<?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>IRCT20201220049773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-03</date_registration>
      <primary_sponsor>Riphah International University Islamabad</primary_sponsor>
      <public_title>EFFECTS OF SPINAL SEGMENTAL EXERCISES VERSUS CONVENTIONAL TREATMENT TO IMPROVE TRUNK STABILITY IN SUB ACUTE STROKE</public_title>
      <acronym></acronym>
      <scientific_title>EFFECTS OF SPINAL SEGMENTAL EXERCISES VERSUS CONVENTIONAL TREATMENT TO IMPROVE TRUNK STABILITY IN SUB ACUTE STROKE</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54543</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Lottery method, Blinding description: Participants  are blind, they don't know in which group they were allocated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sub acute stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In clinical group total 11 patients was recruited by giving training program of spinal segmental exercises for 3 sessions, 1 hour per day, during a period of 12 weeks. Without devices the bed exercises consisted of bridge exercise with legs crossed, bridge exercise, bridge exercise with one leg, side bridge exercises, curl up with straight reaching and curl up with diagonal reaching. Intervention 2: Control group: In conventional group total 11 patients was recruited by giving conventional therapy for the period of 12 week, consisting of 1 hour of treatment per day, 3 times a week for 12 weeks. Conventional exercises include Exercise 1: supine lying – Leg lifts. Exercise 2: Abdominal crunches in crook lying position. Exercise 3.Back Isometrics.</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:
Effects of spinal segmental exercises versus conventional treatment to improve trunk stability in sub acute stroke

When:
Starting 6 months after publication

To whom:
Not yet decided

Conditions:
Not yet decided

Where to obtain:
Not yet decided

How to obtain:
Not yet decided

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Misbah Waris</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 950, Block 18 fareed abad colony</address>
        <city>D.G.Khan</city>
        <country1>Pakistan</country1>
        <zip>32200</zip>
        <telephone>+92 64 2403588</telephone>
        <email>Misbah.Waris@riphah.edu.pk</email>
        <affiliation>Riphah International University Islamabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Misbah Waris</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 950, Block 18 fareed abad colony</address>
        <city>D.G.Khan</city>
        <country1>Pakistan</country1>
        <zip>32200</zip>
        <telephone>+92 64 2403588</telephone>
        <email>Misbah.Waris@riphah.edu.pk</email>
        <affiliation>Riphah International University Islamabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>a)	Patients within 1 year after onset of stroke.
b)	Age 35 to 60 years.
c)	Patients with positive sharpened Romberg test (static balance).
d)	Patients with Modified Functional reach test (Dynamic balance) specific for sub acute.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>a)	History other neurologic diseases or earlier stroke.
b)	Any incurable illness.
c)	Pain, limitation in the non-paretic lower extremity or restricted motion.
d)	Patient with cognitive disorders.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In clinical group total 11 patients was recruited by giving training program of spinal segmental exercises for 3 sessions, 1 hour per day, during a period of 12 weeks. Without devices the bed exercises consisted of bridge exercise with legs crossed, bridge exercise, bridge exercise with one leg, side bridge exercises, curl up with straight reaching and curl up with diagonal reaching</i_keyword>
      <i_keyword>Control group: In conventional group total 11 patients was recruited by giving conventional therapy for the period of 12 week, consisting of 1 hour of treatment per day, 3 times a week for 12 weeks. Conventional exercises include Exercise 1: supine lying – Leg lifts. Exercise 2: Abdominal crunches in crook lying position. Exercise 3.Back Isometrics.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To improve trunk stability in sub acute stroke patients. Timepoint: 12 weeks after intervention. Method of measurement: Trunk impairment scale and posture zone mobile app.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>None. Timepoint: none. Method of measurement: none.</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>Misbah Waris</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-27</approval_date>
        <contact_name>Secretary Ethical review committee Riphah college of rehabilitation and Allied health sciences</contact_name>
        <contact_address>House no 950, Block 18 fareed abad colony D.G.Khan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
