of about fifteen minutes as baseline treatment. After this making sure that the muscles were relaxed mobilization with movement technique of Mulligan mobilization was applied to the participants in the antero-posterior direction, medial direction and lateral direction at the level of the distal radio-ulnar joint. These mobilization techniques were applied for a time duration of about four weeks).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain in the distal part of radius as a result of fracture is the primary outcome. Timepoint: Pain will be measured at the start of the treatment sessions and then after four weeks when the treatment sessions are finished. Method of measurement: Visual analogue scale will be used to measure pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion and functional limitation of wrist. Timepoint: Range of motion and functional limitation of wrist will be measured before the treatment sessions and after four weeks when all the treatment sessions are given. Method of measurement: Goniometer and PRWE questionnaire will be used to measure the range of motion and functional limitation.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-07</approval_date>
        <contact_name>Ethics committee of The University of Faisalabad</contact_name>
        <contact_address>4-km, Sargodha Road, University Town,Faisalabad,Pakistan Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
