<?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>IRCT20200316046791N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-01</date_registration>
      <primary_sponsor>Isra University</primary_sponsor>
      <public_title>Comparison of Mirror Therapy and Motor Relearning program in stroke.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Mirror Therapy and Motor Relearning program in improving the motor function of patients with stroke.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2641-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/46666</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: The subjects fulfilling the inclusion criteria will be enrolled .For the purpose of randomisation first adequate generation of the allocation sequence and then Concealment of the allocation sequence will be done until assignment occurs.The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminum foil inside the envelope will be used to render the envelope impermeable to intense light. To prevent subversion of the allocation sequence, the name and date of birth of the participant will be written on the envelope and a video tape made of the sealed envelope with participant details visible. Carbon paper inside the envelope transferred the information onto the allocation card inside the envelope and a second researcher (outcome assessor) later view video tapes to ensure envelopes were still sealed when participants' names were written on them. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments and it will be time to allocate the intervention.", Blinding description: It will be single blind and assessor will be blind .All assessments before and after the intervention will be performed by Independent assessor and only eligible subjects will be enrolled . Motor function,joint ROM,balance will be measured.Then subjects will be kept confidential and only it will be given after the assessor has completed an assessment at baseline , after 03 weeks and 06weeks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Treatment Group :Motor Relearning Program:5 sessions a week for 6 weeks.Duration of session will be 40 minutes.(In this intervention emphasis is placed on; utilizing theories of learning and knowledge of bio mechanics for analyzing movements and performance of task.It is based on the assumption that the impaired learning the same way as the unimpaired. Program is based on four factors 1.Elimination of unnecessary muscle activity 2.Feedback 3.Practice 4.Link between postural adjustment and movement,Improve sitting down and standing up,Balance standing: 5.Gait 6.Spasticity 7.Sensory problems). Intervention 2: Control Group:Mirror Therapy:5 sessions a week for 6 weeks.Duration of session will be 40 minutes.(For mirror therapy the size of mirror will be 35 x 25 inches.Basic motor exercises according to the available function of the patient.Functional tasks or exercises will be performed.</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:
Comparison of mirror therapy and motor relearning program in stroke.

When:
It will be available after study completion

To whom:
To researchers for study only.Patient data will not be shown .

Conditions:
To researchers for study only.Patient data will not be shown .

Where to obtain:
From the University office and Responsible supervisor and from journal we will process in future

How to obtain:
It will be only used in confidential way for improving research and benefit of humanity

Comments:
It will be first study of such type in Pakistan involving the Upper and Lower limb for comparing the effects of mirror therapy and motor relearning program in stroke.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rabia Rauf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gulshan e usman rahim yar khan</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>092685886995</telephone>
        <email>rabiarauf007@gmail.com</email>
        <affiliation>Royal College of physiotherapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rabia Rauf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gulshn e Usman Rahim yar khan</address>
        <city>Rahim Yar Khan</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>092685886995</telephone>
        <email>rabiarauf007@gmail.com</email>
        <affiliation>Royal college of physiotherapy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 40 to 65 years
Both ischemic and hemorrhagic stroke
Both male and female will be included
Must have intact/unaffected extremity</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are not medically stable
Patients who have dementia
Other musculoskeletal, vascular related conditions, impaired cognitive functions.
Rare cardiac diseases
Progressive Neurological disorder
Orthopedic disorder involving any joint of limbs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Treatment Group :Motor Relearning Program:5 sessions a week for 6 weeks.Duration of session will be 40 minutes.(In this intervention emphasis is placed on; utilizing theories of learning and knowledge of bio mechanics for analyzing movements and performance of task.It is based on the assumption that the impaired learning the same way as the unimpaired. Program is based on four factors 1.Elimination of unnecessary muscle activity 2.Feedback 3.Practice 4.Link between postural adjustment and movement,Improve sitting down and standing up,Balance standing: 5.Gait 6.Spasticity 7.Sensory problems)</i_keyword>
      <i_keyword>Control Group:Mirror Therapy:5 sessions a week for 6 weeks.Duration of session will be 40 minutes.(For mirror therapy the size of mirror will be 35 x 25 inches.Basic motor exercises according to the available function of the patient.Functional tasks or exercises will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor function. Timepoint: on baseline ,then after 3 weeks and then after 6 weeks. Method of measurement: Motor Part of Fugl meyer assessment scale of Upper and Lower extremity.</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>Academic support only</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2641-04-18</approval_date>
        <contact_name>Advance Studies and Research Committee(ASRC)</contact_name>
        <contact_address>Farash town near sultana foundation lehtrar road islamabad Islamabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
