<?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>IRCT20230723058901N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-06</date_registration>
      <primary_sponsor>THQ Civil Hospital</primary_sponsor>
      <public_title>Effects of action observation therapy on freezing of gait and functional mobility in patients with Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>Effects of routine physical therapy with and without action observation therapy on freezing of gait and functional mobility in patients with parkinson’s disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>21</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71550</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Time up and go test for functional mobility and freezing of gait(FOG) questionnaire to assess freezing of gait, Randomization description: Randomization in this study was conducted using a computer-generated randomization method. The unit of randomization was at the individual level, where each participant was assigned to one of two groups. The random sequence was constructed using specialized software designed for randomization purposes. Allocation concealment was rigorously carried out through the use of opaque sealed envelopes. These envelopes were prepared in advance and remained sealed until each participant's allocation decision was made, Blinding description: The study was single blinded the outcome assessor didn’t know while they were receiving experimental or conventional treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group patient were treated with routine physical therapy. The exercise program consists of stretching, strengthening and isometric exercise based on the severity of functional mobility and freezing of Gait. According to the patient‘s physical condition, the therapist conducted each treatment for 45 minutes, once a day, 5 times a week, for a total of12 weeks. Intervention 2: Intervention group: In this group patient were treated with action observation therapy (AOT) as well as with routine physical therapy (RPT).To reduce the aspects of freezing of gait, the tasks were assigned to the persons who took participate in the daily sessions of thirty minutes twice a day. These aspects include ankle tapping, taking back and forth steps and counting the steps during walk. In these sessions, the patient was asked to follow every step and movement of therapist.</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:
Demographic data and data related to final outcome will be shared by maintaining the confidentiality.

When:
Data will be available from April 2024 to June 2024 after the six months of Publication. The data sharing plan for the clinical trial(i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trial registry platform , this occur before the first participant is enrolled.

To whom:
Dr Kiran Maqsood( Corresponding Author )

Conditions:
For Research Purpose

Where to obtain:
To the Corresponding Author of the study; dr Kiran Maqsood and can contact on +923239578501, Kiranfaryal555@gmail.com can visit the search engines, you can find my study data will be available from April 2024 to June 2024 after six months of publication. The data sharing plan for the clinical trial(i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trial registry platform , this occur before the first participant is enrolled.

How to obtain:
Open Access and there is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by director in charge and in case of eligibility, it would be shared in two weeks.

Comments:
I want randomized clinical trial registration.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ayesha jamil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk</address>
        <city>Daska</city>
        <country1>Pakistan</country1>
        <zip>51010</zip>
        <telephone>+9233244481031</telephone>
        <email>Ayesha.jamil@uipt.uol.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ayesha jamil</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54590</zip>
        <telephone>+92 324 4481031</telephone>
        <email>Ayesha.jamil@uipt.uol.edu.pk</email>
        <affiliation>University Of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>participants with clinical diagnosis of PD according to UK Parkinson's Disease Society Brain Bank criteria
Age between 50 to 80
In order to select PD subjects for those FoG severely impacted gait, patients were enrolled ifthe occurance of freezing was at least once a week (minimum score of 1 on item 2 in the new FoG Questionnaire (FoG-Q)) and the longest episodes was &gt; 2 seconds (minimum score of 2 on item 4 of the FoG-Q
Hoehn &amp; Yahr (H&amp;Y) stage ≤ 3</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>medical illnesses or substance abuse that could interfere with cognition; any (other) major systemic or neurological illness.
implantation for deep brain stimulation
cognitive impairment, in particular patients with a Minimental State Examination (MMSE)score &lt; 24
visual or acoustic limitations</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group patient were treated with routine physical therapy. The exercise program consists of stretching, strengthening and isometric exercise based on the severity of functional mobility and freezing of Gait. According to the patient‘s physical condition, the therapist conducted each treatment for 45 minutes, once a day, 5 times a week, for a total of12 weeks.</i_keyword>
      <i_keyword>Intervention group: In this group patient were treated with action observation therapy (AOT) as well as with routine physical therapy (RPT).To reduce the aspects of freezing of gait, the tasks were assigned to the persons who took participate in the daily sessions of thirty minutes twice a day. These aspects include ankle tapping, taking back and forth steps and counting the steps during walk. In these sessions, the patient was asked to follow every step and movement of therapist</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Freezing of gait. Timepoint: at baseline week 6 and week 12. Method of measurement: FOG (freezing of gait questionnaire).</prim_outcome>
      <prim_outcome>Functional Mobility. Timepoint: at baseline week 6 and week 12. Method of measurement: TUG (Time Up and Go test).</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>University Of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-22</approval_date>
        <contact_name>Research Ethical Committee, Faculty of Allied Health Sciences, The University of Lahore</contact_name>
        <contact_address>-Km Defence Road،, near Bhuptian Chowk،, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
