<?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>IRCT20190715044216N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-10</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>comparison of concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>comparison of concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61186</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group according to consort guideline 2010. Written informed consent will be taken.  After enrollment into study, patient will be allocated either to Group 1 and Group 2 by lottery method. No. of Chits will be equal to total sample size. Each patients will be requested to draw a chit from the box and after that patient will be recruited into either Group 1 and Group 2, Blinding description: 1. It will be a single blinded study
2. Participants of both groups will be kept unfamiliar to the treatment protocol by lottery method. 
3. Participants of both groups will be called for treatment on alternate days in a week.
4. The health care provider (physical therapist) will be aware to the whole treatment procedure that will be provided to the participants.</study_design>
      <phase>3</phase>
      <hc_freetext>Posterior Tibial Tendon Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:will perform posterior tibialis exercise with ankle in planter flexion and eversion  in supine lying position +heating packs for 20 minutes and A Thera-band will be place under the Ankle and advice the patient to extend their ankle by pushing the downward of ankle into thera-band while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of planter flexion perform once at the hospital and once at home for the 2 days/6-week time for testing up:. Intervention 2: Intervention group 2:will perform posterior tibialis exercise with ankle in dorsiflexion and inversion  in supine lying position + heating packs for 20 minutes and A Thera-band will be place above the Ankle and advice the patient to flex their ankle by pushing the upward of ankle into thera-band while keep your ankle in dorsiflexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of planter flexion perform once at the hospital and once at home for the 2 days/6-week time for testing up:.</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:
comparison of concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction

When:
30-6-2022

To whom:
people working in academic situation

Conditions:
Author will review the request

Where to obtain:
drabduljabbar743725@gmail.com

How to obtain:
request will be entertained through email after which people working in academic institutions will be granted request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Jabbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house # 9, street # 21, Mohala Neewa chah mira lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 348 4266429</telephone>
        <email>drabduljabbar743725@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Jabbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house # 9, street # 21, Mohala Neewa chah mira lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 348 4266429</telephone>
        <email>drabduljabbar743725@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 40–60 years •
Current complaint of foot and ankle pain that has lasted for three months or more
Flexible pes planovalgus deformity in the clinical assessment
Pes planovalgus foot deformity with longitudinal arch flattening verified by radiograph</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Rigid foot deformity
Acute infection or alcohol addiction limiting participation in study protocol Acute use of local or systemic analgesics
Acute overuse or traumatic injury to the lower leg (excluding pes planovalgus associated pathology)
Prior surgery to the lower limb</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Posterior tibial tendinitis</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 1:will perform posterior tibialis exercise with ankle in planter flexion and eversion  in supine lying position +heating packs for 20 minutes and A Thera-band will be place under the Ankle and advice the patient to extend their ankle by pushing the downward of ankle into thera-band while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of planter flexion perform once at the hospital and once at home for the 2 days/6-week time for testing up:</i_keyword>
      <i_keyword>Intervention group 2:will perform posterior tibialis exercise with ankle in dorsiflexion and inversion  in supine lying position + heating packs for 20 minutes and A Thera-band will be place above the Ankle and advice the patient to flex their ankle by pushing the upward of ankle into thera-band while keep your ankle in dorsiflexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of planter flexion perform once at the hospital and once at home for the 2 days/6-week time for testing up:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Intervention treatment will be given to subjects 2 sessions per week and 2 sets per day, 1 set in clinical setup and 2nd for home plan. Total intervention period will be of 6 weeks. Method of measurement: Pain Disability Index (PDI).</prim_outcome>
      <prim_outcome>Disability. Timepoint: Intervention treatment will be given to subjects 2 sessions per week and 2 sets per day, 1 set in clinical setup and 2nd for home plan. Total intervention period will be of 6 weeks. Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-07</approval_date>
        <contact_name>Riphah international research and ethics committe</contact_name>
        <contact_address>28M Quid e azam industrial estate kot lakhpat lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
