<?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>IRCT20210615051585N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-11</date_registration>
      <primary_sponsor>Shifa Tameer e Millat University</primary_sponsor>
      <public_title>Effect of Wii-fit based balance training combined with planter cutaneous sensory stimulation in older adults with diabetic neuropathy</public_title>
      <acronym>Balance management in diabetic neuropathy patients (BMDN)</acronym>
      <scientific_title>Effect of Wii-fit based balance training combined with planter cutaneous sensory stimulation in older adults with diabetic neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60219</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: N/A, Randomization description: Random assignment for treatment using sealed envelope 26 Sheets of properly cut Aluminum paper 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 "(Wiifit)" was marked. In this way, 11 papers were prepared marked with "(Wii-fit)" and 11 square-shaped papers marked with "(Wii-fit+SS)". The sheet of paper on which either (Wii-fit) or (Wii-fit + SS) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (Wii-fit) or (Wii-fit + SS)) 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 11 envelops of "(Wii-fit)" and 11 envelops of "(Wii-fit)" were prepared. With a total number of 22 envelopes. These 22 envelopes were then thoroughly shuffled like a deck of cards. The envelopes were then marked with numbers 1-22. Each participant picked the envelope in order from 1-22 and was given an intervention (Wii-fit or Wii-fit) 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic Neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Wii-fit Group: Treatment for 20 min 2 sessions per week for 8 weeks along with the conventional therapy. Conventional therapy includes: passive stretching, repetitive task-specific activities, passive, active-assisted and active ROM exercises. The Wii-fit protocol included using Wii-fit set and the games. The game uses a unique platform peripheral called the Wii Balance Board, on which the player stands during exercise. The Board is not a rocking balance board but a device that tracks the user's center of balance. The patient played each game for 10-mins per session. Intervention 2: Wii-fit+SS Group: The same treatment (as above) given to the participants along with Cutaneous sensory stimulations (10mins) which was given by using flannel cloth and brittle brush.</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 consideration</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>25000</zip>
        <telephone>+92 332 1964158</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>25000</zip>
        <telephone>+92 332 1964158</telephone>
        <email>saimaa.gul@gmail.com</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Older adults age limit between 60-90 years
Diagnosed Diabetes Mellitus for more than 1 year having neuropathy
Both genders. ( Male and Female)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dependence on others to complete activities of daily living
Loss of protective foot sensations
Comorbidities including visual impairment, cerebrovascular accident, Orthopaedic trauma, Labyrinthitis, peripheral vascular disease, Heart failure
Using the assistive device for ambulation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellites with diabetic neuropathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Wii-fit Group: Treatment for 20 min 2 sessions per week for 8 weeks along with the conventional therapy. Conventional therapy includes: passive stretching, repetitive task-specific activities, passive, active-assisted and active ROM exercises. The Wii-fit protocol included using Wii-fit set and the games. The game uses a unique platform peripheral called the Wii Balance Board, on which the player stands during exercise. The Board is not a rocking balance board but a device that tracks the user's center of balance. The patient played each game for 10-mins per session.</i_keyword>
      <i_keyword>Wii-fit+SS Group: The same treatment (as above) given to the participants along with Cutaneous sensory stimulations (10mins) which was given by using flannel cloth and brittle brush</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Baseline, after intervention. Method of measurement: Berg Balance Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To determine balance. Timepoint: 8th week. Method of measurement: secondary outcome was measured by time up and go.</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>2021-06-18</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>
