<?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>IRCT20240911063011N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-18</date_registration>
      <primary_sponsor>Razi University of Kermanshah</primary_sponsor>
      <public_title>The Effect of Close Kinetic Chain Exercises Following Seven Consecutive Sessions of Non-Invasive Brain Stimulation (tDCS vs. tPCS) on Pain, Balance, Movement Function of Women Affected by Knee Osteoarthritis in Kermanshah Province.</public_title>
      <acronym>KKOAK</acronym>
      <scientific_title>The Effect of Close Kinetic Chain Exercises Following Seven Consecutive Sessions of Non-Invasive Brain Stimulation (tDCS vs. tPCS) on Pain, Balance, Movement Function of Women Affected by Knee Osteoarthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79609</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Statistical sample based on G.Power software version 3.1 with error level (α) of 0.05 for statistical tests of two domains, statistical power (β-1) of 0.80 and effect size reported by Studies for the effectiveness of exercise therapy and training have reported from 0.3 to 0.6 for pain and function[76], where 0.5 was considered as the effect size. Therefore, the number of selected samples for the statistical test of covariance, where the pre-tests are considered as covariance variables, was estimated to be 42 people, which was determined by considering the attrition of 45 people. Subjects were randomized by Random Allocation software into groups: 12 sessions of closed motor chain exercises followed by seven consecutive sessions of non-invasive brain stimulation (tDCS), 12 sessions of closed motor chain exercises followed by seven consecutive sessions of non-invasive brain stimulation (tDCS). tPCS) and 12 sessions of closed motor chain exercises will be assigned following seven sessions of consecutive non-invasive brain stimulation (sham), Blinding description: The arrangements considered for this study are two-way blind. So that by applying non-invasive stimulations by a person not involved in the research, the evaluator will not have any knowledge about the type of electrical stimulation intervention assigned to the groups, and the subjects will not know about the differences applied in the type of stimulation of the groups. parallels will be unaware, so that they will receive the stimulation in the first 30 seconds and will be gradually cut off; Also, it will be possible to keep the person who will analyze the data about the groups and exercises assigned to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Non-invasive transcranial stimulation device (TPCS) with a current of 1.5 mA for 15 minutes+Closed kinetic chain exercises. Intervention 2: Intervention group: non-invasive transcranial stimulation device (tdcs) with a current of 2  milliamps for  to 20 minutes+Closed kinetic chain exercises. Intervention 3: Control group: Closed kinetic chain 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Studying the effects of closed motor chain exercises following seven consecutive sessions of non-invasive brain stimulation (tDCS versus tPCS) on pain, balance and motor function of women with knee osteoarthritis in Kermanshah.

When:
6 months after the results are published

To whom:
Masters and PhD students in corrective movements

Conditions:
In order to be used in the field of rehabilitation and its promotion

Where to obtain:
Razi University of Kermanshah - Faculty of Sports Sciences, Dr. Farzaneh Gandami

How to obtain:
Maximum 3 months after application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Gandomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah - Taqbestan Blvd - Silk Garden - Razi University</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۷۱۴۴۱۴۹۷۱</zip>
        <telephone>+98 83 3434 3515</telephone>
        <email>gandomi777@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Afrasiaby</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kermanshah - Elahia, Resalat Square, 20 meters of Nahalestan St., Koi 16, No. 14</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719413331</zip>
        <telephone>+98 83 3724 3181</telephone>
        <email>n.afrasiaby9974@gmail.com</email>
        <affiliation>Razi University of Kermanshah</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• Having the clinical criteria of knee osteoarthritis of the American College of Rheumatology. (Altamn et al., 1991)
• Having II score ≤ in the Kellgren and Lawrence criteria.
• Not using intra-articular injections during the last 3 months.
• Chronic knee pain most days, for at least 3 months, pain score of at least 4 on the visual analogue pain scale.
• Reduction of joint space or osteophyte in radiography.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>• Uncontrolled diabetes.
• Body mass index greater than or equal to (BMI&gt;40kg/m2), patients with extreme obesity.
• Physiotherapy or knee surgery (within the last 12 months).
• Lower limb arthroplasty.
• Intra-articular steroid injections (during the last 6 months).
• Systemic arthritic disease.
• Additional orthopedic injuries in the lower limb (such as joint dysplasia).
• Neuromuscular disorders that interfere with daily functioning such as (stroke, uncontrolled muscle stiffness, tumor,...) patients who are unable to walk without assistive devices.
• Patients who have undergone other exercise or nutritional treatments in the last three months.
• Neuromuscular diseases (such as MS and Parkinson's) that interfere with the training program.
• Fracture and surgery in the lower limb.
• Use of any other therapeutic intervention during the period that the subjects are in the study.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Non-invasive transcranial stimulation device (TPCS) with a current of 1.5 mA for 15 minutes+Closed kinetic chain exercises</i_keyword>
      <i_keyword>Intervention group: non-invasive transcranial stimulation device (tdcs) with a current of 2  milliamps for  to 20 minutes+Closed kinetic chain exercises</i_keyword>
      <i_keyword>Control group: Closed kinetic chain exercises</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: visual analog scale.</prim_outcome>
      <prim_outcome>Degree of perceived fatigue. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: Borg CR10 Index.</prim_outcome>
      <prim_outcome>Physical performance. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: WOMAC questionnaire.</prim_outcome>
      <prim_outcome>Proprioception. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: Bubble Inclinometer.</prim_outcome>
      <prim_outcome>Balance. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: PT-SCAN.</prim_outcome>
      <prim_outcome>Strength. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: dynamometer.</prim_outcome>
      <prim_outcome>Electrical activity of the quadriceps muscles. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: Electromyography.</prim_outcome>
      <prim_outcome>Knee instability. Timepoint: At baseline (before the intervention) and 30 days after the intervention. Method of measurement: Felson questionnaire.</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>Razi University of Kermanshah</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-15</approval_date>
        <contact_name>Ethics Committee of Razi University of Kermanshah</contact_name>
        <contact_address>Kermanshah, Elahia, Resalat Square, 20 meters Nahalistan St., Koi 16, No. 14 Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
