<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/NCT04413084</url>
  </required_header>
  <id_info>
    <org_study_id>REC/00653 Poshmal butt</org_study_id>
    <nct_id>NCT04413084</nct_id>
  </id_info>
  <brief_title>Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.</brief_title>
  <official_title>Effects of Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.</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>
      There is a need to manage dizziness in vestibular dysfunction patients with the vestibular&#xD;
      rehabilitation to improve the life style of these patients. Vestibular rehabilitation&#xD;
      exercises are beneficial for the vestibular dysfunction patients because they decrease&#xD;
      dizziness and visual symptoms, increase walking and balance functions and with this the&#xD;
      general activity level also increases. In my study my goal is to apply two different&#xD;
      vestibular exercise and check their effects on dizziness in hearing impaired children's.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dizziness is not a disease it is one of the most common symptoms of vestibular dysfunction.&#xD;
      There are mainly two types of vestibular dysfunction central and peripheral vestibular&#xD;
      dysfunction. Signs of vestibular dysfunction are vertigo, nystagmus, visual instability on&#xD;
      head movement, spinning, double vision, May or may not have hearing loss or tinnitus. Due to&#xD;
      these problem the patient feel difficulty in movements and in other activities, asymmetrical&#xD;
      posture in sitting or standing. patients who experience dizziness report a significant&#xD;
      disability that reduces their quality of life.&#xD;
&#xD;
      Vestibular system is consist of two parts central vestibular system and peripheral vestibular&#xD;
      system. Peripheral part is consist of three semi-circular canals and otolith organs. The&#xD;
      three semi-circular canals horizontal, posterior and anterior respond to angular acceleration&#xD;
      and are right angle to one another. Semi-circular canals are filled with endolymph. Which&#xD;
      move freely within each canal in response to the direction of the angular head rotation. The&#xD;
      saccule and utricle make up the otolith organ which respond to the linear acceleration and&#xD;
      the static head tilt. Three main functions of the peripheral vestibular system is stabilize&#xD;
      visual images during head movement, maintain postural stability during head movement and&#xD;
      providing information about the environment. In the central vestibular system brainstem&#xD;
      processes provide primary control of many vestibular reflex. Connection with the thalamus,&#xD;
      vestibular cortex and reticular system enable the vestibular system to aware of arousal and&#xD;
      conscious awareness of the body and discrimination between the self and environment.&#xD;
&#xD;
      In children, vestibular function plays an important role in postural and gross motor&#xD;
      development control. Children with congenitally profound hearing loss suffer vestibular&#xD;
      dysfunction in both ears, and loss of postural control. Maintaining and development of&#xD;
      postural stability is a multisystem process it does not only depend on vestibular input.&#xD;
      Maturational changes in proprioceptive and visual, central nervous system processing, and&#xD;
      coordination of motor output are responsible for the changes in postural skills observed&#xD;
      through adolescence. Infants and young children are dependent on the visual system to&#xD;
      maintain balance. As they grow older, begin to use somatosensory and vestibular information&#xD;
      properly. Between the 3 sensory inputs in children, the vestibular system seems to be the&#xD;
      slightest effective in postural control.&#xD;
&#xD;
      Children with early sensorineural hearing loss and bilateral vestibular dysfunction present&#xD;
      with delayed gross motor development. These children stand and walk later than their peers.&#xD;
      Difficulties in maintaining balance can lead to challenges in normal childhood activities&#xD;
      e.g. riding a bicycle or hopping. Reduced ability to participate in normal play with other&#xD;
      children may result in social isolation. In hearing impaired children vestibular dysfunction&#xD;
      is common. It was mentioned in a study held in 2013 that 88% of hearing impaired children&#xD;
      suffer from vestibular dysfunction. This could mainly be due to hearing and vestibular&#xD;
      impulses pass via the vestibule-cochlear nerve. Another study in 2018, found that vestibular&#xD;
      dysfunction to be around 50% in hearing impaired children.&#xD;
&#xD;
      Gaze stability and Brandt-Daroff exercises are two different type of exercises which are used&#xD;
      for rehabilitation of dizziness in hearing impaired patients. A type of habituation exercise&#xD;
      is Brandt- Daroff exercises which are easy to perform. Brandt- Daroff exercises cause the&#xD;
      debris to get dislodged from the cupula of the posterior semi-circular canal and will no&#xD;
      longer effect cupula during the head movements. Bandt-Daroff exercises are performed with&#xD;
      quick head rotations while watching a visual target and sustaining focus on the visual target&#xD;
      during head movements. Gaze stability exercises designed to improve the gaze stability. These&#xD;
      exercises require the individual to fixate on a visual target during horizontal or vertical&#xD;
      head movement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">October 15, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 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>Dix Hall Pike Test</measure>
    <time_frame>Change from Baseline dizziness and balance to 2 Weeks</time_frame>
    <description>The Dix hall pike test is a diagnostic procedure. When performing the test, patients are lowered quickly to supine position with 30 degrees neck extension below horizontal by the clinician. Positive test is reported when the patients report of a production of vertigo and observation of nystagmus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fukuda Step Test</measure>
    <time_frame>Change from Baseline dizziness to 2 Week</time_frame>
    <description>A vestibulospinal test, fukuda test is used to measure asymmetrical labyrinthine function. One's ability to step in place with eyes closed without turning depends on normal vestibulospinal and proprioceptive function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motion Sensitivity Quotient</measure>
    <time_frame>Change from Baseline dizziness to 2 Week</time_frame>
    <description>Motion Sensitivity Quotient: is a clinical protocol designed to measure motion provoked dizziness during a series of quick changes to head or body position. Test is used as a guide for exercise developing for the patients problems with the motion provoked dizziness, also for the effectiveness of rehabilitation therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dizziness Handicap Inventory</measure>
    <time_frame>Change from Baseline dizziness to 2 Week</time_frame>
    <description>Dizziness Handicap Inventory: is a self-assessment inventory designed to evaluate the effect of dizziness and unsteadiness. Graded on a scale of 0-100, higher score shows greater perception of handicap due to dizziness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sharpened Romberg's Test</measure>
    <time_frame>Change from Baseline balance to 2 Week</time_frame>
    <description>: is an appropriate tool to diagnose gait disturbance caused by abnormal proprioception involving information about the joints. Patients is ask to stand quietly with eyes closed. Patients tries to maintain his balance. The score is counted by the time the patients is able to stand with the eyes closed. A positive sign is noted when a sway is noted with the closed eyes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>HEARING IMPAIRED CHILDREN</condition>
  <arm_group>
    <arm_group_label>Gaze stability exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group I will receive Gaze stability exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brandt-Daroff Exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group II will receive Brandt-Daroff Exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gaze stability exercises</intervention_name>
    <description>Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.</description>
    <arm_group_label>Gaze stability exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brandt-Daroff Exercises</intervention_name>
    <description>Brandt-Daroff Exercises&#xD;
Start sitting upright on the edge of the bed.&#xD;
Turn your head 45 degrees to the left, or as far as is comfortable.&#xD;
Lie down on your right side.&#xD;
Remain in this position for 30 seconds or until any dizziness has subsided.&#xD;
Sit up and turn head back to center.&#xD;
Turn your head 45 degrees to the right, or as far as is comfortable.&#xD;
Lie down on your left side.&#xD;
Remain in this position for 30 seconds or until any dizziness has subsided.&#xD;
Sit up and turn head back to center.</description>
    <arm_group_label>Brandt-Daroff Exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with hearing impairment of both genders, those diagnosed with vestibular&#xD;
             dysfunction by ear nose and throat specialist.&#xD;
&#xD;
          -  Bilateral hearing loss&#xD;
&#xD;
          -  Mild to moderate hearing loss&#xD;
&#xD;
          -  Age between 8 to 17 years.&#xD;
&#xD;
          -  Any test of the following four tests positive (Dix Hall Pike test, Supine Roll's test,&#xD;
             Fukuda Stepping Test and Sharpened Romberg's test) were included in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children receiving some other form of treatment for vestibular dysfunction.&#xD;
&#xD;
          -  Suffering from other systemic disorders.&#xD;
&#xD;
          -  Musculoskeletal disorders like fractures, strains, sprains leading to imbalance,&#xD;
             central or peripheral neurologic diseases leading to disturbed balance.&#xD;
&#xD;
          -  Those who were handicapped were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 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>. National Special Education Center Muzaffarabad department of social welfare &amp; women development.</name>
      <address>
        <city>Muzaffarabad</city>
        <state>Azad Kashmir</state>
        <zip>13100</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Khandare S, Gonsalves N, Palekar DT, Rathi DM, Desai R, Deshmukh MJIJoCRiLS. Efficacy of two different vestibular rehabilitation approaches for dizziness in vestibular dysfunction in hearing impaired children&quot;. 2018;7(05):1985-8.</citation>
  </reference>
  <reference>
    <citation>Hsiao CJ, Cherry DK, Beatty PC, Rechtsteiner EA. National Ambulatory Medical Care Survey: 2007 summary. Natl Health Stat Report. 2010 Nov 3;(27):1-32.</citation>
    <PMID>21089986</PMID>
  </reference>
  <reference>
    <citation>Lakhani H, Saxena PP, Shethia UJp. Effectiveness of Brandt-daroff exercises on hearing impaired children: A Comparative Study.2:100.</citation>
  </reference>
  <reference>
    <citation>Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.</citation>
    <PMID>20588090</PMID>
  </reference>
  <reference>
    <citation>Suarez H, Angeli S, Suarez A, Rosales B, Carrera X, Alonso R. Balance sensory organization in children with profound hearing loss and cochlear implants. Int J Pediatr Otorhinolaryngol. 2007 Apr;71(4):629-37. doi: 10.1016/j.ijporl.2006.12.014. Epub 2007 Feb 2.</citation>
    <PMID>17275927</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 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>Dizziness</keyword>
  <keyword>Hearing Impaired children</keyword>
  <keyword>Vestibular rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss</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/NCT04413084
org study id: REC/00653 Poshmal butt
nct id: NCT04413084
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a need to manage dizziness in vestibular dysfunction patients with the vestibular
      rehabilitation to improve the life style of these patients. Vestibular rehabilitation
      exercises are beneficial for the vestibular dysfunction patients because they decrease
      dizziness and visual symptoms, increase walking and balance functions and with this the
      general activity level also increases. In my study my goal is to apply two different
      vestibular exercise and check their effects on dizziness in hearing impaired children's.
Dizziness is not a disease it is one of the most common symptoms of vestibular dysfunction.
      There are mainly two types of vestibular dysfunction central and peripheral vestibular
      dysfunction. Signs of vestibular dysfunction are vertigo, nystagmus, visual instability on
      head movement, spinning, double vision, May or may not have hearing loss or tinnitus. Due to
      these problem the patient feel difficulty in movements and in other activities, asymmetrical
      posture in sitting or standing. patients who experience dizziness report a significant
      disability that reduces their quality of life.

      Vestibular system is consist of two parts central vestibular system and peripheral vestibular
      system. Peripheral part is consist of three semi-circular canals and otolith organs. The
      three semi-circular canals horizontal, posterior and anterior respond to angular acceleration
      and are right angle to one another. Semi-circular canals are filled with endolymph. Which
      move freely within each canal in response to the direction of the angular head rotation. The
      saccule and utricle make up the otolith organ which respond to the linear acceleration and
      the static head tilt. Three main functions of the peripheral vestibular system is stabilize
      visual images during head movement, maintain postural stability during head movement and
      providing information about the environment. In the central vestibular system brainstem
      processes provide primary control of many vestibular reflex. Connection with the thalamus,
      vestibular cortex and reticular system enable the vestibular system to aware of arousal and
      conscious awareness of the body and discrimination between the self and environment.

      In children, vestibular function plays an important role in postural and gross motor
      development control. Children with congenitally profound hearing loss suffer vestibular
      dysfunction in both ears, and loss of postural control. Maintaining and development of
      postural stability is a multisystem process it does not only depend on vestibular input.
      Maturational changes in proprioceptive and visual, central nervous system processing, and
      coordination of motor output are responsible for the changes in postural skills observed
      through adolescence. Infants and young children are dependent on the visual system to
      maintain balance. As they grow older, begin to use somatosensory and vestibular information
      properly. Between the 3 sensory inputs in children, the vestibular system seems to be the
      slightest effective in postural control.

      Children with early sensorineural hearing loss and bilateral vestibular dysfunction present
      with delayed gross motor development. These children stand and walk later than their peers.
      Difficulties in maintaining balance can lead to challenges in normal childhood activities
      e.g. riding a bicycle or hopping. Reduced ability to participate in normal play with other
      children may result in social isolation. In hearing impaired children vestibular dysfunction
      is common. It was mentioned in a study held in 2013 that 88% of hearing impaired children
      suffer from vestibular dysfunction. This could mainly be due to hearing and vestibular
      impulses pass via the vestibule-cochlear nerve. Another study in 2018, found that vestibular
      dysfunction to be around 50% in hearing impaired children.

      Gaze stability and Brandt-Daroff exercises are two different type of exercises which are used
      for rehabilitation of dizziness in hearing impaired patients. A type of habituation exercise
      is Brandt- Daroff exercises which are easy to perform. Brandt- Daroff exercises cause the
      debris to get dislodged from the cupula of the posterior semi-circular canal and will no
      longer effect cupula during the head movements. Bandt-Daroff exercises are performed with
      quick head rotations while watching a visual target and sustaining focus on the visual target
      during head movements. Gaze stability exercises designed to improve the gaze stability. These
      exercises require the individual to fixate on a visual target during horizontal or vertical
      head movement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Dix Hall Pike Test
time frame: Change from Baseline dizziness and balance to 2 Weeks
description: The Dix hall pike test is a diagnostic procedure. When performing the test, patients are lowered quickly to supine position with 30 degrees neck extension below horizontal by the clinician. Positive test is reported when the patients report of a production of vertigo and observation of nystagmus.
measure: Fukuda Step Test
time frame: Change from Baseline dizziness to 2 Week
description: A vestibulospinal test, fukuda test is used to measure asymmetrical labyrinthine function. One's ability to step in place with eyes closed without turning depends on normal vestibulospinal and proprioceptive function.
measure: Motion Sensitivity Quotient
time frame: Change from Baseline dizziness to 2 Week
description: Motion Sensitivity Quotient: is a clinical protocol designed to measure motion provoked dizziness during a series of quick changes to head or body position. Test is used as a guide for exercise developing for the patients problems with the motion provoked dizziness, also for the effectiveness of rehabilitation therapy
measure: Dizziness Handicap Inventory
time frame: Change from Baseline dizziness to 2 Week
description: Dizziness Handicap Inventory: is a self-assessment inventory designed to evaluate the effect of dizziness and unsteadiness. Graded on a scale of 0-100, higher score shows greater perception of handicap due to dizziness
measure: Sharpened Romberg's Test
time frame: Change from Baseline balance to 2 Week
description: : is an appropriate tool to diagnose gait disturbance caused by abnormal proprioception involving information about the joints. Patients is ask to stand quietly with eyes closed. Patients tries to maintain his balance. The score is counted by the time the patients is able to stand with the eyes closed. A positive sign is noted when a sway is noted with the closed eyes.
arm group label: Gaze stability exercises
arm group type: Experimental
description: Group I will receive Gaze stability exercises.
arm group label: Brandt-Daroff Exercises
arm group type: Experimental
description: Group II will receive Brandt-Daroff Exercises.
intervention type: Other
intervention name: Gaze stability exercises
description: Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.
arm group label: Gaze stability exercises
intervention type: Other
intervention name: Brandt-Daroff Exercises
description: Brandt-Daroff Exercises
Start sitting upright on the edge of the bed.
Turn your head 45 degrees to the left, or as far as is comfortable.
Lie down on your right side.
Remain in this position for 30 seconds or until any dizziness has subsided.
Sit up and turn head back to center.
Turn your head 45 degrees to the right, or as far as is comfortable.
Lie down on your left side.
Remain in this position for 30 seconds or until any dizziness has subsided.
Sit up and turn head back to center.
arm group label: Brandt-Daroff Exercises
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Misbah Ghous, MSNMPT
role: Principal Investigator
affiliation: Riphah International University Islamabad
facility: 
country: Pakistan
citation: Khandare S, Gonsalves N, Palekar DT, Rathi DM, Desai R, Deshmukh MJIJoCRiLS. Efficacy of two different vestibular rehabilitation approaches for dizziness in vestibular dysfunction in hearing impaired children". 2018;7(05):1985-8.
citation: Hsiao CJ, Cherry DK, Beatty PC, Rechtsteiner EA. National Ambulatory Medical Care Survey: 2007 summary. Natl Health Stat Report. 2010 Nov 3;(27):1-32.
PMID: 21089986
citation: Lakhani H, Saxena PP, Shethia UJp. Effectiveness of Brandt-daroff exercises on hearing impaired children: A Comparative Study.2:100.
citation: Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
PMID: 20588090
citation: Suarez H, Angeli S, Suarez A, Rosales B, Carrera X, Alonso R. Balance sensory organization in children with profound hearing loss and cochlear implants. Int J Pediatr Otorhinolaryngol. 2007 Apr;71(4):629-37. doi: 10.1016/j.ijporl.2006.12.014. Epub 2007 Feb 2.
PMID: 17275927
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Deafness
mesh term: Hearing Loss
mesh term: Dizziness
sharing ipd: No