<?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>IRCT20210814052177N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-16</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effect of task specific training &amp; Rood’s approach on stroke patients.</public_title>
      <acronym></acronym>
      <scientific_title>Combined effect of Task specific training and Rood’s approach to improve motor and sensory arm function in patients with stroke.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58193</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Non probability purposive sampling technique will be  done on the patients  on individual basis. Simple randomization will be done and patients will be allocated to three different groups by lottery method with sealed envelopes  and identical slips of paper, Blinding description: Participants will be blind in the study because treatment will be provided individually and alone. Participants will not know which group they belong to because treatment will be performed by the therapist and will not be explained in detail to the patients. Both techniques will be performed manually and patient will be unaware of the treatment techniques. As both are manual techniques performance of these intervention will be made similar to patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Sensory and motor function of arm in Stroke patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1 will receive common treatment and Rood’s treatment approach for  three times a week on alternate days, for six weeks. Rood's approach include:	Tapping (over the arm muscle to be facilitated,3-5 times per repetition, 10 repetitions per day, 3days/ week) •	Icing (3-5 sec/ repetition, 10 repetitions/day, 3days/week).•	Fast brushing (Apply for 3 to 5seconds &amp; repeated after 30 sec, 10 repetitions/day).•	Light touch (3-5 strokes/repetition, 30 sec rest period between strokes, 10 repetitions/day).•	Heavy joint compression (Joint Compression &gt;body	wt. applied through the longitudinal axis of the bone.). Intervention 2: Intervention group: Intervention group 2 will be subjected to task specific training along with common treatment for 45 minutes, three  times a week for six weeks. Task specific training involve 20-30 trials of each activity. Touch a wall at shoulder level•	Touch his cheeks and hair•	Slide a ball with extensor effect of  forearm•	Reach activities•	Reaching out toward a jar•	Driving the wrist/finger extensors to open the paretic hand.•	Grabbing the jar•	Grasp a ball. Intervention 3: Intervention group: Intervention group 3 will receive combination of both Rood’s approach and Task specific training along with common treatment.  Rood's approach include:	Tapping (over the arm muscle to be facilitated,3-5 times per repetition, 10 repetitions per day, 3days/ week) •	Icing (3-5 sec/ repetition, 10 repetitions/day, 3days/week).•	Fast brushing (Apply for 3 to 5seconds &amp; repeated after 30 sec, 10 repetitions/day).•	Light touch (3-5 strokes/repetition, 30 sec rest period between strokes, 10 repetitions/day).•	Heavy joint compression (Joint Compression &gt;body	wt. applied through the longitudinal axis of the bone). Task specific training involve 20-30 trials of each activity. Touch a wall at shoulder level•	Touch his cheeks and hair•	Slide a ball with extensor effect of  forearm•	Reach activities•	Reaching out toward a jar•	Driving the wrist/finger extensors to open the paretic hand.•	Grabbing the jar•	Grasp a ball.</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 I take consent from patients that i will not share their information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maham Saleem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P720 neelam street green view colony Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 320 7033581</telephone>
        <email>mahamsaleem114@gmail.com</email>
        <affiliation>Faisalabad institute of management and Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maham Saleem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P720 neelam street green view colony Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 320 7033581</telephone>
        <email>mahamsaleem114@gmail.com</email>
        <affiliation>Faisalabad institute of management and Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 45-65
Acute &lt;6 months upper extremity paresis after stroke.
Muscle power 0-3 muscle grade of all muscle of upper limb by MMT according to oxford scale
Time since stroke &lt; 6months.
Sufficient cognitive ability to participate
Both genders
Before stroke they were able to wash their hands and feed themselves.
Had no premorbid severe arm condition before stroke</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncontrolled Hypertension.
Severe dysphasia
Occipital/ cerebellar lesion
Other neurological, neuromuscular or orthopedic lesion.
Concurrent participation in other upper extremity stroke treatment
Perceptual, apraxic or major cognitive defects.
Arm contracture
Severe comorbidity.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1 will receive common treatment and Rood’s treatment approach for  three times a week on alternate days, for six weeks. Rood's approach include:	Tapping (over the arm muscle to be facilitated,3-5 times per repetition, 10 repetitions per day, 3days/ week) •	Icing (3-5 sec/ repetition, 10 repetitions/day, 3days/week).•	Fast brushing (Apply for 3 to 5seconds &amp; repeated after 30 sec, 10 repetitions/day).•	Light touch (3-5 strokes/repetition, 30 sec rest period between strokes, 10 repetitions/day).•	Heavy joint compression (Joint Compression &gt;body	wt. applied through the longitudinal axis of the bone.)</i_keyword>
      <i_keyword>Intervention group: Intervention group 2 will be subjected to task specific training along with common treatment for 45 minutes, three  times a week for six weeks. Task specific training involve 20-30 trials of each activity. Touch a wall at shoulder level•	Touch his cheeks and hair•	Slide a ball with extensor effect of  forearm•	Reach activities•	Reaching out toward a jar•	Driving the wrist/finger extensors to open the paretic hand.•	Grabbing the jar•	Grasp a ball</i_keyword>
      <i_keyword>Intervention group: Intervention group 3 will receive combination of both Rood’s approach and Task specific training along with common treatment.  Rood's approach include:	Tapping (over the arm muscle to be facilitated,3-5 times per repetition, 10 repetitions per day, 3days/ week) •	Icing (3-5 sec/ repetition, 10 repetitions/day, 3days/week).•	Fast brushing (Apply for 3 to 5seconds &amp; repeated after 30 sec, 10 repetitions/day).•	Light touch (3-5 strokes/repetition, 30 sec rest period between strokes, 10 repetitions/day).•	Heavy joint compression (Joint Compression &gt;body	wt. applied through the longitudinal axis of the bone). Task specific training involve 20-30 trials of each activity. Touch a wall at shoulder level•	Touch his cheeks and hair•	Slide a ball with extensor effect of  forearm•	Reach activities•	Reaching out toward a jar•	Driving the wrist/finger extensors to open the paretic hand.•	Grabbing the jar•	Grasp a ball</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sensory  function of arm. Timepoint: Before intervention and after six week of intervention. Method of measurement: Fugl meyer assessment scale.</prim_outcome>
      <prim_outcome>Motor function of arm. Timepoint: Before intervention and after six week of intervention. Method of measurement: Fugl meyer assessment scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spasticity of arm muscle. Timepoint: Before intervention and after six week of intervention. Method of measurement: Modified ashworth scale.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-25</approval_date>
        <contact_name>Ethics committee of The University of Faisalabad</contact_name>
        <contact_address>P720 neelam street green view colony Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
