<?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>IRCT20200513047419N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-15</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Comparative study of open and closed kinetic chain exercises on balance and range of motion in patients with knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of open and closed kinetic chain exercises on balance and range of motion in patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48098</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into 2 groups using computer generated random number table, Blinding description: Outcome assessor will be kept blinded about the treatment protocols and study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis (OA) is a most common chronic degenerative joint disease, affecting weight bearing joints. It gradually leads to a disability restricting the individual from various daily functional activities. It is a combination of mechanical abnormalities characterized by degradation of articular cartilage, articulating joints and subchondral space. This damage to articular cartilage leads to fibrillation, fissures, gross ulcerations and finally disappearance of the full thickness of articular cartilage.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group 1:Open chain exercise of knee using cuff weights of (0.5-2.5Kg) tied on ankle or dorsum of foot in a progressive resistance training according to the strength of the patient by finding his/her 1 repetition maximum. Therefore, from that 1 RM by calculating 75% of its 1RM we can find its 10RM. As 75% of 1RM makes 10RM for that specific exercise. This 1 RM AND 10 RM will be found in first session only. Intervention 2: Intervention group 2: Closed chain exercises including step up and step down, terminal extension in standing using therapeutic resistance band of different resistances light, medium and medium to heavy using three colours yellow, red and green respectively in standing position according to their submaximal strength in first session.Two times per week sessions of 1month protocol will be done in weight bearing/standing position (1 set of 10reps).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Daanish Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Lahore, Pakistan-54000</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>0092 42 351261108</telephone>
        <email>6686@vle.riphah.edu.pk</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Daanish Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>28-M quaied e azam industrial state lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>0092 42 351261108</telephone>
        <email>6686@vle.riphah.edu.pk</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1: Patients between 45-65 years of age and suffering from knee pain for more than 3 months.
Osteoarthritis confirmed by radiographic imaging, Grade I and II according to Kllegren and Lawrence classification of knee Osteoarthritis.
Unilateral knee osteoarthritis.
Both males and females are included in the study</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Patients suffering from degenerative diseases of other lower extremity joints.
•	Recent fractures.
•	Vertigo
•	Chronic heart disease.
•	Patients having other musculoskeletal problems with Red flag signs For instance: Osteoporosis, Paget’s disease, Rheumatoid arthritis.
•	Prolonged immobilization.
•	Patients having neurological deficits/Hemiplegics.
•	Osteoarthritis of Bilateral knee joint.
•	Patients who are not able to ambulate without assistive device or aid.
•	Patients who have received knee surgery in past 3 months.
•	Patients who have received intra-articular injection in last 6 weeks prior to study are excluded from research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</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:Open chain exercise of knee using cuff weights of (0.5-2.5Kg) tied on ankle or dorsum of foot in a progressive resistance training according to the strength of the patient by finding his/her 1 repetition maximum. Therefore, from that 1 RM by calculating 75% of its 1RM we can find its 10RM. As 75% of 1RM makes 10RM for that specific exercise. This 1 RM AND 10 RM will be found in first session only</i_keyword>
      <i_keyword>Intervention group 2: Closed chain exercises including step up and step down, terminal extension in standing using therapeutic resistance band of different resistances light, medium and medium to heavy using three colours yellow, red and green respectively in standing position according to their submaximal strength in first session.Two times per week sessions of 1month protocol will be done in weight bearing/standing position (1 set of 10reps).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before treatment, after 2 weeks, after 4 weeks at the end of treatment. Method of measurement: Dynamic y balance test.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before treatment, after 2 weeks, after 4 weeks at the end of treatment. Method of measurement: Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain intensity. Timepoint: Before treatment, after 2 weeks, after 4 weeks at the end of treatment. Method of measurement: Visual analogue scale.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-09</approval_date>
        <contact_name>Research Ethical Committee (REC)  Riphah College of Rehabilitation &amp; Allied Health Sciences</contact_name>
        <contact_address>Riphah International University - Lahore Campus - 28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Lahore, Pakistan-54000 lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
