<?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>IRCT20250103064262N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-30</date_registration>
      <primary_sponsor>Riphah International university</primary_sponsor>
      <public_title>Comparison of effects of whole body vibration and PNF techniques on pain, sensorimotor function and balance in diabetic peripheral neuropathy</public_title>
      <acronym>PNF(proprioceptive neuromuscular facilitation)</acronym>
      <scientific_title>Comparative effects of Whole-body vibration and PNF techniques on pain,sensorimotor function and balance in diabetic peripheral neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81143</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Neuropathic pain, sensorimotor functions, balance , diabetic neuropathy, Randomization description: This study will be a randomized clinical trial. A total of 36 patients will be recruited according to the inclusion and exclusion criteria according to convenience sampling into two intervention groups. Patients will be divided into Group A(n=18) and Group B(n=18). Group A will recieve Whole-body vibration therapy and Group B will recieve PNF techniques with conventional treatment. All participants will receive interventions for 35-40 mintues per session, three times a week for eight weeks. For pre and post evaluation of all participants Berg Balance Scale, LANSS scale and Numeric pain rating scale will be used. Data will analysed by using SPSS (statistical package for social sciences) 23 version, Blinding description: This study employes a single-blinded design, where participants are unaware of their treatment allocation. Participants are randomly assigned to either the Whole-body vibration group or the proprioceptive neuromuscular facilitation PNF technique group. The researcher knows which treatment each participant receives but will use standardized tools to assess outcomes and minimize bias. This design helps ensure the study results are reliable and accurate.</study_design>
      <phase>2</phase>
      <hc_freetext>Diabetes Mellitus is a serious health disease that causes a person's blood sugar level to be high. It happens when your body cannot make enough insulin or does not respond to the insulin in the body. The most common and serious complication of diabetes mellitus is diabetic peripheral neuropathy in whic the nerves in the peripheries get damaged and produce symptoms like pain, numbness, tingling and burning sensations.The prevalance of diabetic neuropathy is between 6% to 51% in older adults depending on age, duration and sugar level control..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention group is divided into two groups. Group A will receive whole-body vibration technique in which we will use a whole-body vibration machine. the participants will stand on the vibrating platform to receive vibrational stimulation. Intervention 2: Intervention group: the Group B will receive PNF technique in which Diagonal patterns will be used where the therapist will move the participants' limbs through diagonal patterns helping to improve proprioception and neuromuscular control.</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:
Comparative effects of whole-body vibration and PNF techniques on pain,sensorimotor function and balance in diabetic peripheral neuropathy

When:
The data will become available from May 2025 to May 2026

To whom:
The data will be availabe to the researchers and analysts for legitimate research purposes

Conditions:
The deidentifed IPD set can be used for research purposes, academic purpose(e.g thesis, assigments),presentation at scientific conferences

Where to obtain:
talhaalibaig786@gmail.com

How to obtain:
Contact the authorised person

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Sana Riaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza Saeed Rd block M Gulberg 3 lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+92 347 4716107</telephone>
        <email>sana.rcrs@riphah.edu.pk</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sana Riaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>25 Raza Street Rd Block M Gulberg 3 lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+92 347 4716107</telephone>
        <email>sana.rcrs@riphah.edu.pk</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>HbA1c level should be &gt;154ml/dL
Both genders
Age between 45 to 60 years
Presence of sensorimotor dysfunction including pain and numbness
&lt;45 score of berg balance score
Patient should be able to comprehend and fulfill the command
Pain persisting fom 4 to 6 weeks
Non-pregnant adults</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with cardiac conditon
Depression that needs treatment
High surgical risks
Diabetic ulcers
Neuropathic pain other than included in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with diabetic polyneuropathy</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: the intervention group is divided into two groups. Group A will receive whole-body vibration technique in which we will use a whole-body vibration machine. the participants will stand on the vibrating platform to receive vibrational stimulation</i_keyword>
      <i_keyword>Intervention group: the Group B will receive PNF technique in which Diagonal patterns will be used where the therapist will move the participants' limbs through diagonal patterns helping to improve proprioception and neuromuscular control</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain reduction. Timepoint: Before intervention and 2,4 and 8th week and after intervention. Method of measurement: Numeric pain rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance  improvement. Timepoint: 2, 4 and 6 week. Method of measurement: Berg balance score.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>81143</sec_id>
        <issuing_authority>Comparative effects of Whole-body vibration and PNF techniques on pain,sensorimotor fucntions and balance in diabetic peripheral neuropathy</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Riphah International university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-24</approval_date>
        <contact_name>Reseach Ethics Committee (REC)</contact_name>
        <contact_address>25 Raza Saeed RD, bhabra Block M Gulberg 3, Lahore Lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
