<?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>IRCT20200827048538N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-02</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effects of Routine physical therapy with and without Hydrotherapy in knee Osteoarthritis.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Routine physical therapy with and without Hydrotherapy on Pain Intensity and Functional activity in knee Osteoarthritis Patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50599</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Nill, Randomization description: Randomization was done by using lottery method. Non- Probability Convenient Sampling was used to recruit the individuals for the study and then randomization was done by lottery method to divide the individuals into 2 groups. Sealed envelope will be used for allocation concealment, Blinding description: The assessor was blind and unaware of the treatment given into both control and study groups. Assessor was take 1st week and 4th week of followup total scoring.</study_design>
      <phase>3</phase>
      <hc_freetext>Grade 2 and Grade 3 Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Control Group: In regular physical therapy treatment include TENS, hot pack and isometrics of knee joint. Treatment period for almost 40 minutes. Total 12 sessions were given to patients, 3 times per week for consecutive 4 weeks. Intervention 2: Intervention group: In which both routine physical therapy and hydrotherapy treatment include . In hydrotherapy each session were include the following components: warm-up, lower limb ROM exercises and strengthening exercises. The program was including into three stages: warm-up (5 min), strengthening exercises (30 min), and a cool-down session (5 min). Warm-up exercises consisted of walking in the water and increasing velocity followed by stretching exercises of the anterior and posterior muscles of the lower limbs. After the warm-up session, participants will be performed lower limb strengthening exercises. In strengthening exercises Single leg squad, Semi squad, Side walk include. The cool-down session consisted of light walking. Participants will be instructed to perform the exercises on the high possible intensity. Ankle weight will be used around the ankle to provide additional resistance. Treatment period for almost one hour.  Total 12 sessions were given to patients, 3 times per week for consecutive 4 weeks.</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 there is no further decision and information decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sofia tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no.23; D/1 street; no.41 new colony Mujahidabad; Sahuwari</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 36849457</telephone>
        <email>sofiatariq32@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sofia Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no.23 D/1 street no.41 new colony mujahidabad sahuwari lahore pakistan.</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 36849457</telephone>
        <email>sofiatariq32@gmail.com</email>
        <affiliation>University of lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both males and females
40 to 65 years of the age
Patients with osteoarthritis (OA) clinically diagnosed by orthopedic surgeon
Grade 2 and Grade 3 osteoarthritis
Have been diagnosed with at least unilateral degenerated OA</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hydrophobia
Traumatic OA
Recent surgery
Any cardiac disease
Neurological disorders
Fracture of lower limb
Knee joint replacement
Skin diseases of lower limb
Structural and functional disability
Pathological and systematic disease
Not to be used any walking support (such as walking stick or crutches)</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>Control Group: In regular physical therapy treatment include TENS, hot pack and isometrics of knee joint. Treatment period for almost 40 minutes. Total 12 sessions were given to patients, 3 times per week for consecutive 4 weeks.</i_keyword>
      <i_keyword>Intervention group: In which both routine physical therapy and hydrotherapy treatment include . In hydrotherapy each session were include the following components: warm-up, lower limb ROM exercises and strengthening exercises. The program was including into three stages: warm-up (5 min), strengthening exercises (30 min), and a cool-down session (5 min). Warm-up exercises consisted of walking in the water and increasing velocity followed by stretching exercises of the anterior and posterior muscles of the lower limbs. After the warm-up session, participants will be performed lower limb strengthening exercises. In strengthening exercises Single leg squad, Semi squad, Side walk include. The cool-down session consisted of light walking. Participants will be instructed to perform the exercises on the high possible intensity. Ankle weight will be used around the ankle to provide additional resistance. Treatment period for almost one hour.  Total 12 sessions were given to patients, 3 times per week for consecutive 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional activity. Timepoint: Pre-assessment was taken at 1st week and final assessment was taken after 4 weeks. Method of measurement: Functional activity was measured by WOMAC Scale.</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: Pre-assessment was taken at 1st week and final assessment was taken after 4 weeks. Method of measurement: Pain assessment was measured by VAS Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Nill</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-26</approval_date>
        <contact_name>University Institute of Physical Therapy</contact_name>
        <contact_address>House no.23; D/1 street; no.41 new colony Mujahidabad; Sahuwari Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
