<?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>IRCT20160531028186N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-09</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of hydrotherapy on balance in patients with grade 2 and 3 knee osteoarthritis: A randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hydrotherapy on balance in patients with grade 2 and 3 knee osteoarthritis: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40894</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is based on permutation blocks. The randomization unit is an individual. The random number table is used Participants in the study are selected based on simple and accessible sampling. Each person will be selected based on the criteria for entering the study. The placement of people in groups is based on permutation blocks, Blinding description: Patients with knee osteoarthritis and data collectors   are kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: The control group received routine physical therapy therapy in 12 sessions three times a week for 4 consecutive weeks, including TENS and Hot Pack (for 20 minutes), a warm-up phase (for 5 minutes), stretching exercises (fifteen Seconds for three to four repetitions) for hamstring muscles, quadriceps, iliosus and planar ankle flexors and slipping the heel on the bed in supine position in order to maintain and increase the range of motion, 10 minutes of isometric, concentric and resistance strengthening exercises (ten seconds Ten repetitions) for hamstring muscles, hip adducts, hip abductors, dorsi flexors and plantar flexors, and last 5 minute  cooling phase include: walking and stretching muscles mentioned the warm-up phase. Intervention 2: Hydrotherapy Group: In addition to routine physiotherapy, the hydrotherapy program (for a maximum of 20 minutes) receive( in 12 sessions three times a week for 4 consecutive weeks), including: Balancing exercises in the water. Intervention 3: Land base exercise group in addition to routine physiotherapy treatments, they receive a special balance (for a maximum of 20 minutes)( in 12 sessions three times a week for 4 consecutive weeks) on the land.</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:
All of the data can be shared.

When:
6 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers and specialists in this field 
It must be ensured that data will not be misused

Where to obtain:
pt.f_hajmohammadi@zaums.ac.ir
pt.farzaneh24@gmail.com

How to obtain:
The applicant must clearly and concisely present his / her intention. After about two to four weeks of verification, the data will reach him

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Hosseinifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64855-98136</zip>
        <telephone>+98 54 3342 4675</telephone>
        <email>fardash_s@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammad Hosseinifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64855-98136</zip>
        <telephone>+98 54 3342 4675</telephone>
        <email>fardash_s@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients (women aged 45-65) with osteoarthritis knee grad 2 or 3 knee osteoarthritis, according to Kellgren-Lawrence grade, can be trained to walk on urban obstacles.
No history of diseases such as urinary incontinence, open wound, skin diseases, heart disease lung disease, uncontrolled hypertension, uncontrolled diabetes
Any neurological disorders, such as epilepsy, dizziness and problems vestibular based on testing dynamic visual acuity, Stroke and Parkinson.
The patient is not required to use walking accessories like a cane.
There is no articular injection in the last three months.
There is no traumatic surgery in the lower extremity.
Do not have any damage to the knee that has just occurred.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reporting an increase in symptoms by the patient during treatment sessions
The patient does not complete the treatment sessions
The patient will use other treatments during the study</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>The control group received routine physical therapy therapy in 12 sessions three times a week for 4 consecutive weeks, including TENS and Hot Pack (for 20 minutes), a warm-up phase (for 5 minutes), stretching exercises (fifteen Seconds for three to four repetitions) for hamstring muscles, quadriceps, iliosus and planar ankle flexors and slipping the heel on the bed in supine position in order to maintain and increase the range of motion, 10 minutes of isometric, concentric and resistance strengthening exercises (ten seconds Ten repetitions) for hamstring muscles, hip adducts, hip abductors, dorsi flexors and plantar flexors, and last 5 minute  cooling phase include: walking and stretching muscles mentioned the warm-up phase</i_keyword>
      <i_keyword>Hydrotherapy Group: In addition to routine physiotherapy, the hydrotherapy program (for a maximum of 20 minutes) receive( in 12 sessions three times a week for 4 consecutive weeks), including: Balancing exercises in the water</i_keyword>
      <i_keyword>Land base exercise group in addition to routine physiotherapy treatments, they receive a special balance (for a maximum of 20 minutes)( in 12 sessions three times a week for 4 consecutive weeks) on the land</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before and after the period of the interventions. Method of measurement: Biodex system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before and after the period of the interventions. Method of measurement: Using Visual Analog Scale (VAS) questionnaire.</sec_outcome>
      <sec_outcome>Risk of falling. Timepoint: Before and after the period of the interventions. Method of measurement: Biodex system.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Before and after the period of the interventions. Method of measurement: WOMAC questionnaire.</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>Vice Chancellor for Research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-09</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
