<?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>IRCT20170712035052N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Backward Gait on Biomechanical Walking Parameters in Patients with Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of retrowalking training protocol on Gait Kinematics and kinetics parameters of patients with medial knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37909</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>medial knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The subjects were 21 healthy men and 42 male patients with knee osteoarthritis who were divided into experimental and control groups according to the Kellgren and Lawrence radiologic scale and the visual analogue scale.The effects of retro-gait training protocol on Kinematics and kinetics parameters knee osteoarthritis gait hasn’t been considered in the literature. Effects of retro walking: reducing shear force, increasing extensor moment and to gain flexibility around knee, decrease in eccentric quadriceps activity , patellofemoral joint stresses  that are often associated with anterior knee pain. Therefore, these advantages make retro-gait a safe and effective component of rehabilitation programs.  The experimental group performed backward gait training for six weeks, 3 sessions per weeks. Subjects accomplish a five minute warm-up on followed by backward gait exercises. Backward gait training protocol including Interval training (3 set, 2-4-6 reps), continuous training (2sets,2 and 3 minutes), Stretching exercises(3 minute), Strength training , Exercise intensity increased in the second week. Patients were stopped immediately once they report pain or discomfort during retro gait. Each exercise session began with warm up exercises , followed by backward gait exercises and ended up by cool-down exercises. Intervention 2: Control group: The 42 patients with knee OA were divided into experimental and control groups according to the Kellgren and Lawrence radiologic scale and the visual analogue scale. Participants in the control group did not receive any training. Intervention 3: Control group: Furthermore, among the staff of the university 21 healthy male peers were selected as normal controls. The participants in the normal control group did not receive any training during the study period.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Jalalvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan Province, Hamedan, Professor Mussivand Blvd</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6518115743</zip>
        <telephone>+98 81 3448 1000</telephone>
        <email>jalalvand_ali@iauh.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Jalalvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan Province, Hamedan, Professor Mussivand Blvd</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6518115743</zip>
        <telephone>+98 81 3448 1000</telephone>
        <email>jalalvand_ali@iauh.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients were able to perform activities of daily living including walking, running, up and down stairs
The patients were knee osteoarthritis according to the Kelgerand and Lawrence index with grade 2 and 3 osteoarthritis</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>No patient had problems in standing and walking
Radiological symptoms of osteoarthritis in the knee, pain and tenderness on the medial side of the knee.
All patients with knee OA were not in the acute phase of the disease
The lack of consumption (non-steroid anti-inflammatory) from a week before entering the study.
Not having history of trauma, injury or surgery, and lower limb fracture
Not having history of joint threatening diseases (Osteonecrosis, diabetes, osteoporosis, rheumatoid arthritis, musculoskeletal neurological disease)
The lack of a long history of drug use and non-drug addiction</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The subjects were 21 healthy men and 42 male patients with knee osteoarthritis who were divided into experimental and control groups according to the Kellgren and Lawrence radiologic scale and the visual analogue scale.The effects of retro-gait training protocol on Kinematics and kinetics parameters knee osteoarthritis gait hasn’t been considered in the literature. Effects of retro walking: reducing shear force, increasing extensor moment and to gain flexibility around knee, decrease in eccentric quadriceps activity , patellofemoral joint stresses  that are often associated with anterior knee pain. Therefore, these advantages make retro-gait a safe and effective component of rehabilitation programs.  The experimental group performed backward gait training for six weeks, 3 sessions per weeks. Subjects accomplish a five minute warm-up on followed by backward gait exercises. Backward gait training protocol including Interval training (3 set, 2-4-6 reps), continuous training (2sets,2 and 3 minutes), Stretching exercises(3 minute), Strength training , Exercise intensity increased in the second week. Patients were stopped immediately once they report pain or discomfort during retro gait. Each exercise session began with warm up exercises , followed by backward gait exercises and ended up by cool-down exercises.</i_keyword>
      <i_keyword>Control group: The 42 patients with knee OA were divided into experimental and control groups according to the Kellgren and Lawrence radiologic scale and the visual analogue scale. Participants in the control group did not receive any training.</i_keyword>
      <i_keyword>Control group: Furthermore, among the staff of the university 21 healthy male peers were selected as normal controls. The participants in the normal control group did not receive any training during the study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kinematics parameters (the Spatial, Temporal, Distance variables and ROMs). Timepoint: This study was performed with a pretest-posttest design in two groups (healthy and patient) and an experimental group (subjects with medial knee osteoarthritis). Method of measurement: A Vicon motion analysis system with T-Series cameras were used to measure the Kinematics parameters. The Kinematics parameters of gait including were calculated by Vicon Nexus 1.8.5 software in pretest-posttest trials. All data were then extracted by Polygon 3.5.1.</prim_outcome>
      <prim_outcome>Kinetics parameters (vertical ground reaction forces, Peak adduction moment and adduction moment impulse). Timepoint: This study was performed with a pretest-posttest design in two groups (healthy and patient) and an experimental group (subjects with medial knee osteoarthritis). Method of measurement: A Vicon motion analysis system with four T-Series cameras and two Kistler force plates  were used to measure parameters by Vicon Nexus 1.8.5 , Polygon 4.1.2 software .</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-23</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Sciences, Shahid Fahmideh Ave. Hamadan, Islamic Republic of Iran Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
