Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
Primary Purpose
HEARING IMPAIRED CHILDREN
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gaze stability exercises
Brandt-Daroff Exercises
Sponsored by
About this trial
This is an interventional treatment trial for HEARING IMPAIRED CHILDREN focused on measuring Dizziness, Hearing Impaired children, Vestibular rehabilitation
Eligibility 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.
Sites / Locations
- . National Special Education Center Muzaffarabad department of social welfare & women development.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gaze stability exercises
Brandt-Daroff Exercises
Arm Description
Group I will receive Gaze stability exercises.
Group II will receive Brandt-Daroff Exercises.
Outcomes
Primary Outcome Measures
Dix Hall Pike Test
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.
Fukuda Step Test
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.
Motion Sensitivity Quotient
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
Dizziness Handicap Inventory
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
Sharpened Romberg's Test
: 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.
Full Information
NCT ID
NCT04413084
First Posted
April 14, 2020
Last Updated
March 6, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04413084
Brief Title
Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
Official Title
Effects of Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HEARING IMPAIRED CHILDREN
Keywords
Dizziness, Hearing Impaired children, Vestibular rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gaze stability exercises
Arm Type
Experimental
Arm Description
Group I will receive Gaze stability exercises.
Arm Title
Brandt-Daroff Exercises
Arm Type
Experimental
Arm Description
Group II will receive Brandt-Daroff Exercises.
Intervention Type
Other
Intervention Name(s)
Gaze stability exercises
Intervention Description
Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.
Intervention Type
Other
Intervention Name(s)
Brandt-Daroff Exercises
Intervention 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.
Primary Outcome Measure Information:
Title
Dix Hall Pike Test
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.
Time Frame
Change from Baseline dizziness and balance to 2 Weeks
Title
Fukuda Step Test
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.
Time Frame
Change from Baseline dizziness to 2 Week
Title
Motion Sensitivity Quotient
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
Time Frame
Change from Baseline dizziness to 2 Week
Secondary Outcome Measure Information:
Title
Dizziness Handicap Inventory
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
Time Frame
Change from Baseline dizziness to 2 Week
Title
Sharpened Romberg's Test
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.
Time Frame
Change from Baseline balance to 2 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misbah Ghous, MSNMPT
Organizational Affiliation
Riphah International University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
. National Special Education Center Muzaffarabad department of social welfare & women development.
City
Muzaffarabad
State/Province
Azad Kashmir
ZIP/Postal Code
13100
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
21089986
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.
Results Reference
background
Citation
Lakhani H, Saxena PP, Shethia UJp. Effectiveness of Brandt-daroff exercises on hearing impaired children: A Comparative Study.2:100.
Results Reference
background
PubMed Identifier
20588090
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.
Results Reference
background
PubMed Identifier
17275927
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.
Results Reference
background
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Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
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