<?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>IRCT20200807048331N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-31</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of using elastic band and flamingo exercise on knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two methods using elastic band and flamingo exercise on functional balance, proprioceptive and osteoarthritis indicators in patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization of individuals in the form of restricted randomization will be of the type of random allocation rule. In this way, cards are prepared according to the number of participants and the names of the intervention methods are written on them and placed in a box. Individuals are asked to randomly remove a card from the box (selected cards will not be returned to the box after selection). In this way, the type of intervention will be determined for each person and random allocation will be performed, Blinding description: This study will be of the single blind type. In this way, participants will be unaware of the intervention groups and the type of interventions in other groups and will only perform the intervention intended for them by entering one of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1: Elastic band exercise group that continues these exercises for 8 weeks. The training program for the elastic band will be based on the guidelines provided by the American School of Sports Medicine. This program will include 5-10 minutes of warm-up before training, 5-10 minutes of cooling down after training and 5 sets with 10 repetitions, three days a week for up to 8 weeks and at certain hours (evening). In the first four weeks, a low-strength elastic band (yellow) is used. To increase the resistance of the exercises in the following weeks, by adding one more repetition to the previous movements, up to 15 repetitions and replacement with a new band (red color) will continue. Exercises in this group will include knee flexion / extension, ankle dorsiflexion / plantarflexion, hip adduction / abduction, hip flexion / extension, and internal /external rotation hip. Intervention 2: Intervention group: The second intervention group is the flamingo exercise group. The training program of this group includes standing on one leg, three times a day, each time for one minute and eight weeks and at certain hours (evening). While doing this exercise, the eyes are open and the hand raised to the upper leg may be leaning somewhere and the other hand may be freely in line with the body. Intervention 3: Control group: Group 3: They do not receive any of the above exercises and lead a normal life.</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:
Information on the main outcome will be available

When:
Access starts 6 months after the results are published

To whom:
Researchers

Conditions:
.

Where to obtain:
alisheikhalishahi95@gmail.com
ali.sheikhalishahi@bums.ac.ir

How to obtain:
.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Sheikhalishahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>19 Edalat Alley, Edalat street, Azadshahr</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917143171</zip>
        <telephone>+98 35 3722 0539</telephone>
        <email>alisheikhalishahi95@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Foadoddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Birjand University of Medical Sciences, Ghafari St.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 915 161 5471</telephone>
        <email>foadmohsen@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>45 years and older
Diagnosis and confirmation of knee osteoarthritis by a specialist in rheumatology
Kellgren/Lawrence scale knee osteoarthritis grade 2 and 3
Ability to understand and accept written and informed consent
Ability to walk with or without aids
Do not use a wheelchair to move
No history of surgery and arthroplasty of the knee joint
No Parkinson's disease, epilepsy, dizziness and a history of knee fractures
No underlying diseases such as diabetes, hypothyroidism and neuropathy
Absence of dementia and Alzheimer's
BMI less than 30</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to perform movements due to severe pain or orthopedic limitations
Participate in regular exercise or other specific activity</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1: Elastic band exercise group that continues these exercises for 8 weeks. The training program for the elastic band will be based on the guidelines provided by the American School of Sports Medicine. This program will include 5-10 minutes of warm-up before training, 5-10 minutes of cooling down after training and 5 sets with 10 repetitions, three days a week for up to 8 weeks and at certain hours (evening). In the first four weeks, a low-strength elastic band (yellow) is used. To increase the resistance of the exercises in the following weeks, by adding one more repetition to the previous movements, up to 15 repetitions and replacement with a new band (red color) will continue. Exercises in this group will include knee flexion / extension, ankle dorsiflexion / plantarflexion, hip adduction / abduction, hip flexion / extension, and internal /external rotation hip.</i_keyword>
      <i_keyword>Intervention group: The second intervention group is the flamingo exercise group. The training program of this group includes standing on one leg, three times a day, each time for one minute and eight weeks and at certain hours (evening). While doing this exercise, the eyes are open and the hand raised to the upper leg may be leaning somewhere and the other hand may be freely in line with the body.</i_keyword>
      <i_keyword>Control group: Group 3: They do not receive any of the above exercises and lead a normal life.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional balance. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Berg balance scale, Timed up and go test.</prim_outcome>
      <prim_outcome>Proprioceptive. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Active movement extent discrimination apparatus.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Western Ontario and McMaster universities osteoarthritis index, Visual analogue scale.</prim_outcome>
      <prim_outcome>Joint stiffness. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Western Ontario and McMaster universities osteoarthritis index.</prim_outcome>
      <prim_outcome>Physical performance. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Western Ontario and McMaster universities osteoarthritis index.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-13</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Deputy of research and technology, Birjand University of Medical Sciences, Ghafari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
