<?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>IRCT20210723051960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Corrective Exercises on Balance, Head Alignment, Sense of Position and Neck Endurance of Visually Impaired Students</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of an 8-Week Combined Tele-Exercises on Balance, Forward Head, Proprioception and Neck Muscle Endurance of Students With Visual Impairement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57671</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the Restricted randomization method for all study groups with equal sample size, and among the various restricted randomization methods, we will use Stratified randomization before random allocation, so that both groups in terms of severity of visual impairment and age become homogeneous as far as possible. First, students with more severe visual impairments will be grouped according to the age (or educational level) component. Thus, we consider a number for each person. We throw the balls (sheets) into a container and then randomly remove the balls (sheets) from the container without replacement. We record the generated sequence and place it in two groups of control and experimental. Then we will divide the rest of the participants who have milder visual impairment according to their age (or educational level) in the same way (using balls (sheets) without replacement), and will place them in two groups of control and experimental. Concealment will not be performed as it is not possible to disclose random sequencing and be aware of subsequent allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Balance. Condition 2: Forward head. Condition 3: Neck proprioception. Condition 4: Neck muscle endurance.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will perform UF exercises for 2 months, 3 days a week and each session for 60 to 70 minutes. Each session consists of 3 parts of a 5-part exercise. At the beginning of the exercise program, a general warm-up is performed for 10 minutes and then a specific warm-up of the neck area for 30 seconds. After that, the training sections are performed three times: 1-Static balance exercises are combined with proprioception exercises and are performed for 2 minutes. 2-Cardiovascular endurance exercises are combined with dynamic balance exercises and are held for 30 seconds, then 1 minute of rest is included. 3-Exercises for muscle endurance in the neck area (flexors and extensors) are combined with exercises for correcting the angle of the head and held for 30 seconds. After the end of each part and 1 to 2 minutes of rest, the next parts are done in the same way. After completing the three parts, the parts are repeated from the beginning, and after each part is repeated 3 times, the neck flexibility exercises are performed for 30 seconds and 3 repetitions. At the end of 5 minutes the general cooling is done. Intervention 2: Control group: This group will not receive any training during the time the experimental group is doing the exercises.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor2, Right Side No. 3, Bahar Alley, 23(Khordad) Alley, Ghaemieh St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8177955795</zip>
        <telephone>+98 31 3776 6701</telephone>
        <email>zahra.ebrahimi7379@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mojtaba Babaei khorzoghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical education center, Isfahan University of Technology</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8415683111</zip>
        <telephone>+98 31 3391 2940</telephone>
        <email>babaei@iut.ac.ir</email>
        <affiliation>Isfahan University of Technology, Physical education center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Craniovertebral angle less than 50 degrees
Interest and written consent of parents and students
Educational (use of large-print book) or legal visual impairment (visual acuity between 20/70 and 20/200 in the better eye after vision correction)
7-18 years old students</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute erectile deformity and apparent differences in limb length
Nervous system and auditory system defects
Fractures, surgery or joint diseases of the spine
Dizziness, headache and severe pain in the neck or upper limbs
A history of regular exercise, occupational therapy, or correctional exercises in the past year
Mental diseases
Other disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></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: This group will perform UF exercises for 2 months, 3 days a week and each session for 60 to 70 minutes. Each session consists of 3 parts of a 5-part exercise. At the beginning of the exercise program, a general warm-up is performed for 10 minutes and then a specific warm-up of the neck area for 30 seconds. After that, the training sections are performed three times: 1-Static balance exercises are combined with proprioception exercises and are performed for 2 minutes. 2-Cardiovascular endurance exercises are combined with dynamic balance exercises and are held for 30 seconds, then 1 minute of rest is included. 3-Exercises for muscle endurance in the neck area (flexors and extensors) are combined with exercises for correcting the angle of the head and held for 30 seconds. After the end of each part and 1 to 2 minutes of rest, the next parts are done in the same way. After completing the three parts, the parts are repeated from the beginning, and after each part is repeated 3 times, the neck flexibility exercises are performed for 30 seconds and 3 repetitions. At the end of 5 minutes the general cooling is done.</i_keyword>
      <i_keyword>Control group: This group will not receive any training during the time the experimental group is doing the exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static balance. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Using a single-legged standing test with open eyes.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Using the modified star excursion balance test.</prim_outcome>
      <prim_outcome>Forward head. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Using a photo of the lateral view of people and measuring the cranio-cervical angle by Kinovea software.</prim_outcome>
      <prim_outcome>Repositioning error. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Using laser marker and calibrated screen.</prim_outcome>
      <prim_outcome>Endurance of the deep flexor muscles of the neck. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Using the deep neck flexor endurance test.</prim_outcome>
      <prim_outcome>Endurance of deep neck extensor muscles of the neck. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Using deep neck extensor endurance test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Musculoskeletal discomfort. Timepoint: Before the start of the interventions and a few days after the end of the training interventions. Method of measurement: Cornell Musculoskeletal Discomfort Questionnaire (CMDQ).</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>2021-07-07</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Isfahan Branch (Khorasgan)</contact_name>
        <contact_address>University Blvd, Arghavanieh, East Jay St Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
