<?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>IRCT20220115053712N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-28</date_registration>
      <primary_sponsor>Muhammad Institute of Medical and Allied Sciences, Multan</primary_sponsor>
      <public_title>Proprioceptive Exercises with and without Topical Glucosamine Sulfate in Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparative analysis of Proprioceptive Exercises with and without Topical Glucosamine Sulfate on Pain and Functional Disability in Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61682</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: participants will be assessed by physical assessment and by radiological findings (x-ray), Randomization description: Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes. Each participant will randomly choose the sealed envelope and open this sealed envelope, Blinding description: In a double-blinded study, participants and investigators will be blinded. Participants will be unaware of the type of treatments that will receive and the investigator will be unaware of the type of treatment on which group which intervention will be given and for what purpose that be evaluated after the completion of the intervention trial. subjects will choose between two samples. both the samples are in the same packing. In one sample, glucosamine sulfate gel with proprioceptive exercises i.e.,  standing on 1 leg [eyes open and closed], knee flexion and extension exercises [sitting position with a chair and TheraBand], Walking on heel and toes [forward, backward, left, right, carioca crossover with eyes open and closed], Half squat on soft ground, Side lunge, One-legged balance exercise. In another sample, an aqueous gel with no effects for the satisfaction of subjects and proprioceptive exercises i.e., Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises [sitting position with a chair and TheraBand], Walking on heel and toes [forward, backward, left, right, carioca crossover with eyes open and closed], Half squat on soft ground, Side lunge, One-legged balance exercise will be given. Subjects and investigators will be completely unaware of the type and effects of both interventions.</study_design>
      <phase>2</phase>
      <hc_freetext>Knee Osteoarthritis with grades 1, 2 and 3.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Group A will be treated with only proprioceptive exercises. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand ), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of treatment is 6 weeks. The frequency of treatment is 3 times per week exercise sessions lasted 30 minutes. Intervention 2: treatment group: Group-B will be treated with  proprioceptive exercises and glucosamine sulfate. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand ), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of  exercise is 6 weeks. The frequency of exercise is 3 times per week exercise sessions lasted 30 minutes. The glucosamine sulfate will apply topically twice daily, 3 times per week. the dosage of glucosamine sulfate gel will be 250mg two times a day. subjects will be instructed to clean the skin adjacent to their throbbing knee and apply the cream.</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:
Demographic data and data related to final outcome will
be shared by maintaining the confidentiality

When:
data will be available from Feb 2023 to March 2023 after the 6 months of publication.
The data sharing plan for a clinical trial (i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's International Clinical Trials Registry Platform; this occur before the first participant is enrolled.

To whom:
Hifza Arif(corresponding author)
Senior lecturer at Ali-Ul-Murtaza Department of Rehabilitation Sciences and Muhammad Institute of Medical and Allied Sciences Multan, Pakistan

Conditions:
For research purposes

Where to obtain:
To the corresponding author of the study; Dr. Hifza Arif
and can contact on
+923097697428
hifzaa630@gmail.com
can visit these search engines, you can find my study easily here
https://www.researchgate.net/
https://scholar.google.com/

How to obtain:
open-access and There is the traditional public data release where anyone can get access to the data with no registration or conditions.
The request will be reviewed by Director in Charge and in
case of eligibility, it would be shared in two weeks.

Comments:
I want randomized controlled trial registration.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Zahid Manzoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 309 7697428</telephone>
        <email>hifzaa630@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nimra Arif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 333 3877032</telephone>
        <email>angelnimra95@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 4-70 years
Cartilage degeneration
Local biomechanical factors (e.g., obesity, joint deformity, muscle weakness)
Nutritional factors
Postmenopausal women
Bilateral knee O.A with grade 1, 2 and 3
Both genders</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Knee replacement 
Rheumatoid arthritis
Steroidal injection in the past 2 months
Neuropathy
Tumor
Knee fractures
Neurological disorders (e.g., Alzheimer’s disease, Parkinson’s disease)
OA grade  4</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Group A will be treated with only proprioceptive exercises. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand ), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of treatment is 6 weeks. The frequency of treatment is 3 times per week exercise sessions lasted 30 minutes.</i_keyword>
      <i_keyword>treatment group: Group-B will be treated with  proprioceptive exercises and glucosamine sulfate. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand ), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of  exercise is 6 weeks. The frequency of exercise is 3 times per week exercise sessions lasted 30 minutes. The glucosamine sulfate will apply topically twice daily, 3 times per week. the dosage of glucosamine sulfate gel will be 250mg two times a day. subjects will be instructed to clean the skin adjacent to their throbbing knee and apply the cream.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before and after treatment (6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</prim_outcome>
      <prim_outcome>Functional activities. Timepoint: before and after treatment (6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stiffness. Timepoint: before and after treatment(6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</sec_outcome>
      <sec_outcome>Muscle tone strength. Timepoint: before and after treatment(6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</sec_outcome>
      <sec_outcome>Joint receptor function. Timepoint: before and after treatment(6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</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>Muhammad Institute of Medical and Allied Sciences, Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-18</approval_date>
        <contact_name>The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan</contact_name>
        <contact_address>HBL street, near Sabzazar metro station, Bosan road, Multan, Pakistan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
