<?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>IRCT201601171637N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-03</date_registration>
      <primary_sponsor>Vice chancellor for research-Tarbiat Modares University</primary_sponsor>
      <public_title>The study of the whole body  vibration therapy effects  on  the patients with knee osteoarthritis.</public_title>
      <acronym></acronym>
      <scientific_title>The  study of the  Whole Body Vibration Therapy effects on Pain , Knee Range of Motion, Functional Activities, Electromyography Muscles Activity of the  Lower Limbs and Postural Stability of Patients with Knee Osteoarthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The patients were randomly allocated to three groups: WBVT, placebo and control .&#13;
It is worth noting that patients are not aware of the  different treatment groups and were treated at different times.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: The whole body vibration training  group will do their intervention on a vibration platform .The WBVT programme will be done on the Fitvibe vertical vibration platform with amplitude of 3 mm and frequency of 30 Hz. The patients will ask to stand barefoot on the platform with a 30 degree knee flexion during training. The vibration training will consist of two set with three repetitions of one-minute WBVT and one-minute rest between repetitions and five minute rest between the sets during the first week to avoid patients' muscles fatigue. Every week a set will be added to the WBVT program, so that the WBVT in the fourth week will be consisted of five sets. The patients will be allowed to sit down on a chair for the rest between the sets. Intervention 2: The patient in placebo group will do their intervention on a vibration platform as WBVT group while the vibration system is off and does not transmit any vibration to the patient's feet while standing in semi squat position. Their protocol will be similar to the WBVT group but without receiving vibration. The reason for designing a placebo group in this study is to evaluate the placebo and psychological effects of WBVT. Intervention 3: The practice at home group will be educated to do two exercises in three set with ten repetitions and a five-second hold for each exercise and a five-second pause. The exercise program of the group will consist of static contractions of quadriceps muscles and SLR which will be done twice a day at home. The exercise therapy course is also four weeks in this group.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ٍEbrahim Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-318, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 4511</telephone>
        <email>ebiabasi@yahoo.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadighe Kahrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy departmentو Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-318, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8288 4511</telephone>
        <email>kahrizis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria: &#13;
Knee OA with Kellgren–Lawrence grade II and III in simple X-ray;&#13;
 between 55-75 years old;&#13;
 no previous or concomitant injury on the knee and other lower extremity joints;  no previous history of serious knee trauma, surgery and arthroplasty;&#13;
 no history of knee intra-articular injection of hyaluronic acid or steroid in the last 6 months;&#13;
 no history of surgery or traumatic injuries to the lower limbs;&#13;
 no history of medical problems such as cardiopulmonary diseases,  neurologic diseases,  malignant diseases,  chronic diseases such as diabetes;&#13;
 no history of newly repaired fracture and bone implants;&#13;
 no pacemaker and no history of WBVT contraindications for participants of the WBVT group;&#13;
&#13;
 The exclusion criteria:&#13;
Any systemic disorder in the body, according to the patient and physician;&#13;
 taking any medication  according to the patient;&#13;
 incomplete treatment and assessment;&#13;
 WBVT intolerance for the WBVT group;</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M 17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other primary gonarthrosis</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 whole body vibration training  group will do their intervention on a vibration platform .The WBVT programme will be done on the Fitvibe vertical vibration platform with amplitude of 3 mm and frequency of 30 Hz. The patients will ask to stand barefoot on the platform with a 30 degree knee flexion during training. The vibration training will consist of two set with three repetitions of one-minute WBVT and one-minute rest between repetitions and five minute rest between the sets during the first week to avoid patients' muscles fatigue. Every week a set will be added to the WBVT program, so that the WBVT in the fourth week will be consisted of five sets. The patients will be allowed to sit down on a chair for the rest between the sets.</i_keyword>
      <i_keyword>The patient in placebo group will do their intervention on a vibration platform as WBVT group while the vibration system is off and does not transmit any vibration to the patient's feet while standing in semi squat position. Their protocol will be similar to the WBVT group but without receiving vibration. The reason for designing a placebo group in this study is to evaluate the placebo and psychological effects of WBVT.</i_keyword>
      <i_keyword>The practice at home group will be educated to do two exercises in three set with ten repetitions and a five-second hold for each exercise and a five-second pause. The exercise program of the group will consist of static contractions of quadriceps muscles and SLR which will be done twice a day at home. The exercise therapy course is also four weeks in this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre and post  intervention. Method of measurement: Visual Analogue Scale for pain( 100 mm Ruler).</prim_outcome>
      <prim_outcome>Knee Range of Motion. Timepoint: Pre and post  intervention. Method of measurement: Goniometery in degree.</prim_outcome>
      <prim_outcome>Time up &amp; Go test. Timepoint: Pre and post  intervention. Method of measurement: Chronometer ( sec).</prim_outcome>
      <prim_outcome>6 minute walk test. Timepoint: Pre and post  intervention. Method of measurement: Meter.</prim_outcome>
      <prim_outcome>Electromyographic (EMG) root mean square (RMS) response of some lower limb muscles during maximum voluntary isometric contraction. Timepoint: Pre and post  intervention. Method of measurement: Electromygraphy.</prim_outcome>
      <prim_outcome>Overall Sway Index. Timepoint: Pre and post  intervention. Method of measurement: Biodex Balance System.</prim_outcome>
      <prim_outcome>Antroposterior Sway Index. Timepoint: Pre and post  intervention. Method of measurement: Biodex Balance System.</prim_outcome>
      <prim_outcome>Medilateral Sway Index. Timepoint: Pre and post  intervention. Method of measurement: Biodex Balance System.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anteroposterior Sway. Timepoint: pre andp post intervention. Method of measurement: Forceplate.</sec_outcome>
      <sec_outcome>Sway Average Velocity. Timepoint: pre andp post intervention. Method of measurement: Forceplate.</sec_outcome>
      <sec_outcome>Mediolateral Sway. Timepoint: pre andp post intervention. Method of measurement: Forceplate.</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-Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-23</approval_date>
        <contact_name>Ethical  Committee of Medicine School-Tarbiat Modares University</contact_name>
        <contact_address>Physiotherapy Department,Medicine school,Jalal Al Ahmad Highway. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
