<?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>IRCT20211022052835N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-18</date_registration>
      <primary_sponsor>Shifa Tameer e Millat University Islamabad</primary_sponsor>
      <public_title>Effect of task oriented functional and balance training on unsupported sitting balance in paraplegic patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of task oriented functional and balance training on unsupported sitting balance in paraplegic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61809</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: An assessor-blinded, randomised controlled trial undertaken, in which participants with &lt;6 months of spinal cord injury will be randomised to standard inpatient rehabilitation with additional task oriented training directed at improving their ability to sit unsupported. In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the patient for their participation in the study, the therapist opens the envelop and give the respective treatments to the patients (Conventional Physical Therapy or Task Oriented Training) . The study is single blinded as participants is not aware of the intervention group they are placed in, Blinding description: Prior to collecting data,  participants would be informed about both the treatments and its benefits or risks. After taking informed consent, to avoid any kind of biasness, patient is asked to pick up one envelope.  After that, the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over. The group A or B belongs to which way of treatment is known to therapist but the patient doesn't know about it. Participants are single blinded as they don't know which treatment plan or intervention is given to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>only diagnosed paraplegic patients less than 6 months of spinal cord injury having limited function in unsupported sitting task oriented functional training.</hc_freetext>
      <i_freetext>Intervention 1: experimental group (task oriented) 30 minutes per session, 3 days per week, for 8 weeks. Task oriented functional training including Picking objects from floor, Reaching for objects, retrieve objects from counter, maintain orientation and apply force through object, picking up the coins, moving objects from one side of table to another. Intervention 2: Control group: Progressive resistance training and functional strength training for 30 minutes per session, 3 days per week, for 8 weeks. Dosage for strengthening (progressive resistance training):one to three sets of 8-12 reps (rest 1-3mins between sets)2-3x per week. passive stretches, positioning in the lengthened position and other common hypertonic treatment techniques such as compression, heat and sustained deep pressure included.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer e Millat University Islamabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fouzia Batool</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 332 7120385</telephone>
        <email>fouzia_dpt.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer-e-Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 17-60 years
Both gender
ASIA scoring A &amp; B
Fire arm injury paraplegic patients (thoracic level)
Less than 6 months
Patients who are able to sit supported on wheelchair for at least 30 minutes</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having external bracing or injuries affecting their ability to lift their arms above their head.
Have an existing stage 3 or 4 sacral pressure ulcer according to the National Pressure Ulcer Advisory Panel classification
Have chronic systemic diseases, e.g. hepatitis C or HIV-AIDS
Pregnant patients
Have extensive fixed contractures in the upper limbs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G82.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Paraplegia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>experimental group (task oriented) 30 minutes per session, 3 days per week, for 8 weeks. Task oriented functional training including Picking objects from floor, Reaching for objects, retrieve objects from counter, maintain orientation and apply force through object, picking up the coins, moving objects from one side of table to another</i_keyword>
      <i_keyword>Control group: Progressive resistance training and functional strength training for 30 minutes per session, 3 days per week, for 8 weeks. Dosage for strengthening (progressive resistance training):one to three sets of 8-12 reps (rest 1-3mins between sets)2-3x per week. passive stretches, positioning in the lengthened position and other common hypertonic treatment techniques such as compression, heat and sustained deep pressure included.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance training on unsupported sitting. Timepoint: Before intervention , after 4 weeks ,and 8 weeks after intervention. Method of measurement: Sitting Balance Scale (SBS),Trunk control test, Maximal lean test, Modified Functional Reach (mFR).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention , after 4 weeks ,and 8 weeks after intervention. Method of measurement: SF 36.</sec_outcome>
      <sec_outcome>Fear of falling in unsupported sitting. Timepoint: Before intervention , after 4 weeks ,and 8 weeks after intervention. Method of measurement: SCI-FCS.</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>Shifa Tameer e Millat University Islamabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-02</approval_date>
        <contact_name>Institutional review board and ethical committee shifa tameer-e-millat and shifa international hospi</contact_name>
        <contact_address>Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad Islamabad Capital Territory Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
