<?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>IRCT20210615051585N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-12</date_registration>
      <primary_sponsor>Shifa Tameer e Millat University</primary_sponsor>
      <public_title>Effects of Balance Training in Stroke Patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Planter Vibrator versus Transcutaneous Electric Nerve Stimulation (TENS) on Balance  Dysfunction in Patient with Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61241</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment was used for treatment using a sealed envelope. For that, 52 sheets of aluminum paper are properly cut. This paper should be double the size of the paper. 26 Sheets of Carbon paper cut into appropriate size according to the paper used. A standard-sized square paper was taken in which group "(Planter vibrator)" was marked. In this way, 26 papers were prepared marked with "(Planter vibrator)" and 26 square-shaped papers marked with "(TENS)". The sheet of paper on which either (Planter vibrator) or (TENS) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (Planter vibrator) or (TENS)) facing the envelope. Then the sheet of Aluminum foil was wrapped on the carbon paper (with folded paper inside). All the above prepared were placed in the envelope (which was completely opaque), the envelope was then sealed. In this way 26 envelops of "(Planter vibrator)" and 26 envelops of "(TENS)" were prepared with a total number of 52 envelopes. These 52 envelopes were then thoroughly shuffled like a deck of cards. The envelopes were then marked with numbers 1-52. Each participant picked the envelope in order from 1-52 and was given an intervention (Planter vibrator or TENS) accordingly, Blinding description: Only the researcher doing the study knows which treatment or intervention the participant is receiving. It makes results less likely to be biased. For that, they received an additional device that is not connected and they feel they are receiving treatment apart from their actual treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke patients with balance dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Planter Vibrator Group: Treatment for 10min 3 sessions per week for 4 weeks along with the conventional therapy was used to avoid spasticity and increase muscular strength. In Planter vibration protocol, patient was either in a standing or sitting position with 90 degrees flexed knee and support with belts and frame to avoid the risk of fall. Intervention 2: Transcutaneous Electric Nerve Stimulation Group: The same conventional physical therapy was given as for planter vibrator group. Patients was also received electrical stimulation via TENS. TENS sessions were applied to the tibial nerve branch of the sciatic nerve of the affected limb on the plantar surface of the foot each one was lasting for 10 minutes with 110Hz frequency 3 times in a day. Patient were received 3 sessions per week for 4 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to Ethical Considerations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Saima Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 8441751</telephone>
        <email>saimaa.gul@gmail.com</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Saima Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 8441751</telephone>
        <email>saimaa.gul@gmail.com</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with diagnosed stroke
Stroke Patients having issues of balance dysfunction who Stands for at least 20 seconds independently
Patient score minimum from 2 on Ashworth scale.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient under the influence of any sedatives
Any other pathological conditions
Malignancy
Multiple sclerosis
Vestibular dysfunction
Suffering from severe visual problem</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar stroke syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Planter Vibrator Group: Treatment for 10min 3 sessions per week for 4 weeks along with the conventional therapy was used to avoid spasticity and increase muscular strength. In Planter vibration protocol, patient was either in a standing or sitting position with 90 degrees flexed knee and support with belts and frame to avoid the risk of fall.</i_keyword>
      <i_keyword>Transcutaneous Electric Nerve Stimulation Group: The same conventional physical therapy was given as for planter vibrator group. Patients was also received electrical stimulation via TENS. TENS sessions were applied to the tibial nerve branch of the sciatic nerve of the affected limb on the plantar surface of the foot each one was lasting for 10 minutes with 110Hz frequency 3 times in a day. Patient were received 3 sessions per week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: At Baseline and after intervention. Method of measurement: Berg balance scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Independence. Timepoint: 4th Week. Method of measurement: Functional Independent Measure.</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>Shifa Tameer e Millat University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-07</approval_date>
        <contact_name>Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital.</contact_name>
        <contact_address>Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University Islamabad Islamabad Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
