HEARING IMPAIRED CHILDRENNCT04413084
Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
A study testing Gaze stability exercises and Brandt-Daroff Exercises in people with HEARING IMPAIRED CHILDREN, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- HEARING IMPAIRED CHILDREN
- What is being tested?
- Gaze stability exercises and Brandt-Daroff Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
. National Special Education Center Muzaffarabad department of social welfare & women development.
Muzaffarabad, Azad Kashmir, 13100
About this study
Official title: Effects of Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
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.
Read the 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.
- Conditions
- HEARING IMPAIRED CHILDREN
- Being tested
- Gaze stability exercises, Brandt-Daroff Exercises
- Keywords
- Dizziness, Hearing Impaired children, Vestibular rehabilitation
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze stability exercisesOther
Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.
Brandt-Daroff ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gaze stability exercises | Experimental | Group I will receive Gaze stability exercises. Receives: Other: Gaze stability exercises |
| Brandt-Daroff Exercises | Experimental | Group II will receive Brandt-Daroff Exercises. Receives: Other: Brandt-Daroff Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline dizziness and balance to 2 Weeks
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.
Measured: Change from Baseline dizziness to 2 Week
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
Measured: Change from Baseline dizziness to 2 Week
Secondary outcomes (2)
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
Measured: Change from Baseline dizziness to 2 Week
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.
Measured: Change from Baseline balance to 2 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Aug 2020
- Primary completion1 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HEARING IMPAIRED CHILDRENStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413084
- Sponsor's protocol ID
- REC/00653 Poshmal butt
- Status last verified
- Mar 2021
- First submitted
- 14 Apr 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 21089986Lakhani H, Saxena PP, Shethia UJp. Effectiveness of Brandt-daroff exercises on hearing impaired children: A Comparative Study.2:100.
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.
PubMed 20588090Suarez 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.
PubMed 17275927
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Rehabilitation for Dizziness in Hearing Impaired Children.
- ClinicalTrials.gov ID
- NCT04413084
- Acronym / sponsor ID
- REC/00653 Poshmal butt
- Conditions
- HEARING IMPAIRED CHILDREN
- Keywords
- Dizziness, Hearing Impaired children, Vestibular rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gaze stability exercises | Experimental | Other: Gaze stability exercisesGroup I will receive Gaze stability exercises. |
| Brandt-Daroff Exercises | Experimental | Other: Brandt-Daroff ExercisesGroup II will receive Brandt-Daroff Exercises. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaze stability exercisesBusiness card will be placed at eye level. Begin with simpler exercises and progress toward harder one. | Other | Gaze stability exercises |
| Brandt-Daroff ExercisesBrandt-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. | Other | Brandt-Daroff Exercises |
Primary outcome
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.
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.
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
2 secondary outcomes
Dizziness Handicap Inventory
Time frame: Change from Baseline dizziness to 2 Week
Sharpened Romberg's Test
Time frame: Change from Baseline balance to 2 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- BackgroundKhandare 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.
- Background: PubMed 21089986Hsiao CJ, Cherry DK, Beatty PC, Rechtsteiner EA. National Ambulatory Medical Care Survey: 2007 summary. Natl Health Stat Report. 2010 Nov 3;(27):1-32.
- BackgroundLakhani H, Saxena PP, Shethia UJp. Effectiveness of Brandt-daroff exercises on hearing impaired children: A Comparative Study.2:100.
- Background: PubMed 20588090Hall 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.
- Background: PubMed 17275927Suarez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ghous, MSNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze stability exercises and Brandt-Daroff Exercises in people with HEARING IMPAIRED CHILDREN, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dix Hall Pike Test (time frame: Change from Baseline dizziness and balance to 2 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04413084, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.