<?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>IRCT20200112046099N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-04</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The immediate effect of kinesio taping of quadriceps muscle on position sense of knee joint following full squat in patients with multiple sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The immediate effect of kinesio taping of quadriceps muscle on position sense of knee joint following full squat in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45059</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Relapsing-remitting multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention group: MS group with relapsing remitting MS, Control group: Healthy people. Both groups will receive a similar intervention in a treatment session that includes measuring the position sense of knee joint in four stages: a) before fatigue, b) after fatigue, when we ask the participant to stand near the edge of the bed and do a rhythmic squat with a steady metronome, and when he feels he has reached level 13 of the BORG (somewhat hard) questionnaire, the protocol will stop.c) 30-40% traction of kinesiotape on the three heads of the quadriceps muscle is attached. And d) Taping and fatigue is combined with the use of a limitator. At each step, we take a picture with a 16-megapixel Canon digital camera that it's validity and reliability have been established..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saina Aliabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation school, In the corner of Safi Ali Shah street, Piche Shemiran, Enghelab street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>s_aliabadi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghola Reza Olyaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation school, At the corner of Safi Ali Shah Street, Piche Shemiran, Enghelab Street, Tehran</address>
        <city>TEHRAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>olyaeigh@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>Recurrent-relapsing MS patients
Disability level by Expanded Disability Status Scale ≤ 6 (EDSS)
Age between 20-35 years
Able to write and read
Muscle strength should be three or more in quadriceps and hamstrings muscles
No history of anemia
No depression according to Patient Health Questionnaire-9 (PHQ-9).
No history of Diabetes
No history of hypothyroidism
No illnesses that increase fatigue, such as myasthenia gravis
Not having disruptive spasticity in doing exercises
No history of surgery or fracture
No history of drug use in the past 6 months
No history of cardiopulmonary diseases
Complaints of fatigue that cause Disturbance in daily activities (should distinguish between extreme daytime sleepiness and fatigue).</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inadequate data recording
Decreasing one's motivation (not wanting to continue cooperation and intentionally declare score 13 in the fatigue questionnaire)
Patient Unables to learn the process</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: MS group with relapsing remitting MS, Control group: Healthy people. Both groups will receive a similar intervention in a treatment session that includes measuring the position sense of knee joint in four stages: a) before fatigue, b) after fatigue, when we ask the participant to stand near the edge of the bed and do a rhythmic squat with a steady metronome, and when he feels he has reached level 13 of the BORG (somewhat hard) questionnaire, the protocol will stop.c) 30-40% traction of kinesiotape on the three heads of the quadriceps muscle is attached. And d) Taping and fatigue is combined with the use of a limitator. At each step, we take a picture with a 16-megapixel Canon digital camera that it's validity and reliability have been established.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. Fatigue following rhythmic full squats, which is an independent variable , and based on the patient's self-expression is assessed using the BORG questionnaire, which has a range of 0-20, and when a person reaches a somewhat hard level, which is equivalent to 13 the full squat operation will not continue. 2. Kinesiotape, which is an independent nominal variable. 3. Multiple sclerosis, which is an independent nominal variable, relapsing remitting type of MS, which has been referred to us by a neurologist. Timepoint: At first, the participant's knee joint was measured with the help of a goniometer, and then he was asked to perform a full rhythmic squat until the moment, according to the BORG questionnaire at level 13, which is actually somewhat hard. The participant's knee position was then re-measured to assess changes in position sense error following rhythmic full squats. In the next step, the kinesiotape was first applied to three of the four heads of quadriceps muscle, and then the patient's knee condition was measured again to asses position sense errors following therapeutic intervention (taping). In the final stage, the person performed a rhythmic full squat protocol on the muscle and the kinesiotape applied on muscle to check for changes in position sense errors following fatigue associated with taping. Method of measurement: Kinesiological tape to examine its therapeutic effect in compense participant's fatigue  and its effect on position sense and using a standard goniometer to assess the patient's position sense (reconstruction from 90 degrees to 45 degrees of knee flexion).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Position sense (including absolute, variable, and constant errors in angle reconstruction) that is a continuous dependent variable and is measured by the variance of the reconstructed angle. it measures with software and Goniameter and camera. Timepoint: Before and after performing the full squat protocol, after attaching the kinesiotape on the quadriceps muscle, and finally after performing the full squat protocol while the tape is attached to the muscle. Method of measurement: To test the position sense, a 16-megapixel Canon camera with a camera lens distance from the patient (80 cm) and a camera height from the ground (70 cm) was first placed. using markers on land marks was then performed on standard areas (greater trochanter of femur, lateral condyle offemur, head of the fibula, and lateral malleolus of the dominant limb). The patient then sat on the edge of the bed with his eyes closed so that his knees were at 90 degrees of flexion and the opposite leg was fixed on an adjustable, motionless stand. With a standard goniometer, the fixed arm of goniameter was placed on the thigh and the movable arm of goniameter was placed on the leg (fibula), the desired angle (about 45 degrees) was determined for the patient, so that the person should test this angle without a manual contact. It was kept for 5 seconds and then the patient was asked to return to the starting position (90 degree angle). The patient was then asked to raise his legs from 90 to 45 degrees with his eyes closed, and whenever he felt that his knee had been raised from 90 to 45 degrees, he would use a laser to flash on the front wall. The moment the laser light was seen, the reconstructed image was immediately photographed. The reconstruction was performed four times with a 5-second break between each repetition. Images were analyzed by the software in Excel environment and changes in the absolute, variable and constant errors of position sense were calculated.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-07</approval_date>
        <contact_name>National Committee on Ethics in Biomedical Research Tehran university of Medical Sciences</contact_name>
        <contact_address>Floor 13, Block A, Headquarters of the Ministry Health and Medical Education,  Simaye Iran street, Between south Falamak and Zarafshan, Qods town, Tehran TEHRAN Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
