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Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.

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ClinicalTrials.gov Identifier: NCT04413084
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HEARING IMPAIRED CHILDREN Other: Gaze stability exercises Other: Brandt-Daroff Exercises Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
Actual Study Start Date : August 1, 2020
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 15, 2020


Arm Intervention/treatment
Experimental: Gaze stability exercises
Group I will receive Gaze stability exercises.
Other: Gaze stability exercises
Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.

Experimental: Brandt-Daroff Exercises
Group II will receive Brandt-Daroff Exercises.
Other: Brandt-Daroff Exercises

Brandt-Daroff Exercises

  1. Start sitting upright on the edge of the bed.
  2. Turn your head 45 degrees to the left, or as far as is comfortable.
  3. Lie down on your right side.
  4. Remain in this position for 30 seconds or until any dizziness has subsided.
  5. Sit up and turn head back to center.
  6. Turn your head 45 degrees to the right, or as far as is comfortable.
  7. Lie down on your left side.
  8. Remain in this position for 30 seconds or until any dizziness has subsided.
  9. Sit up and turn head back to center.




Primary Outcome Measures :
  1. Dix Hall Pike Test [ Time Frame: Change from Baseline dizziness and balance to 2 Weeks ]
    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.

  2. Fukuda Step Test [ Time Frame: Change from Baseline dizziness to 2 Week ]
    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.

  3. Motion Sensitivity Quotient [ Time Frame: Change from Baseline dizziness to 2 Week ]
    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


Secondary Outcome Measures :
  1. Dizziness Handicap Inventory [ Time Frame: Change from Baseline dizziness to 2 Week ]
    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

  2. Sharpened Romberg's Test [ Time Frame: Change from Baseline balance to 2 Week ]
    : 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.



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with hearing impairment of both genders, those diagnosed with vestibular dysfunction by ear nose and throat specialist.
  • Bilateral hearing loss
  • Mild to moderate hearing loss
  • Age between 8 to 17 years.
  • Any test of the following four tests positive (Dix Hall Pike test, Supine Roll's test, Fukuda Stepping Test and Sharpened Romberg's test) were included in the study

Exclusion Criteria:

  • Children receiving some other form of treatment for vestibular dysfunction.
  • Suffering from other systemic disorders.
  • Musculoskeletal disorders like fractures, strains, sprains leading to imbalance, central or peripheral neurologic diseases leading to disturbed balance.
  • Those who were handicapped were excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413084


Locations
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Pakistan
. National Special Education Center Muzaffarabad department of social welfare & women development.
Muzaffarabad, Azad Kashmir, Pakistan, 13100
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Misbah Ghous, MSNMPT Riphah International University Islamabad
Publications:
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04413084    
Other Study ID Numbers: REC/00653 Poshmal butt
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Dizziness
Hearing Impaired children
Vestibular rehabilitation
Additional relevant MeSH terms:
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Vertigo
Deafness
Hearing Loss
Dizziness
Sensation Disorders
Neurologic Manifestations
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Nervous System Diseases
Hearing Disorders