<?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>IRCT2017090836095N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-07</date_registration>
      <primary_sponsor>Vice Chancellor for Research of deputy of School of Physical Education, Kharazmi University of Tehra</primary_sponsor>
      <public_title>Effect 12 weeks group progressive resistance exercise with musical background on gross motor  function and Participation in activity sports children with cerebral palsy of spastic</public_title>
      <acronym></acronym>
      <scientific_title>Effect 12 weeks group progressive resistance exercise with musical background on gross motor function and Participation in activity sports children with cerebral palsy of spastic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: The training program includes 12 weeks, 3 sessions per week and 60 minutes per session (with a rest day between each training session). The training program included 10 minutes of warming and stretching, 40 minutes of  exercise and 10 minutes of cool and tensile style movements. The amount of exercise load (severity) increased  gradually based on the ability of individuals. In this study, the principles of increasing NCSA and ASCM resistance training were used. In order to get the weight of the training, the participants was initially weared a  body vest and Foot lift, with the weight of half and a kilogram in front and back equal in this vest. In order to determine the amount of exercise load, the child started with 6 repetitions with a weight of less than one maximum repetition and based on the number of repetitions and based on the weight of the carried amount was calculated a maximum repetition . Ressistance  training is performed in a group with exciting and motivational music such as disco, rock, pop, which is common in gym clubs. An exciting, fast-paced music with loud rhythm patterns and temptations ranging from 124 to 128 bpm (multiples per minute) was used to increase the children's stimulus and excitement to further engaging in exercises. The exercise was conducted by the leader of the group and gave the members of the group instructions for modifying movements and increasing motivation. The coach encouraged the participants to participate more during the session, and at the end of each week the training would also be awards for the participants. Intervention 2: Control group: The control group received only ordinary daily care and did not participate in any resistance training program during 12 weeks. No intervention was performed on them.</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>Hamid Reza Sajjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti St, Hesarak Sqare, Alborz, Iran. Motor Behavior Department, Physical Education Faculty, Kharazmi University</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7419113413</zip>
        <telephone>+98 71 5241 7410</telephone>
        <email>Hamidrezasajadi83@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Sajjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti St, Hesarak Sqare, Alborz, Iran. Motor Behavior Department, Physical Education Faculty, Kharazmi University</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>03197937551</zip>
        <telephone>+98 71 5241 7410</telephone>
        <email>Hamidrezasajadi83@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The criteria for entering the study include: 1- Spastic diplegia cerebral palsy; 2- Ability to stand and walk independently at home or without auxiliary equipment (children at the level of GMFCS I-III); 3. No obvious limitation in the lower limb's passive range; - Ability to understand commands and collaboration during the test. Exit criteria include: 1- Any illnesses such as heart disease, diabetes, seizure, etc. 2- Any deformity fixed in the lower extremity; 3. Orthopedic surgery and botulinum toxin injection in the 6 months before the intervention (or Scheduled form during the study); 4) failure to exercise strength for at least 3 months before the intervention; 5) use of medications that may affect muscle tone or strength; 6) the occurrence of orthopedic events during the study; And 7. The lack of cooperation between children and parents.</inclusion_criteria>
      <agemin>85 years</agemin>
      <agemax>79 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G00-G99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nervous system disease (tremor, neurological discomfort, flea ...)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The training program includes 12 weeks, 3 sessions per week and 60 minutes per session (with a rest day between each training session). The training program included 10 minutes of warming and stretching, 40 minutes of  exercise and 10 minutes of cool and tensile style movements. The amount of exercise load (severity) increased  gradually based on the ability of individuals. In this study, the principles of increasing NCSA and ASCM resistance training were used. In order to get the weight of the training, the participants was initially weared a  body vest and Foot lift, with the weight of half and a kilogram in front and back equal in this vest. In order to determine the amount of exercise load, the child started with 6 repetitions with a weight of less than one maximum repetition and based on the number of repetitions and based on the weight of the carried amount was calculated a maximum repetition . Ressistance  training is performed in a group with exciting and motivational music such as disco, rock, pop, which is common in gym clubs. An exciting, fast-paced music with loud rhythm patterns and temptations ranging from 124 to 128 bpm (multiples per minute) was used to increase the children's stimulus and excitement to further engaging in exercises. The exercise was conducted by the leader of the group and gave the members of the group instructions for modifying movements and increasing motivation. The coach encouraged the participants to participate more during the session, and at the end of each week the training would also be awards for the participants.</i_keyword>
      <i_keyword>Control group: The control group received only ordinary daily care and did not participate in any resistance training program during 12 weeks. No intervention was performed on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gross motor function. Timepoint: After 12 weeks. Method of measurement: with gross motor function test (GMFM-66).</prim_outcome>
      <prim_outcome>Participation in activity sports. Timepoint: After 12 weeks. Method of measurement: with The Children's Assessment of Participation and Enjoyment questionnaire (CAPE).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ability to walk fast. Timepoint: After the end of 12 weeks. Method of measurement: 1-Minute fast walk test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Department of Welfare of Alborz Province</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 deputy of School of Physical Education, Kharazmi University of Tehra</source_name>
      <source_name>Department of Welfare of Alborz Province</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-06</approval_date>
        <contact_name>Ethics Committee, Faculty of Physical Education, Kharazmi University of Tehran</contact_name>
        <contact_address>Shahid Beheshti St, Hesarak Sqare, Alborz, Iran. Motor Behavior Department, Physical Education Faculty, Kharazmi University karaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
