<?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>IRCT20220414054537N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-14</date_registration>
      <primary_sponsor>committe Azra Naheed Centre for Research &amp; Development the Superior University</primary_sponsor>
      <public_title>effect of treadmil training alone versus treadmil training with external clues in treatment of parkinsion's</public_title>
      <acronym></acronym>
      <scientific_title>comparsion of the effectiveness of treadmil training alone  versus treadmil training with external clues in improving gait and functional ability in parkinson's patient</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64051</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: participants fullfilling the inclusion and exclusion criteria will be allocated randomology into control group and experimental group.the process of allocation will be concealed from participants and the researcher, Blinding description: in our study we used a blinding protocol in which the outcome assesor is fully blind he didnot have the idea about the intervention being provided to the participants, the this process which mostly used in clinical trials in which the participants, investigators and/or assessors remain ignorant concerning the treatments which participants are receiving.</study_design>
      <phase>1</phase>
      <hc_freetext>Parkinson's disease is a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. As the disease progresses, people may have difficulty walking and talking.</hc_freetext>
      <i_freetext>Intervention group:  Patients in both treatments will complete training sessions over 6 weeks (5 sessions per week) and the patient will assess at base line and then it will asses after 6 week respectively. During the first session, all patients will be trained for 20 minutes at their own pace. All patients will complete at least 30 training sessions over 45 minutes at the last session.               Group 1 (Control group) Group 1 in training session will receive the treadmill training session over 30 minutes.Patients in 1 receive the same treatment protocol in 5 days per week and the this treatment protocol must be continue for 8 weeks.                                                                                                Group 2 (Experimental Group):Group 2 in training session received the treadmill training session over 30 minutes along with the external clues like visual, auditory,etc.In 5 days per week and this treatment protocol must be continuing for 8 weeks..</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:
comparsion of the effectiveness of the treadmil training alone versus treadmil training with external clues in improving the gait and functional ability in parkinsion's patient

When:
data will be availabe on 7 weeks (2022-07-26)

To whom:
not sured but vailable on request

Conditions:
on request

Where to obtain:
o request

How to obtain:
on request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Zohaib Shahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>main riwind road 17 km ,Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 333 6979114</telephone>
        <email>zohaib.rana@superior.edu.pk</email>
        <affiliation>committe Azra Naheed Centre for Research &amp; Development the Superior University ,Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr zohaib Shahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>main riwind road 17 km ,Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 333 6979114</telephone>
        <email>zohaib.rana@Superior.edu.pk</email>
        <affiliation>committe Azra Naheed Centre for Research &amp; Development the Superior University ,Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 50 to 65 years
Male and female both
idiopathic Parkinson’s disease
disease severity of II to V on the Hoehn and Yahr Scale and with minimum assistance and support  required
ability to stand independently and to walk on a treadmill (with body weight support, if required)
sufficient visual capacity to see the cues</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with Parkinson disease wheel-chair bond and bed-ridden
any other neurologic or orthopedic disorder affecting gait and postural stability;
change in medication for the treatment of Parkinson’s disease during the study period
cognitive impairment
severe cardiovascular disorders
vestibular dysfunctions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G00-G99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>https://icd10monitor.com/icd-10-coding-of-parkinson-s-disease-code-carefully/#:~:text=ICD%2D10%2DCM%20Coding%3A,%2C%E2%80%9D%20code%20G20%20is%20listed.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Patients in both treatments will complete training sessions over 6 weeks (5 sessions per week) and the patient will assess at base line and then it will asses after 6 week respectively. During the first session, all patients will be trained for 20 minutes at their own pace. All patients will complete at least 30 training sessions over 45 minutes at the last session.               Group 1 (Control group) Group 1 in training session will receive the treadmill training session over 30 minutes.Patients in 1 receive the same treatment protocol in 5 days per week and the this treatment protocol must be continue for 8 weeks.                                                                                                Group 2 (Experimental Group):Group 2 in training session received the treadmill training session over 30 minutes along with the external clues like visual, auditory,etc.In 5 days per week and this treatment protocol must be continuing for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gait: Gait is the rhythmical movement of the limb and trunks which help in the forward movement of the central of gravity and it help in the shifting of the weight forward.                                                  Gait Cycle: Step Length,.Stride length: Stance phase.Swing phase: mid swing Acceleration,deacceleration.Stance phase divided into 5 major sub-division like:Initial contact: rFoot flat: Mid stance: tHeel off:  Toe off:. Timepoint: after 6 weeks. Method of measurement: wisconsin gait scale for gait measeuremnt and Functional ability will be assessd by Motor Aspects of Experiences of Daily Living (M-EDL).</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>no funding</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-05</approval_date>
        <contact_name>committe Azra Naheed Centre for Research &amp; Development the Superior University ,Lahore</contact_name>
        <contact_address>main riwind road 17 km ,Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
