<?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>IRCT20221210056761N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-26</date_registration>
      <primary_sponsor>self</primary_sponsor>
      <public_title>effectiveness of segmental muscle vibration and bimanual task-oriented training in post-stroke patients.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of segmental muscle vibration and bimanual task-oriented training on upper extremities functional ability in poststroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67325</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling is used. Randomization by lottery method. Allocation concealment through sealed envelope. In a bowl, we put closed slips of group A and group B. Participants fulfilling inclusion criteria will randomly pick up groups and then allocated them through sealed envelopes, Blinding description: In this study, the data analyst is kept unaware of the treatment assigned to the experimental group and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: Segmental muscle vibration along with bimanual task-oriented training was prescribed to the participants of this group. Each participant practiced four of the six functional tasks they chose, depending on their preference. All participants performed a 10-minute warmup. Then they practice the selected functional task for 30 minutes. During that 30-minute TOT, there was a 3-minute break after continuous practice every 10 minutes. Group A received the segmental muscle vibrator (SMV) at the end of each TOT session for 5 min. Intervention 2: Control group: Group B received conventional exercise program along with EMS. The conventional exercise program (CEP) included a practice of active movements, active-assisted movements, and passive movements, stretching, strengthening, and coordination exercises to improve the range of motion, muscle strength, and coordination of the affected upper limb.</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>Afifa Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street no 1, House no 116, Village baherwal, Teh Kharian</address>
        <city>kharain</city>
        <country1>Pakistan</country1>
        <zip>50090</zip>
        <telephone>+92 346 5762379</telephone>
        <email>afifatariq186@gmail.com</email>
        <affiliation>The University Of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afifa Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street no 1, House no 116, Village Baherwal, Teh Kharian</address>
        <city>Kharian</city>
        <country1>Pakistan</country1>
        <zip>50090</zip>
        <telephone>+92 346 4762379</telephone>
        <email>afifatariq186@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 30-70 year of age.
Patients with hemiplegic ischemic stroke.
Patients is in the subacute phase after having a stroke (within 1 to 6 months after stroke)
Able to understand and follow instructions
Stable medical conditions</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other neurological disease (e.g. Parkinson`s disease or Alzheimer`s disease)•
Musculoskeletal problems (e.g. carpal tunnel syndrome, tendinitis of the forearm and wrist and recent fracture)
Myopathy (like muscular dystrophy, myasthenia gravis or myotonia)
All type of aphasia.
visual problems that could not be corrected</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: Segmental muscle vibration along with bimanual task-oriented training was prescribed to the participants of this group. Each participant practiced four of the six functional tasks they chose, depending on their preference. All participants performed a 10-minute warmup. Then they practice the selected functional task for 30 minutes. During that 30-minute TOT, there was a 3-minute break after continuous practice every 10 minutes. Group A received the segmental muscle vibrator (SMV) at the end of each TOT session for 5 min.</i_keyword>
      <i_keyword>Control group: Group B received conventional exercise program along with EMS. The conventional exercise program (CEP) included a practice of active movements, active-assisted movements, and passive movements, stretching, strengthening, and coordination exercises to improve the range of motion, muscle strength, and coordination of the affected upper limb.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spasticity. Timepoint: baseline, after 3 weeks and after 6 weeks of intervention. Method of measurement: modified ashworth scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional ability. Timepoint: baseline, after 3 weeks and after 6 weeks. Method of measurement: Wolf motor functional test and ABILHAND questionnaire.</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>self</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-21</approval_date>
        <contact_name>ethical committee of University of Lahore, Gujrat campus.</contact_name>
        <contact_address>The University of Lahore, G.T. Road, adjacent Chenab Bridge, Gujrat, Gujrat Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
