<?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>IRCT20240315061294N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-31</date_registration>
      <primary_sponsor>the university of Faisalabad</primary_sponsor>
      <public_title>Effects of Semont Liberatory Maneuver Versus Cawthorne Cooksey Exercise in posterior canal benign paroxysmal positional vertigo (BPPV)</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of Semont Liberatory Maneuver Versus Cawthorne Cooksey Exercise in posterior canal benign paroxysmal positional vertigo (BPPV)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76073</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: method of randomization is simple random sampling.
1- population was selected i.e. females of age 25-45
2- sample size of 28 was taken
3- two groups were made
4-each group was assigned to have 14 patients 
5- We used "Drawing Lots" as a method to select and allocate population into groups.
6- we gave group A semont liberatory maneuver
7-and group B the Cawthorne cooksey exercises
8- then collected data for 3 weeks from both the groups
9- we then analyzed the data using SPSS, Blinding description: The primary aim of a single-blinded study is to reduce or eliminate the placebo effect and other forms of bias that might affect the participants' behavior or self-reported outcomes. By blinding the participants, researchers can obtain more accurate and objective data regarding the efficacy and safety of the intervention being tested.
Develop a Protocol: Created a detailed study plan, including the hypothesis, inclusion/exclusion criteria, intervention details, and outcome measures.
Recruit Participants: Selected a sample that meets the study criteria.
Randomize Participants: Randomly assigned participants to be in any of the group.
Implement Blinding: Ensured participants do not know which group they are in. This may involve using identical-looking placebos for the control group.
Administer the Intervention: Provide the treatment or placebo to the respective groups according to the study protocol.
Collect Data: Gathered data on the outcomes of interest while maintaining blinding.
Analyze Results: Compared the outcomes between the treatment and control groups using appropriate statistical methods.
Report Findings: Present the results, discussing the implications, limitations, and potential biases.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign paroxysmal positional vertigo (BPPV) is one of the most common causes of vertigo — the sudden sensation that you're spinning or that the inside of your head is spinning. BPPV causes brief episodes of mild to intense dizziness. It is usually triggered by specific changes in your head's position..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: receives semont liberatory maneuver The Semont Liberatory Maneuver is a physical therapy technique used to treat Benign Paroxysmal Positional Vertigo (BPPV), particularly when it affects the posterior semicircular canal of the inner ear. Here is a summary of how to perform the maneuver The Semont Maneuver aims to move the dislodged otoliths (calcium carbonate crystals) in the inner ear back to their correct position, alleviating the vertigo symptoms associated with BPPV.Starting Position: The patient sits on an examination table with their legs hanging off the side and head turned 45 degrees toward the unaffected side.First Movement: Quickly move the patient to a lying position on their affected side (the side experiencing vertigo), with the head still turned 45 degrees. The patient’s head should now be facing upward.Maintain this position for about 30 seconds or until the vertigo stops. Second Movement: Without changing the head position, rapidly move the patient to the opposite side. The patient’s head will now be turned 45 degrees downward, lying on the unaffected side.Hold this position for about 30 seconds or until the vertigo subsides.Returning to Sitting Position:Slowly bring the patient back to a sitting position, keeping the head turned toward the unaffected side. Intervention 2: Intervention group 2: receives cawthorne cooksey exercise The primary goal of Cawthorne-Cooksey exercises is to facilitate vestibular compensation, which involves retraining the brain to adapt to changes in balance and spatial orientation signals caused by inner ear problems.The exercises are typically performed in progressive stages, starting with simple movements and gradually advancing to more complex tasks. Here’s a summary of the typical exercises included:Early Stage Exercises (Performed while sitting or lying down)Eye Movements:Look up and down, then left and right, keeping the head still. Gradually increase speed.Head Movements:Turn the head from side to side, then up and down, initially with eyes open and then with eyes closed.Shrugging and Circling Shoulders:Perform shoulder shrugging and shoulder circling exercises to enhance coordination and reduce neck tension.Intermediate Stage Exercises (Performed while sitting)Sitting and Standing Movements:Sit down and stand up repeatedly, first with eyes open and then with eyes closed.Throwing and Catching:Throw a small ball from hand to hand above eye level.Advanced Stage Exercises (Performed while standing and walking)Standing Balance:Stand with feet together, then progress to standing on one foot. Repeat with eyes open and then closed.Walking Exercises:Walk across the room with eyes open, then closed.Walk up and down a slope or stairs.Walk in a circle or figure-eight pattern.</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 semont liberatory maneuver and cawthorne cooksey exercises in posterior canal bppv

When:
starting 6 months after publication . and it will remain available for everyone

To whom:
this will be available for everyone

Conditions:
drruhmatariq@gmail.com
contact # 03236617619

Where to obtain:
ruhma19@yahoo.com
contact #: 03236617619

How to obtain:
for any problem contact for data/file at ruhma19@gmail.com or contact at 03236617619

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ruhma Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P 881 shadab colony jhang road faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 323 6617619</telephone>
        <email>ruhma19@yahoo.com</email>
        <affiliation>Physthetic Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ruhma Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>p 881 street #6 shadab colony jhang road Faisalabad</address>
        <city>faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 323 6617619</telephone>
        <email>ruhma19@yahoo.com</email>
        <affiliation>Physthetic Clinic Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender female
Willing participants
Age 25-45 years
Acute cases of BPPV
Participants physically capable of undergoing the Semont maneuver
Positive Dix-Hallpike test
Absence of other vestibular disorders</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients with progressive vascular  pathology
Patients with active vertigo complaints
Patients having neck fragility or neck instability
Patients who had some brainstem or cerebellar signs
Mentally unstable   patients
Patients  with cognitive and perceptual problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign paroxysmal vertigo</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: receives semont liberatory maneuver The Semont Liberatory Maneuver is a physical therapy technique used to treat Benign Paroxysmal Positional Vertigo (BPPV), particularly when it affects the posterior semicircular canal of the inner ear. Here is a summary of how to perform the maneuver The Semont Maneuver aims to move the dislodged otoliths (calcium carbonate crystals) in the inner ear back to their correct position, alleviating the vertigo symptoms associated with BPPV.Starting Position: The patient sits on an examination table with their legs hanging off the side and head turned 45 degrees toward the unaffected side.First Movement: Quickly move the patient to a lying position on their affected side (the side experiencing vertigo), with the head still turned 45 degrees. The patient’s head should now be facing upward.Maintain this position for about 30 seconds or until the vertigo stops. Second Movement: Without changing the head position, rapidly move the patient to the opposite side. The patient’s head will now be turned 45 degrees downward, lying on the unaffected side.Hold this position for about 30 seconds or until the vertigo subsides.Returning to Sitting Position:Slowly bring the patient back to a sitting position, keeping the head turned toward the unaffected side.</i_keyword>
      <i_keyword>Intervention group 2: receives cawthorne cooksey exercise The primary goal of Cawthorne-Cooksey exercises is to facilitate vestibular compensation, which involves retraining the brain to adapt to changes in balance and spatial orientation signals caused by inner ear problems.The exercises are typically performed in progressive stages, starting with simple movements and gradually advancing to more complex tasks. Here’s a summary of the typical exercises included:Early Stage Exercises (Performed while sitting or lying down)Eye Movements:Look up and down, then left and right, keeping the head still. Gradually increase speed.Head Movements:Turn the head from side to side, then up and down, initially with eyes open and then with eyes closed.Shrugging and Circling Shoulders:Perform shoulder shrugging and shoulder circling exercises to enhance coordination and reduce neck tension.Intermediate Stage Exercises (Performed while sitting)Sitting and Standing Movements:Sit down and stand up repeatedly, first with eyes open and then with eyes closed.Throwing and Catching:Throw a small ball from hand to hand above eye level.Advanced Stage Exercises (Performed while standing and walking)Standing Balance:Stand with feet together, then progress to standing on one foot. Repeat with eyes open and then closed.Walking Exercises:Walk across the room with eyes open, then closed.Walk up and down a slope or stairs.Walk in a circle or figure-eight pattern.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>This study will help to improve the different aspects of patients' problems with posterior canal benign paroxysmal positional vertigo (BPPV) as this is one of the most common problems now a days. It will improve the understanding of clinicians about two major techniques of treating BPPV. It will improve the quality of life of patients and their attendants. Timepoint: Before intervension and 1,2,3 weeks after intervention. Method of measurement: VAS for vertigo and Dizziness questionnaire.</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>the university of faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-05</approval_date>
        <contact_name>Research and Ethics Committee of the University of Faisalabad</contact_name>
        <contact_address>university avenue faisal town canal road faisalabad Faisalabad punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
