<?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>IRCT201307142391N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-08</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of therapeutic exercise in diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of two type of therapeutic exercise Frenkel vs. Swiss ball on the clinical balance indices in patients with diabetes type 2 associated with neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2063</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabete type2.</hc_freetext>
      <i_freetext>Intervention 1: intervention group 1,Swiss ball training:&#13;
balance training in sitting position:&#13;
1- holding balance position on ball&#13;
2- holding balance position on ball with active movements of one sided upper extremity&#13;
3-  holding balance position on ball with active movements of two sided upper extremity&#13;
4-  holding balance position on ball with trunk movements (bending forward and rotation)&#13;
5-  holding balance position on ball with heel raising&#13;
6- holding balance position on ball with toes raising&#13;
7-  holding balance position on ball with raising heel and toes simultaneous&#13;
8- resistance against perturbation&#13;
9- weight shifting on ball&#13;
ball training in standing position:&#13;
1- picking up and down the ball with two upper extremity in a straight line&#13;
2-  picking up and down the ball with two upper extremity in an oblique line&#13;
3- moving the ball forward and backward with left and right lower extremity&#13;
4-  moving the ball in lateral sides with left and right lower extremity &#13;
5- throwing ball toward the wall with hand&#13;
6- throwing ball toward the wall with foot. Intervention 2: control group: clinical balance indices is measured without  intervention. Intervention 3: intervention group 2,Frenkel exercise:&#13;
in supine position:&#13;
1- patient bends one leg at the hip and knee,&#13;
as heel along the bed,Repeats with&#13;
the other leg&#13;
2- Bends one leg at the hip and knee and Then &#13;
 straights his hip and knee to&#13;
return to the starting position. Repeats&#13;
with the other leg&#13;
3- Bends one leg &#13;
with the heel raises from the bed. Repeats with the other leg&#13;
4- Bends  one leg and place it at the at any point of command. Repeats with the other leg&#13;
5- Bends one leg and&#13;
places that heel on the opposite knee &#13;
Then slides her heel down the shin&#13;
to the ankle and back up to his knee and&#13;
Returns to the starting position.repeats with the other leg&#13;
6- Bends both legs and then keeps his ankles&#13;
together Straighten both legs to&#13;
return to starting position&#13;
7- Bend one leg in a&#13;
bicycling motion&#13;
in sitting position:&#13;
1- raises the heel Then&#13;
progress to alternately lifts the&#13;
entire foot and placing the foot&#13;
on the floor upon a traced foot print&#13;
2- Alternately glides the&#13;
foot over the marked cross forward,&#13;
backward and  lateral side&#13;
3- at first rises from the chair, at second&#13;
bends trunk forward then rises the trunk and  Reverses the procedure to sit down&#13;
in standing position:&#13;
1- shifts the weight to the left foot and places the right foot 12 inches to the right and Repeats exercise with the left side&#13;
2- Walks forward between two parallel&#13;
line 14 inches apart placing&#13;
3- Walks forward placing each foot on&#13;
a footprint traced on the floor( Foot&#13;
prints is parallel and 2 inches&#13;
from a center line)&#13;
4- Turns to the right and places at the right toe and rotates the right and places right foot on the floor then rotates the right,repeats to the left&#13;
5- Walks up and down the stairs and Places the right foot on one step and brings the left up beside it.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Rojhani Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Faculty Rehabilitation,Street Abyverdy,Chamran Boulvard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1627 1552</telephone>
        <email>rojhaniz@sums.ac.ir</email>
        <affiliation>Shiraz University Of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Rojhani Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty Of Rehabilitation,Srtreet Abyverdy,Chamran Boulvard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1627 1552</telephone>
        <email>rojhaniz@sums.ac.ir</email>
        <affiliation>Shiraz faculty of rehabilitation</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: diabetic neuropathy type 2 referred from physician ; between 40-65 years old ; with18-30 body mass index should have the score f more than two in Michigan neuropathy test.Exclusion criteria: lower extremity complications such as fracture and dislocation at least during six months ago ; any history of surgical operations in muscles,bones and joints of lower extremity ; pain in ankle and knee joint during test ; musculo-skeletal disorders such as rheumatoid and myopathy ; middle ear and vestibular impairments in the patient self report ; knee joint flextion contracture ; using supportive equipments in gait ; stop intervention more than two days any way ;  cardiovascular problems and hypertension.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group 1,Swiss ball training:&#13;
balance training in sitting position:&#13;
1- holding balance position on ball&#13;
2- holding balance position on ball with active movements of one sided upper extremity&#13;
3-  holding balance position on ball with active movements of two sided upper extremity&#13;
4-  holding balance position on ball with trunk movements (bending forward and rotation)&#13;
5-  holding balance position on ball with heel raising&#13;
6- holding balance position on ball with toes raising&#13;
7-  holding balance position on ball with raising heel and toes simultaneous&#13;
8- resistance against perturbation&#13;
9- weight shifting on ball&#13;
ball training in standing position:&#13;
1- picking up and down the ball with two upper extremity in a straight line&#13;
2-  picking up and down the ball with two upper extremity in an oblique line&#13;
3- moving the ball forward and backward with left and right lower extremity&#13;
4-  moving the ball in lateral sides with left and right lower extremity &#13;
5- throwing ball toward the wall with hand&#13;
6- throwing ball toward the wall with foot</i_keyword>
      <i_keyword>control group: clinical balance indices is measured without  intervention</i_keyword>
      <i_keyword>intervention group 2,Frenkel exercise:&#13;
in supine position:&#13;
1- patient bends one leg at the hip and knee,&#13;
as heel along the bed,Repeats with&#13;
the other leg&#13;
2- Bends one leg at the hip and knee and Then &#13;
 straights his hip and knee to&#13;
return to the starting position. Repeats&#13;
with the other leg&#13;
3- Bends one leg &#13;
with the heel raises from the bed. Repeats with the other leg&#13;
4- Bends  one leg and place it at the at any point of command. Repeats with the other leg&#13;
5- Bends one leg and&#13;
places that heel on the opposite knee &#13;
Then slides her heel down the shin&#13;
to the ankle and back up to his knee and&#13;
Returns to the starting position.repeats with the other leg&#13;
6- Bends both legs and then keeps his ankles&#13;
together Straighten both legs to&#13;
return to starting position&#13;
7- Bend one leg in a&#13;
bicycling motion&#13;
in sitting position:&#13;
1- raises the heel Then&#13;
progress to alternately lifts the&#13;
entire foot and placing the foot&#13;
on the floor upon a traced foot print&#13;
2- Alternately glides the&#13;
foot over the marked cross forward,&#13;
backward and  lateral side&#13;
3- at first rises from the chair, at second&#13;
bends trunk forward then rises the trunk and  Reverses the procedure to sit down&#13;
in standing position:&#13;
1- shifts the weight to the left foot and places the right foot 12 inches to the right and Repeats exercise with the left side&#13;
2- Walks forward between two parallel&#13;
line 14 inches apart placing&#13;
3- Walks forward placing each foot on&#13;
a footprint traced on the floor( Foot&#13;
prints is parallel and 2 inches&#13;
from a center line)&#13;
4- Turns to the right and places at the right toe and rotates the right and places right foot on the floor then rotates the right,repeats to the left&#13;
5- Walks up and down the stairs and Places the right foot on one step and brings the left up beside it.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before intervention,one day after intervantion. Method of measurement: Berg Balance Scale Test,Star excursion Test,time of leg stance.</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 Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-14</approval_date>
        <contact_name>Shiraz University of Medical Science</contact_name>
        <contact_address>Shiraz faculty Rehabilitatin,Abyverdy Street,Chamrac Boulvard Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
