<?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>IRCT20230615058487N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-29</date_registration>
      <primary_sponsor>Paraplegic Center</primary_sponsor>
      <public_title>Effects of body weight supported treadmill training along with electrical stimulation on functional ambulation, pain and quality of life in patients with incomplete traumatic-spinal cord injury.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Body Weight Supported Treadmill Training along with Electrical Stimulation on Functional Ambulation, Pain and Quality Of Life in Patients with Incomplete Traumatic Spinal Cord Injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70844</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The patients were randomly assigned to three groups. The randomization process for assigning participants to these groups was performed using R software, ensuring a randomized distribution of patients among the three treatment groups. Group I: Participants in this group were designated to receive Body Weight Supported Treadmill Training (BWSTT) along with electrical stimulation (ES) in addition to conventional physical therapy. Group II: Participants in this group were assigned to receive BWSTT and conventional physical therapy. Group III: Participants in this group were assigned to receive conventional physical therapy only, Blinding description: A double-blind design was implemented to minimize bias and ensure the integrity of the research. The blinding process began with the invitation and recruitment of patients to participate in the study. During this stage, the patients were unaware of the specific treatment group they would be assigned to. The blinding will be maintained by not disclosing any information regarding the intervention groups. Following the recruitment phase, the patients were divided into their respective intervention groups, namely Group I (BWSTT + ES + conventional physical therapy), Group II (BWSTT + conventional physical therapy), and Group III (conventional physical therapy only). The allocation of patients into these groups was carried out by an independent individual not involved in the direct treatment or assessment of participants. This individual was also blinded to the nature of the interventions. The data analyst responsible for analyzing the collected data will remain unaware of the participants' group assignments and the specific treatments received by each group. This individual will be conducting the analysis without any knowledge that could potentially bias the interpretation of the results. By employing a double-blind approach, both the patients and the data analyst were kept unaware of the treatment allocations. This blinding methodology prevents potential biases from influencing the results, thereby enhancing the scientific validity and reliability of our study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spinal cord injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: This Intervention group will receive BWSTT along with electrical stimulation (ES) and conventional physical therapy. Intervention 2: Intervention group 2:This Intervention group will receive BWSTT and conventional physical therapy. Intervention 3: Control group: This control group will receive conventional physical therapy only.</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 Ethical concerns</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Amir Zeb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>2023</zip>
        <telephone>+92 42 111 747 424</telephone>
        <email>amir_zeb45@yahoo.com</email>
        <affiliation>Riphah College of Rehabilitation &amp; Allied Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Muneeb Iqbal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>2023</zip>
        <telephone>+92 42 111 747 424</telephone>
        <email>muneeb.iqbal@riphah.edu.pk</email>
        <affiliation>Riphah college of rehabilitation and allied health sciences Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged between 16-55 years
Both male and female patients
Patients with incomplete traumatic SCIs (ASIA scale B, C, D)
Patients with stable spines
Patients in the sub-acute rehabilitation phase
Patients with mild neuropathic pain (1-3 on VAS)</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients in acute phase of rehabilitation
Patients with pressure sores, infections or other complications
Patients with visual impairments that may impact participation in rehabilitation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T09.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of spinal cord, level unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: This Intervention group will receive BWSTT along with electrical stimulation (ES) and conventional physical therapy.</i_keyword>
      <i_keyword>Intervention group 2:This Intervention group will receive BWSTT and conventional physical therapy.</i_keyword>
      <i_keyword>Control group: This control group will receive conventional physical therapy only.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional ambulation. Timepoint: Before intervention and , 6 ,12 week after intervention. Method of measurement: Walking Index for Spinal Cord Injuries-II,Spinal Cord Independence Measure (SCIM),6-Minute Walk Test (6MWT) and 10-Meter Walk Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neuropathic pain level and inflammatory pain markers, and Quality Life Index for spinal cord injury. Timepoint: Before intervention and 6,12 weeks after intervention. Method of measurement: Visual Analog Scale (VAS), Neuropathic Pain Diagnostic Questionnaire along with blood tests and Quality Life Index for spinal cord injury.</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>PhD sponsorship</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-07</approval_date>
        <contact_name>Research &amp; Ethics committee of College of Rehabilitation and Allied Health Sciences(FRAHS)</contact_name>
        <contact_address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
