<?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>IRCT20090301001722N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Hydrotherapy on proprioception after Anterior Cruciate Ligament Reconstruction</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Aquatic Exercises on Knee proprioception and Altered Motor Control of the Knee Muscles after Anterior Cruciate Ligament Reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41731</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly divided into two groups by a closed envelope method.  The allocation of the subjects will be concealed by using sequentially numbered, sealed and opaque envelopes. On the first day of treatment, the envelope allocated  will be opened by the participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anterior cruciate ligament.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: hydrotherapy. All subjects will undergo 2 sessions of proprioception aquatic exercises for 6 weeks. Each hydrotherapy session will be last 30-45 minutes consisting of three parts: warm-up, main practice, and cooling down. The pool water temperature will be ranged from 28° to 30° C. During the exercises, the individual will be asked to remain at a depth where the water is between the waist and the sternum. The hydrotherapy intervention will be conducted in a professional swimming pool equipped with all needed equipment for aquatic exercises. The main exercises will be done according to individual ability and the patient's response to training. The progression of the training protocol as following: 1-	Single leg stance with eyes open. 2- Single leg stance with eyes closed.3- Single leg stance with leg swing and eyes open. 4-	Single leg stance with leg swing and eyes closed. 5- Single leg squat with eyes open. 6- Single leg squat with eyes closed.7- Rollover walking back and forth on Foam Roll. 8- Rollover walking forward with crossed arms. Intervention 2: Intervention group 2: land therapy. The proprioception exercises applied to land group will be identical in terms of type, intensity and duration to those exercises applied to hydrotherapy group. The leg that will undergo training is the injured leg and must be wearing a sneaker during the exercises, with the knee semi-flexed at approximately 30°. In addition, the individual will not be allowed to support by the contralateral limb or hands. If the subjects lost their balance, they will be asked to lean on the contralateral limb. All patients in both groups are going to begin the same conventional rehabilitation protocol according to evidence-based rehabilitation accelerated protocol by Van Grinsven 2010.</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>Mohammad Reza Hadian Rasanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 8891 3469</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Reza Hadian Rasanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 8891 3469</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 18 and 35 years
Undergone a unilateral ACL reconstruction
No history or signs of injury in the contralateral knee
9 weeks after ACLR
ROM is greater than 100° flexion and complete extension (zero degrees)
Reconstruction using STG autograft
No previous history of lower limb surgery before the lesion and absence of neurological disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to understand and/or perform the required maneuvers
fear of water
uncontrolled epilepsy
chlorine sensitivity
infected open
faecal incontinence
myocardial infarction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of anterior cruciate ligament of knee</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: hydrotherapy. All subjects will undergo 2 sessions of proprioception aquatic exercises for 6 weeks. Each hydrotherapy session will be last 30-45 minutes consisting of three parts: warm-up, main practice, and cooling down. The pool water temperature will be ranged from 28° to 30° C. During the exercises, the individual will be asked to remain at a depth where the water is between the waist and the sternum. The hydrotherapy intervention will be conducted in a professional swimming pool equipped with all needed equipment for aquatic exercises. The main exercises will be done according to individual ability and the patient's response to training. The progression of the training protocol as following: 1-	Single leg stance with eyes open. 2- Single leg stance with eyes closed.3- Single leg stance with leg swing and eyes open. 4-	Single leg stance with leg swing and eyes closed. 5- Single leg squat with eyes open. 6- Single leg squat with eyes closed.7- Rollover walking back and forth on Foam Roll. 8- Rollover walking forward with crossed arms.</i_keyword>
      <i_keyword>Intervention group 2: land therapy. The proprioception exercises applied to land group will be identical in terms of type, intensity and duration to those exercises applied to hydrotherapy group. The leg that will undergo training is the injured leg and must be wearing a sneaker during the exercises, with the knee semi-flexed at approximately 30°. In addition, the individual will not be allowed to support by the contralateral limb or hands. If the subjects lost their balance, they will be asked to lean on the contralateral limb. All patients in both groups are going to begin the same conventional rehabilitation protocol according to evidence-based rehabilitation accelerated protocol by Van Grinsven 2010.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knee joint position sense. Timepoint: pre and post-test. Method of measurement: Biodex Isokinetic System.</prim_outcome>
      <prim_outcome>Voluntary response index analysis. Timepoint: pre and post-test. Method of measurement: Surface EMG by Biometrics (Ltd) data Log.</prim_outcome>
      <prim_outcome>Knee function. Timepoint: pre and post-test. Method of measurement: international knee documentation committee questionnaire (IKDC).</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>Vice chancellor for research of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-29</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>6th floor, Tehran University of Medical Science building, Ghods Ave., Keshavarz blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
