<?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>IRCT20210818052225N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-22</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effects of Proprioceptive Training and Partial Body Weight Supported Treadmill Training on Balance and Functional Mobility in Children with Spastic Diplegia: A Randomized Controlled Trial.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Proprioceptive Training and Partial Body Weight Supported Treadmill Training on Balance and Functional Mobility in Children with Spastic Diplegia: A Randomized Controlled Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized controlled study design, Randomization description: After fulfilling the inclusion criteria patients were divided randomly into experimental and control group. Patients were randomized individually. They were distributed by random numbers. Allocation was concealed in envelops. Researcher was unaware of treatment given to patients, Blinding description: Assessor was unaware about the patients from both groups. He was allowed to assess data before giving intervention and after the complete duration of twelve weeks. He was unaware of treatment given to participants.</study_design>
      <phase>2</phase>
      <hc_freetext>Spastic diplegic cerebral palsy.</hc_freetext>
      <i_freetext>Intervention 1: Participants in control group were practiced proprioceptive training with specialized proprioceptive exercises. 1: Stair climbing up and down (regular 3 steps staircase).2: Standing with feet approximately shoulder-width apart with arm extending lower than shoulder then lifting the both heels from the floor an d maintain for 10 sec, followed by climbing regular steps3: One foot placed on inside of the opposing ankle and hold the position for 10 sec followed by climbing regular steps staircase.4: One leg standing with one foot raised to back and maintain this position for minimum 3 seconds. This procedure is performed with eyes closed also.5: Same procedure as described above with one foot raised to the front.6: Walking heel to toes.7: Rising from a standard chair 4 times without support.                                                                                                                                             All proprioceptive exercises was performed for 30 minutes per session with 5 minutes rest period in between for 3 days a week and continued for 12 weeks. Intervention 2: Patients were treated with proprioceptive exercises in addition of treadmill training program which was conducted 3 times/week for 12 successive weeks. Patients practiced one hour session of treatment including 30 minutes of Proprioceptive training and 30 minutes of treadmill training. A specialized Harness was used with treadmill training to ensure safety of a patient. After Proprioceptive exercises treadmill training subdivided into 3 sets with 10 minutes each. During first and last 5 minutes, child walked at 60% maximal speed while during remaining 20 minutes, they performed walking at 80% maximal speed. 5 min rest after each set of training to prevent fatigue. Treadmill speed started at 0.5 km/h~1.0 km/h and increased gradually according to children’s adaptability by 0.1 km/ h progressively to suit the child’s speed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Benish Shakoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>west canal road, alnoor block, house # p109, Faisal Garden phase 1, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8756972</telephone>
        <email>benishshakoor@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Benish Shakoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West canal road, Alnoor block, house # p109, Faisal Garden phase 1, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 332 1483575</telephone>
        <email>benishshakoor294@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Spastic diplegic cerebral palsy                                                                                               •
Both gender
11-13 years old
Spasticity of grade &lt;2 according to the Modified Ashworth Scale
Level II-III (Gross Motor Functional Classification System)
Intact cognitive status (Mini Mental State Examination, level 9-20 will be included )
Normal Vision and hearing status.</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Seizures
Patients who had gone through any surgical procedure related to spine and extremities 6 months ago
Patients with fixed Joint contractures
Bony deformity i.e. Scoliosis, windswept deformity, crouch knee deformity, Rocker Bottom deformity etc.
Multiple medical concerns i.e. Any Cardiac issue and Asthma etc.•
Medicines to reduce spasticity
Patients already involve in Treadmill training at home</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic diplegic cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Participants in control group were practiced proprioceptive training with specialized proprioceptive exercises. 1: Stair climbing up and down (regular 3 steps staircase).2: Standing with feet approximately shoulder-width apart with arm extending lower than shoulder then lifting the both heels from the floor an d maintain for 10 sec, followed by climbing regular steps3: One foot placed on inside of the opposing ankle and hold the position for 10 sec followed by climbing regular steps staircase.4: One leg standing with one foot raised to back and maintain this position for minimum 3 seconds. This procedure is performed with eyes closed also.5: Same procedure as described above with one foot raised to the front.6: Walking heel to toes.7: Rising from a standard chair 4 times without support.                                                                                                                                             All proprioceptive exercises was performed for 30 minutes per session with 5 minutes rest period in between for 3 days a week and continued for 12 weeks.</i_keyword>
      <i_keyword>Patients were treated with proprioceptive exercises in addition of treadmill training program which was conducted 3 times/week for 12 successive weeks. Patients practiced one hour session of treatment including 30 minutes of Proprioceptive training and 30 minutes of treadmill training. A specialized Harness was used with treadmill training to ensure safety of a patient. After Proprioceptive exercises treadmill training subdivided into 3 sets with 10 minutes each. During first and last 5 minutes, child walked at 60% maximal speed while during remaining 20 minutes, they performed walking at 80% maximal speed. 5 min rest after each set of training to prevent fatigue. Treadmill speed started at 0.5 km/h~1.0 km/h and increased gradually according to children’s adaptability by 0.1 km/ h progressively to suit the child’s speed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: before intervention and after twelve weeks of intervention. Method of measurement: Pediatric Balance scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional mobility. Timepoint: Before intervention and after 12 weeks of intervention. Method of measurement: Timed Up and Go Test (TUG) was used to measure functional mobility.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-03</approval_date>
        <contact_name>Institutional Review of Board of University of Lahore</contact_name>
        <contact_address>Defence road Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
