<?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>IRCT20190715044216N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-09</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint</public_title>
      <acronym>COEOAPOIQSIOOKJ</acronym>
      <scientific_title>Comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60916</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group according to consort guideline 2010. Written informed consent will be taken.  After enrollment into study, patient will be allocated either to Group 1 , Group 2 and Group 3 by lottery method. No. of Chits will be equal to total sample size. Each patients will be requested to draw a chit from the box and after that patient will be recruited into either Group 1 or Group 2 and 3.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:will perform quadriceps exercise with ankle in planter flexion position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing. Intervention 2: Intervention group 2: will perform quadriceps exercise with ankle in dorsiflexion position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing. Intervention 3: Intervention group 3: will perform quadriceps exercise with ankle in neutral ankle position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing.</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:
comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint

When:
30-6-2022

To whom:
people working in academic situation

Conditions:
Author will review the request

Where to obtain:
amnabashir41@gmail.com

How to obtain:
request will be entertained through email after which people working in academic institutions will be granted request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amna Bashir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House#924 street# 12 Umar Farooq Block Mohalla Islam Colony Pakpattan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>57400</zip>
        <telephone>+92 305 9710474</telephone>
        <email>amnabashir41@gmail.com</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amna Bashir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House#924 street# 12 Umar Farooq Block Mohalla Islam Colony Pakpattan</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>57400</zip>
        <telephone>+92 307 8325405</telephone>
        <email>amnabahir41@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>X-ray findings of primary osteoarthritis patients with grade ≥ 2  according to Kellgren Lawrence scale
Male and female both were included
Age from 40-60 years old patients were included
Unilateral and bilateral involvement, in case of bilateral involvement more symptomatic knee was included; pain in and around the knee</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>less ankle ROM
History with any injury either soft tissue or bony
Pain radiating into leg in patients with low back pain
Any neurological signs
History with NSAID past three months
Any inflammatory disease such as Gout
History with RA, ankylosing spondylitis
History with metal implants, noncooperative patient, patient with mental disorders
Patients with BMI ≥40 kg/m2 (morbid obesity)</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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:will perform quadriceps exercise with ankle in planter flexion position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing.</i_keyword>
      <i_keyword>Intervention group 2: will perform quadriceps exercise with ankle in dorsiflexion position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing.</i_keyword>
      <i_keyword>Intervention group 3: will perform quadriceps exercise with ankle in neutral ankle position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain, strength. Timepoint: 4 weeks after intervention. Method of measurement: NPRS scale,MMT and WOMAC scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain, strength and functional activity level will be measure  in planterflexion group. Timepoint: Pre-readings than post-readings after 4 weeks . 4 treatment sessions in a week will be given to the subjects. Method of measurement: WOMAC scale, NPRS, MMT.</sec_outcome>
      <sec_outcome>Pain, strength and functional activity level will be measure in Dorsiflexion group. Timepoint: Pre-readings than post-readings after 4 weeks . 4 treatment sessions in a week will be given to the subjects. Method of measurement: WOMAC, NPRS, MMT.</sec_outcome>
      <sec_outcome>Pain, strength and functional activity level will be measure  in neutral ankle position group. Timepoint: Pre-readings than post-readings after 4 weeks . 4 treatment sessions in a week will be given to the subjects. Method of measurement: WOMAC, NPRS , MMT.</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>student</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-07</approval_date>
        <contact_name>Riphah international research and ethics committe</contact_name>
        <contact_address>28M Quid e azam industrial estate kot lakhpat lahore Lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
