<?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>IRCT20200511047403N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-08</date_registration>
      <primary_sponsor>Abdullah Hospital</primary_sponsor>
      <public_title>Effects of Hydrotherapy versus Land Based Exercises on Pain and Grip Strength in Osteoarthritis of Hand</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Hydrotherapy versus Land Based Exercises on Pain and Grip Strength in Osteoarthritis of Hand</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After assessing the eligibility based on inclusion and exclusion criteria, the participants will be requested to take part in study with written as well as informed consent. The participants will be randomly allocated into either a water-based or land based exercise group by using lottery method. The participants will be assigned the group according to even or odd number drawn by the patient from the box. The participants drawing even number will be allocated to land-based exercise group and the participants with even number will be allocated to water-based exercise group, Blinding description: Participant will be allocated to the assigned treatment group after informed consent. participant will not be aware of any other treatment given to other participant of same condition. Outcome assessor and data analyzer will be unaware of the treatment given to the participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hand osteoarthritis, which is the most frequently occurring joint disease, commonly affecting first carpometacarpal joint, interphalangeal joints and distal and proximal interphalangeal joints (DIP and PIP). Functional limitations of hand osteoarthritis are pain, decreased hand strength and flexibility, and inhibition of activity and limitation of participation in functional tasks. Distorted physical appearance, lack of activity, and great loss of mastery may compromised the role of hand as well as self-identity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Water based Exercises (Hydrotherapy). Intervention 2: Intervention group 2: Land Based Exercises.</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 information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Naeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Railway Chowk, Karimpura, Lalamusa, Gujrat, Punjab</address>
        <city>Lalamusa</city>
        <country1>Pakistan</country1>
        <zip>50200</zip>
        <telephone>+92 53 7511911</telephone>
        <email>zainitimi@gmail.com</email>
        <affiliation>Abdullah Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Naeem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Railway Chowk, Karimpura, Lalamusa, Gujrat, Punjab</address>
        <city>Lalamusa</city>
        <country1>Pakistan</country1>
        <zip>50200</zip>
        <telephone>+92 53 7511911</telephone>
        <email>zainitimi@gmail.com</email>
        <affiliation>Abdullah Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects between the age of 40-60 years.
Criteria based on American College of Rheumatology</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with co morbidities
Traumatic injuries of hand
Hand surgery past 6 weeks
Steroid injections past 2 weeks
Cognitive or mental dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Arthrosis, unspecified</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: Water based Exercises (Hydrotherapy)</i_keyword>
      <i_keyword>Intervention group 2: Land Based Exercises</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and, 2 weeks, 6 months. Method of measurement: Numerical Pain Rating Scale.</prim_outcome>
      <prim_outcome>Grip Strength. Timepoint: before intervention and, 2 weeks, 6 months. Method of measurement: Hand Held Dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hand function. Timepoint: Before intervention and, 2 weeks, 6 months. Method of measurement: Functional Index for Hand Osteoarthritis (FIHOA).</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>Abdullah Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Riphah College of Rehabilitation Sciences (RCRS) Research Ethical Committee (REC)</contact_name>
        <contact_address>Near Hajj Complex, I-14, Islamabad, Islamabad Capital Territory Islamabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
