<?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>IRCT20200330046895N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-19</date_registration>
      <primary_sponsor>The University Of Lahore</primary_sponsor>
      <public_title>EFFECTS OF VIRTUAL REALITY EXERCISES ON CLINICAL OUTCOMES IN PATIENTS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL</public_title>
      <acronym></acronym>
      <scientific_title>EFFECTS OF VIRTUAL REALITY EXERCISES ON CLINICAL OUTCOMES IN PATIENTS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46916</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects fulfilling the inclusion criteria will be enrolled after independent outcome assessor Then coin toss method will be used for randomization .The coin will be thrown in air having two sides with label "A" and "B".  The subject's randomization method reduces the chances of bias group allocation, Blinding description: The study would be single blinded as assessor of the study will be kept blind of the treatment group to which the pateint will be alloacated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Low back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will get Virtual reality exercises. The Kinect device will be used for Virtual Reality (VR) Exercises in which patient will perform exercises through reflex ridge VR game which includes trunk slide flexion, jumping, sitting to avoid hitting the obstacles and combine movement of legs and arms 5 minutes as displayed on wall mounted LCD, then after 30 seconds rest patient will perform exercises through Body Ball VR game which includes moving arm, pushing head and kicking the ball for 5 minutes. Prior to VR exercise thermotherapy through hot pack for 10 minutes will be applied on Lumbar region. In addition to VR exercise patients will get routine physical therapy which includes patient education ,posture care  and exercises as three sets of 10 repetition of  bridging, prone leg raises, trunk extension in prone with arms behind the back, trunk rotation exercises, knee to chest and prone position with diagonal elevation of the arm and leg exercise. This will be done on alterante days and total twelve sessions will be given. Intervention 2: Intervention group: Group B Routine physical Therapy exercise,  patients will get thermotherapy through hot pack for 10 minutes will be applied on Lumbar region before exercises then routine physical therapy which includes patient education ,posture care  and exercises as three sets of 10 repetition of  bridging, prone leg raises, trunk extension in prone with arms behind the back, trunk rotation exercises, knee to chest and prone position with diagonal elevation of the arm and leg exercise. This will be done on alterante days and total twelve sessions will be given.</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 VIRTUAL REALITY EXERCISES ON CLINICAL OUTCOMES IN PATIENTS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CONTROLLED TRIAL  and all collected deidentified IPD will be shared.

When:
After Publication

To whom:
people working in academic institutions  and researchers

Conditions:
on permission from investigator

Where to obtain:
Through email to Investigator 
waqarafzal621@gmail.com

How to obtain:
Through Email and phone
waqarafzal621@gmail.com
00923214668377

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ashfaq Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University Of Lahore 1-Km Defence Road، Near Bhuptian Chowk، Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35963421</telephone>
        <email>ashfaaqpt@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashfaq Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University Of Lahore 1-Km Defence Road، Near Bhuptian Chowk، Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35963421</telephone>
        <email>ashfaaqpt@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Low back pain that persists for more than 12 weeks
Non radiating low back pain
Localized pain in lumbar spine
Both males and females
Age between 25 to 50 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of any trauma or fracture of the spine or lower limb
History of any cardiac ,metabolic, endocrine, Pott’s disease or any other systematic disease
History of any neurological diseases such as Parkinson’s disease, stroke and epilepsy
History of any Previous surgery of spine
Patient on corticosteroid or anticoagulants
History of any Drug abuse
Any Congenital deformity
History of any pain, pathology or musculoskeletal disorder in lower limb
History of any neurological conditions
History of having exposure to virtual reality games or exercises in past three months
Virtual reality games phobia
Pregnant female</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: Group A will get Virtual reality exercises. The Kinect device will be used for Virtual Reality (VR) Exercises in which patient will perform exercises through reflex ridge VR game which includes trunk slide flexion, jumping, sitting to avoid hitting the obstacles and combine movement of legs and arms 5 minutes as displayed on wall mounted LCD, then after 30 seconds rest patient will perform exercises through Body Ball VR game which includes moving arm, pushing head and kicking the ball for 5 minutes. Prior to VR exercise thermotherapy through hot pack for 10 minutes will be applied on Lumbar region. In addition to VR exercise patients will get routine physical therapy which includes patient education ,posture care  and exercises as three sets of 10 repetition of  bridging, prone leg raises, trunk extension in prone with arms behind the back, trunk rotation exercises, knee to chest and prone position with diagonal elevation of the arm and leg exercise. This will be done on alterante days and total twelve sessions will be given.</i_keyword>
      <i_keyword>Intervention group: Group B Routine physical Therapy exercise,  patients will get thermotherapy through hot pack for 10 minutes will be applied on Lumbar region before exercises then routine physical therapy which includes patient education ,posture care  and exercises as three sets of 10 repetition of  bridging, prone leg raises, trunk extension in prone with arms behind the back, trunk rotation exercises, knee to chest and prone position with diagonal elevation of the arm and leg exercise. This will be done on alterante days and total twelve sessions will be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: before intervention and then on 4th, 8th and 12th week. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: before intervention and then on 4th, 8th and 12th week. Method of measurement: Modified Oswestry low back Disability Questionnaire.</prim_outcome>
      <prim_outcome>Lumbar Range of motion. Timepoint: before intervention and then on 4th, 8th and 12th week. Method of measurement: Inclinometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: before intervention and then After 12th session. Method of measurement: SF-36.</sec_outcome>
      <sec_outcome>Muscle Endurance. Timepoint: before intervention then on  4th, 8th and 12th session. Method of measurement: Biering–Sorensen test.</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 Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-22</approval_date>
        <contact_name>Institutional Review Board</contact_name>
        <contact_address>The University of Lahore, 1 - KM Defence Road, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
