<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04469309</url>
  </required_header>
  <id_info>
    <org_study_id>REC/00744 M Jaffar</org_study_id>
    <nct_id>NCT04469309</nct_id>
  </id_info>
  <brief_title>Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in BPPV.</brief_title>
  <official_title>Comparison of Half-Somersault Exercise With Brandt-Daroff Exercise in Patients With Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riphah International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riphah International University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is important as there are numbers of BPPV patients presenting to outpatient&#xD;
      departments which needs more efficient techniques for management of BPPV. Talking about&#xD;
      literature, there are numbers of studies done on different maneuvers but there is yet no&#xD;
      study available which compares these maneuvers. So the purpose of this study is to compare&#xD;
      these techniques to find which one is more effective in treating PC-BPPV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Benign paroxysmal positional vertigo (BPPV) is one of the most common causes in patients with&#xD;
      vestibular disorders .BPPV has often been described as &quot;self-limiting&quot; because symptoms often&#xD;
      subside or disappear within six months of onset . BPPV may be characterized by sudden changes&#xD;
      in the position of the head, such as lying down on one or both sides, looking right or left&#xD;
      side . Vertigo is defined as illusion of movement which could be spinning, rocking, tilting&#xD;
      or dropping . Benign paroxysmal positional vertigo (BPPV) is the most frequent vestibular&#xD;
      disorder and the leading cause of vertigo in adults.BPPV may be divided into 3 types based on&#xD;
      canal involvement i.e Posterior, Horizontal, and Anterior Semicircular Canal BPPV. BPPV&#xD;
      clinical findings agree with the hypothesis that semicircular canals with greater incidence&#xD;
      is posterior canal, have floating particles or debris, which are heavier than the circulating&#xD;
      endolymph . The vestibular system is located in the inner ear and consists of the utricle,&#xD;
      saccule and three semicircular canals (i.e. posterior, anterior and horizontal). These canals&#xD;
      react to rotational movements of the head . Of the types of BPPV, posterior semicircular&#xD;
      canal BPPV (PC-BPPV) is the most common form, accounting for 85 to 90% of cases Lateral Canal&#xD;
      BPPV is about 20%, and Anterior Canal BPPV is very rare as it is self-treated due to gravity&#xD;
      . BPPV accounts for 8% of the subjects with moderate or severe dizziness/vertigo. It may be&#xD;
      present in child hood but increases with age. The lifetime prevalence is estimated to be 2%.&#xD;
      It´s reported that the oneyear prevalence is 0.5% in 18-39 years old and 3.4% in people over&#xD;
      60-years of age . Benign paroxysmal positional vertigo (BPPV) is the paroxysmal transient&#xD;
      vertigo caused by specific changes in head position, accounting for 60% of peripheral&#xD;
      vertigo, with an incidence rate of approximately 64/10000 . The average recurrence rate is&#xD;
      around 50%. BPPV is more common in women than men; and the ratio of women to man population&#xD;
      is 2:1.BPPV can be caused either by canalithiasis or by cupulolithiasis. Movement of the head&#xD;
      causes these otoliths to inappropriately trigger the receptors in the semicircular canals and&#xD;
      send false signals to the brain, causing vertigo and nystagmus . Factors that can be helpful&#xD;
      in guiding the clinician in the evaluation of the patient with dizziness include the&#xD;
      characteristics of the dizziness; associated symptoms (ie, hearing loss or tinnitus) duration&#xD;
      of symptoms; and what, if anything, triggered the symptoms (precipitating factors) .&#xD;
      Posterior canal BPPV is treated using canalith repositioning procedures, the most common of&#xD;
      which is the Epley maneuver(EM) , half somersault exercises , Brandt Daroff exercise , Semont&#xD;
      maneuver, vestibular habituation exercises, balance and eye exercises . Dix-Hallpike test is&#xD;
      used to diagnose BPPV patients . Paramasivan Mani et al suggested in their study that half&#xD;
      somersault exercise with Brandt Daroff exercise for 3 weeks showed significantly greater&#xD;
      improvement in reducing self-perceived handicap among Patients with Posterior Canal Benign&#xD;
      Paroxysmal Positional Vertigo . Ashok Kumar Gupta et.al concluded that Epley maneuver has&#xD;
      produced maximum improvement than Semont maneuver and least improvement was produced by&#xD;
      Brandt-Daroff Exercises . Herman Guild Manayil John et al observed in their study that&#xD;
      Epley's manoeuvre to be a simple, useful and cost-effective treatment for BPPV . Nevzat&#xD;
      Demirbilek, conducted a study of Combined Epley and Semont Maneuver in Benign Paroxysmal&#xD;
      Positional Vertigo and concluded that, the combined maneuvers in our study were found to have&#xD;
      an increased success rate . Devangi S. Desai et al concluded that, both Epley's maneuver and&#xD;
      Brandt-daroff treatment approaches are effective in reducing symptoms and improving&#xD;
      independence level but combined approaches can give better results so modified&#xD;
      epley'smaneuver should be applied 3 times in one session along with brandt- daroff exercise&#xD;
      as home exercise .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vestibular activities and participation measure</measure>
    <time_frame>Change from Baseline dizziness and balance to 2 Weeks</time_frame>
    <description>The Vestibular Activities and Participation Measure (VAP) is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.The response range from none (0 points) ,moderate (2 points), severe (3 points) unable to do (4 points) to not applicable. The total score is obtained after calculating the average of the item scale values and excluding the not applicable item scale scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dix-Hall pike test</measure>
    <time_frame>Change from Baseline dizziness to 2 Week</time_frame>
    <description>Dix-Hall pike is the standard procedure for diagnosis of PC-BPPV. The Dix-Hallpike Test (DHT) is considered the gold standard assessment for the diagnosis of the vestibular disorder Benign Paroxysmal Positional Vertigo (BPPV). The Dix-Hallpike test involves rapidly moving the patient from a sitting position to &quot;head hanging,&quot; where the patient's head is at least 10 degrees below horizontal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fall efficacy scale (FES)</measure>
    <time_frame>Change from Baseline dizziness to 2 Week</time_frame>
    <description>Fall efficacy scale (FES) scale is a measure used to quantify an individual's concern of falling during different tasks. The FES is a reliable and valid tool for measuring an individual's concern of falling in a sample of people with vestibular disorders. It consists of 10 activities which are asked from patients.On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, A total score of greater than 70 indicates that the person has a fear of falling.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Vertigo, Paroxysmal</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I will receive Brandoff Exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II will receive Somersault exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group I Brandt-Daroff Exercises</intervention_name>
    <description>In group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too.&#xD;
The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment.</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group II Half-Somersault Maneuver</intervention_name>
    <description>In group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks.</description>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed Patients with PC-BPPV&#xD;
&#xD;
          -  Age group 25-50 years.&#xD;
&#xD;
          -  DHI Scale: 36-42 (moderate handicap)&#xD;
&#xD;
          -  Both gender&#xD;
&#xD;
          -  Duration of complaints: from the past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Migraine related dizziness and Anxiety disorder&#xD;
&#xD;
          -  Other vestibular conditions are: Acoustic neuroma, Labyrinthitis, Vestibular hypo&#xD;
             function, Meniere's disease.&#xD;
&#xD;
          -  Any cervical pathology,&#xD;
&#xD;
          -  CNS Pathology causing dizziness and vertigo&#xD;
&#xD;
          -  Other pathologies which may affect balance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Misbah Ghous, MSNMPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riphah International University Islamabad</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HMC Hospital Peshawar</name>
      <address>
        <city>Peshawar</city>
        <state>Khyber Pakhtunkha</state>
        <zip>25000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Gupta AK, Sharma KG, Sharma P. Effect of Epley, Semont Maneuvers and Brandt-Daroff Exercise on Quality of Life in Patients with Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (PSCBPPV). Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):99-103. doi: 10.1007/s12070-018-1322-7. Epub 2018 Mar 30.</citation>
    <PMID>30906723</PMID>
  </reference>
  <reference>
    <citation>Maranhao ET, Whitney SL, Maranhao-Filho P. Tumarkin-like phenomenon as a sign of therapeutic success in benign paroxysmal positional vertigo. Arq Neuropsiquiatr. 2018 Aug;76(8):534-538. doi: 10.1590/0004-282X20180073.</citation>
    <PMID>30231127</PMID>
  </reference>
  <reference>
    <citation>Beeumen N Van. Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie. 2018</citation>
  </reference>
  <reference>
    <citation>Zhang YX, Wu CL, Zhong FF, Ding CN. Evaluation of efficacies and recurrence rates of three self-treatment maneuvers for posterior semicircular canal benign paroxysmal positional vertigo. Int J Clin Exp Med. 2016;9(6):11780-7</citation>
  </reference>
  <reference>
    <citation>Kinne BL. Benign paroxysmal positional vertigo. Eye Mov Disord (Nystagmus Strabismus) Diagnosis, Manag Impact Qual Life. 2014;9(1):1-30.</citation>
  </reference>
  <reference>
    <citation>Desai DS, Chauhan AS, Trivedi MN. Role of Modified Epley'S Maneuver and Brandt-Daroff Exercises in Treatment of Posterior Canal Bppv: a Comparative Study. Int J Physiother Res. 2015;3(3):1059-64.</citation>
  </reference>
  <reference>
    <citation>Manayil John HG, John A. Efficacy of Epley'S Manoeuvre in Posterior Canal Benign Paroxysmal Positional Vertigo. J Evid Based Med Healthc. 2016;3(102):5624-7.</citation>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 6, 2021</last_update_submitted>
  <last_update_submitted_qc>March 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Half-Somersault Exercise</keyword>
  <keyword>Brandt-Daroff exercise</keyword>
  <keyword>Posterior Canal</keyword>
  <keyword>Benign Paroxysmal Positional Vertigo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Benign Paroxysmal Positional Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469309
org study id: REC/00744 M Jaffar
nct id: NCT04469309
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is important as there are numbers of BPPV patients presenting to outpatient
      departments which needs more efficient techniques for management of BPPV. Talking about
      literature, there are numbers of studies done on different maneuvers but there is yet no
      study available which compares these maneuvers. So the purpose of this study is to compare
      these techniques to find which one is more effective in treating PC-BPPV.
Benign paroxysmal positional vertigo (BPPV) is one of the most common causes in patients with
      vestibular disorders .BPPV has often been described as "self-limiting" because symptoms often
      subside or disappear within six months of onset . BPPV may be characterized by sudden changes
      in the position of the head, such as lying down on one or both sides, looking right or left
      side . Vertigo is defined as illusion of movement which could be spinning, rocking, tilting
      or dropping . Benign paroxysmal positional vertigo (BPPV) is the most frequent vestibular
      disorder and the leading cause of vertigo in adults.BPPV may be divided into 3 types based on
      canal involvement i.e Posterior, Horizontal, and Anterior Semicircular Canal BPPV. BPPV
      clinical findings agree with the hypothesis that semicircular canals with greater incidence
      is posterior canal, have floating particles or debris, which are heavier than the circulating
      endolymph . The vestibular system is located in the inner ear and consists of the utricle,
      saccule and three semicircular canals (i.e. posterior, anterior and horizontal). These canals
      react to rotational movements of the head . Of the types of BPPV, posterior semicircular
      canal BPPV (PC-BPPV) is the most common form, accounting for 85 to 90% of cases Lateral Canal
      BPPV is about 20%, and Anterior Canal BPPV is very rare as it is self-treated due to gravity
      . BPPV accounts for 8% of the subjects with moderate or severe dizziness/vertigo. It may be
      present in child hood but increases with age. The lifetime prevalence is estimated to be 2%.
      It´s reported that the oneyear prevalence is 0.5% in 18-39 years old and 3.4% in people over
      60-years of age . Benign paroxysmal positional vertigo (BPPV) is the paroxysmal transient
      vertigo caused by specific changes in head position, accounting for 60% of peripheral
      vertigo, with an incidence rate of approximately 64/10000 . The average recurrence rate is
      around 50%. BPPV is more common in women than men; and the ratio of women to man population
      is 2:1.BPPV can be caused either by canalithiasis or by cupulolithiasis. Movement of the head
      causes these otoliths to inappropriately trigger the receptors in the semicircular canals and
      send false signals to the brain, causing vertigo and nystagmus . Factors that can be helpful
      in guiding the clinician in the evaluation of the patient with dizziness include the
      characteristics of the dizziness; associated symptoms (ie, hearing loss or tinnitus) duration
      of symptoms; and what, if anything, triggered the symptoms (precipitating factors) .
      Posterior canal BPPV is treated using canalith repositioning procedures, the most common of
      which is the Epley maneuver(EM) , half somersault exercises , Brandt Daroff exercise , Semont
      maneuver, vestibular habituation exercises, balance and eye exercises . Dix-Hallpike test is
      used to diagnose BPPV patients . Paramasivan Mani et al suggested in their study that half
      somersault exercise with Brandt Daroff exercise for 3 weeks showed significantly greater
      improvement in reducing self-perceived handicap among Patients with Posterior Canal Benign
      Paroxysmal Positional Vertigo . Ashok Kumar Gupta et.al concluded that Epley maneuver has
      produced maximum improvement than Semont maneuver and least improvement was produced by
      Brandt-Daroff Exercises . Herman Guild Manayil John et al observed in their study that
      Epley's manoeuvre to be a simple, useful and cost-effective treatment for BPPV . Nevzat
      Demirbilek, conducted a study of Combined Epley and Semont Maneuver in Benign Paroxysmal
      Positional Vertigo and concluded that, the combined maneuvers in our study were found to have
      an increased success rate . Devangi S. Desai et al concluded that, both Epley's maneuver and
      Brandt-daroff treatment approaches are effective in reducing symptoms and improving
      independence level but combined approaches can give better results so modified
      epley'smaneuver should be applied 3 times in one session along with brandt- daroff exercise
      as home exercise .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Vestibular activities and participation measure
time frame: Change from Baseline dizziness and balance to 2 Weeks
description: The Vestibular Activities and Participation Measure (VAP) is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.The response range from none (0 points) ,moderate (2 points), severe (3 points) unable to do (4 points) to not applicable. The total score is obtained after calculating the average of the item scale values and excluding the not applicable item scale scores
measure: Dix-Hall pike test
time frame: Change from Baseline dizziness to 2 Week
description: Dix-Hall pike is the standard procedure for diagnosis of PC-BPPV. The Dix-Hallpike Test (DHT) is considered the gold standard assessment for the diagnosis of the vestibular disorder Benign Paroxysmal Positional Vertigo (BPPV). The Dix-Hallpike test involves rapidly moving the patient from a sitting position to "head hanging," where the patient's head is at least 10 degrees below horizontal.
measure: Fall efficacy scale (FES)
time frame: Change from Baseline dizziness to 2 Week
description: Fall efficacy scale (FES) scale is a measure used to quantify an individual's concern of falling during different tasks. The FES is a reliable and valid tool for measuring an individual's concern of falling in a sample of people with vestibular disorders. It consists of 10 activities which are asked from patients.On a scale from 1 to 10, with 1 being very confident and 10 being not confident at all, A total score of greater than 70 indicates that the person has a fear of falling.
arm group label: Group I
arm group type: Experimental
description: Group I will receive Brandoff Exercises
arm group label: Group II
arm group type: Active Comparator
description: Group II will receive Somersault exercises
intervention type: Other
intervention name: Group I Brandt-Daroff Exercises
description: In group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too.
The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment.
arm group label: Group I
intervention type: Other
intervention name: Group II Half-Somersault Maneuver
description: In group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks.
arm group label: Group II
criteria: 
gender: All
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: No
last name: Misbah Ghous, MSNMPT
role: Principal Investigator
affiliation: Riphah International University Islamabad
facility: 
country: Pakistan
citation: Gupta AK, Sharma KG, Sharma P. Effect of Epley, Semont Maneuvers and Brandt-Daroff Exercise on Quality of Life in Patients with Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (PSCBPPV). Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):99-103. doi: 10.1007/s12070-018-1322-7. Epub 2018 Mar 30.
PMID: 30906723
citation: Maranhao ET, Whitney SL, Maranhao-Filho P. Tumarkin-like phenomenon as a sign of therapeutic success in benign paroxysmal positional vertigo. Arq Neuropsiquiatr. 2018 Aug;76(8):534-538. doi: 10.1590/0004-282X20180073.
PMID: 30231127
citation: Beeumen N Van. Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie. 2018
citation: Zhang YX, Wu CL, Zhong FF, Ding CN. Evaluation of efficacies and recurrence rates of three self-treatment maneuvers for posterior semicircular canal benign paroxysmal positional vertigo. Int J Clin Exp Med. 2016;9(6):11780-7
citation: Kinne BL. Benign paroxysmal positional vertigo. Eye Mov Disord (Nystagmus Strabismus) Diagnosis, Manag Impact Qual Life. 2014;9(1):1-30.
citation: Desai DS, Chauhan AS, Trivedi MN. Role of Modified Epley'S Maneuver and Brandt-Daroff Exercises in Treatment of Posterior Canal Bppv: a Comparative Study. Int J Physiother Res. 2015;3(3):1059-64.
citation: Manayil John HG, John A. Efficacy of Epley'S Manoeuvre in Posterior Canal Benign Paroxysmal Positional Vertigo. J Evid Based Med Healthc. 2016;3(102):5624-7.
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Benign Paroxysmal Positional Vertigo
mesh term: Dizziness
sharing ipd: No