<?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>IRCT20200613047759N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of hip joint mobilization with movement on muscle activity, and balance in patients with chronic stroke</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hip joint mobilization with movement on muscle activity pattern, postural control and static and dynamic balance in patients with chronic stroke: Randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48919</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization with a block size of 4 will be done with statistical software, Blinding description: Patients are unaware of whether they are in the control or experimental group. Also all outcome will be measured and analyzed by an experienced physical therapist and statistician, who was blinded to the grouping. Also, in order to blind the participants, the treatment of each group will be done on different days of the week.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: hip joint mobilization with movement technique for three times per week for 4 weeks, a grade III glide will be sustained for 10 seconds and relaxed for 5 seconds over 3 sets of 6 repetitions with a 1- minute rest between sets after receiving 30 minutes of conventional physiotherapy. Intervention 2: Control group:  30 minutes of conventional physical therapy, 3 times a week for 4 weeks as follows: the first 10 minutes of the active and passive range of motion exercises for the lower limb of the affected side; the next 10 min for Weigh Bearing training during sitting and standing; and the final 10 min for walking.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After coordination with the Research Ethics Committee for approval of the ethics committee, participants data file will be provided In complete secrecy and for research purposes only.

When:
After acceptance of the article by the journal

To whom:
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.

Conditions:
Preferably it is only used for the subject of my research, but if research is to be done in order to use the statistical population, the main project executor and the student's main collaborator will make a decision with the permission of the ethics committee.

Where to obtain:
Executors of the project can first be referred to through Dr. Fahimeh Kamali Sarvestani (09177110341), secondly through Dr. Mohsen Razaghi (09173130718) and the main colleague and student collaborator Ms Soudeh Arabzadeh (09369332615).

How to obtain:
6 months after the article was published, referring the request to the executor of the project, in addition, an official letter from the ethics committee will be commented on in order to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soudeh Arabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.18, Niloufar Alley, Hasht Behesht Sharghi St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8157686811</zip>
        <telephone>009831665568</telephone>
        <email>s_arabzadeh@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soudeh Arabzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.18, Niloufar Alley, Hasht Behesht Sharghi St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8157686811</zip>
        <telephone>009831665568</telephone>
        <email>s_arabzadeh@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-The presence of hemiplegia secondary to stroke                                                  -History of stroke onset &gt;6 months and a maximum of 1 year prior to the study                                                                                      -The ability to stand and walk independently without the use of assist-devices                                                                                          -Mini-Mental State Examination score of &gt;24                                                                                          -Within stages 2–4 of Brünnstrom                                                       -The age range of 35-65 years old                                                 -The ability to follow verbal commands</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>-Any orthopedic disease affecting balance control                                                                              -Any neurological condition affecting balance control                                                                                    -Taking any medication that causes peripheral neuropathy             -Have a visual impairment                                                             -Have a hearing impairment                                                             -Have a history of spinal disorders affecting gait and lower limb function                                                                                            -There is a cerebellar stroke at the same time                 -Contraindications for hip joint mobilization             -Contraindications on the use of superficial electromyography</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_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>Experimental group: hip joint mobilization with movement technique for three times per week for 4 weeks, a grade III glide will be sustained for 10 seconds and relaxed for 5 seconds over 3 sets of 6 repetitions with a 1- minute rest between sets after receiving 30 minutes of conventional physiotherapy</i_keyword>
      <i_keyword>Control group:  30 minutes of conventional physical therapy, 3 times a week for 4 weeks as follows: the first 10 minutes of the active and passive range of motion exercises for the lower limb of the affected side; the next 10 min for Weigh Bearing training during sitting and standing; and the final 10 min for walking.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural stability. Timepoint: 1 day before intervention, 1 day after intervention and 14 days after intervention. Method of measurement: Biodex balance system.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: 1 day before intervention, 1 day after intervention and 14 days after. Method of measurement: Time Up and Go test.</prim_outcome>
      <prim_outcome>Functional balance. Timepoint: 1 day before intervention, 1 day after intervention and 14 days after. Method of measurement: Berg Balance Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscle activity pattern. Timepoint: 1 day before intervention, 1 day after intervention and 14 days after intervention. Method of measurement: Surface electromyography.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-09</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Second Floor, No. 18, Niloufar Alley, Hasht Behesht Sharghi St. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
