Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04842474 |
| Other study ID # |
NadaSalehAldawsary |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2021 |
| Est. completion date |
January 2022 |
Study information
| Verified date |
April 2021 |
| Source |
King Saud University |
| Contact |
Nada S Aldawsary, MSc |
| Phone |
00966 543485121 |
| Email |
442204518[@]student.ksu.edu.sa |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Gaze stability exercise is a medical procedure for persons with unilateral vestibular
disturbances such as vestibular neuritis or persons who have had tumors of their 8th nerve.
They are a crucial part of the vestibular dysfunction rehabilitation protocols in health
centers. These activities which involve turning one's eyes at different angles while having
their eyes focused on an optotype are aimed at helping improve the vestibular ocular reflex
(VOR), visual acuity during head movements and also reducing vertigo and dizziness.
Study aim:
This review will be establishing the effectiveness of applying gaze stability with balance
exercises procedure among participants who are suffering vertigo due to vestibular neuritis.
Methods:
Twenty volunteers between the age of 25-59 years old, diagnosed, and confirmed to be
suffering from vestibular neuritis and vertigo will be used in this study. Gaze stability
exercises will be performed while patients are in a seated position. Each exercise will last
for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement,
pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance
exercises will be performed in a standing position including both static and dynamic training
with or without closing eyes. The following outcome measures for each participant will be
assessed pre-and post-treatment after completing four weeks of intervention. They include;
Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale), Arabic version
of Dizziness Handicap Inventory (A-DHI), Berg Balance Scale (BBS), and Katz Index of
Independence in Activities of Daily Living (Katz ADL). The findings will then be subjected to
statistical methods and data analysis using the SPSS toolkit.
In this study we hypothesis that practicing gaze stability and balance exercises will have a
positive influence on balance and activities of daily living among vestibular neuritis
patients.
Description:
Balance and stability are important components for daily activities. Individuals need
appropriate posture and coordination of various body parts for them to perform basic
movements needed when doing various activities. The body requires a strong balance to perform
day-to-day activities such as walking up and downstairs, bending, as well as lifting things
from the ground. Lack of this balance, which can occur because of ear infections, accidents,
and aging, generally can result in decreased quality of life. Nichols-Larsen et al., (2016)
mentioned that vestibular neuritis is the second most common cause of vertigo and patients
are complained of balance disturbance after head movements. Most healthcare facilities as
well as health fitness centers use exercises to improve balance and stability in patients
with balance problems. Examples of such balance exercises include gaze stability exercises.
This literature reviews the effectiveness of gaze stability with balance exercises in
enhancing balance, activities of daily living and reducing the risk of falling among patients
suffering from vertigo due to vestibular neuritis in Riyadh.
2.1. Overview of Gaze Stability Exercises Gaze stability exercises are part of vestibular
rehabilitation therapy exercises. The exercises have become part of healthcare plans for
patients with vestibular dysfunction . The exercises aim at improving vestibular ocular
reflex (VOR), visual acuity during head movements, as well as reducing vertigo and dizziness.
The therapy also improves postural stability, hence improving the quality of life among those
affected. This, in turn, helps the patients achieve their activities of daily living.
Gaikward mentions that the therapy works by promoting and stimulating vestibular adaptation
and substitution to various stimuli provided during the exercises. Horizontal and vertical
head movements with a fixed vision on a certain target induce retinal slip, which in turn
increases the gain of vestibular response. However, achieving sustained vestibular response
requires repeated exercises. Thus, most gaze stability exercises are prescribed for a long
duration to achieve this response. Commonly used prescription is about four to five exercises
in a day. The total exercises should last for an average of thirty minutes.
2.2. Effectiveness of Gaze Stability Exercises There are several studies and researches on
vestibular rehabilitation therapy. A systematic analysis of most of these studies shows gaze
stability exercises to be effective in achieving balance and postural stability. A recent
study by Roh and Lee (2019) found a positive correlation between vestibular rehabilitation
therapy and the improvement of balance and stability. According to their results, dynamic
postural stability among patients with balance problems significantly improved after
providing gaze stability exercises twice per week for four weeks. The researchers used
various forms of gaze stability exercises, including, eyeball, pursuit, saccadic, and
vergence eye movements as well as vestibular ocular reflex exercise. Thus, these exercises
proved effective in reducing vertigo, dizziness, and achieving balance among those affected.
Vestibular rehabilitation therapy also improves the overall health status of affected
individuals as well as increasing the quality of their life. Tsukamoto et al., (2015) found
an improvement in the quality of life among twenty patients diagnosed with vestibular
disease. The intensity of dizziness also improved among these patients, with postural
stability and balance improving in more than eight percent of the patients. Thus, the
negative impacts of various vestibular diseases, including vestibular neuritis, can be
minimized by prescribing well-coordinated and supervised gaze stability exercises.
Khanna and Singh (2014) saw related findings in another study. However, according to their
results, improvement in postural stability and balance requires repeated exposure to
interventions for a significant duration. The duo provided gaze stability exercises for two
consecutive days per week for a duration of six weeks. The patients conducted the exercises
three times per day with each session lasting for forty to sixty minutes. Moreover,
vestibular rehabilitation therapy to be more effective if two or more types of exercises can
be combined during the interventions. Those who were receiving balance training in addition
to gaze stability exercises had a significant improvement in their balance and stability
compared to those receiving either of the two therapies alone.
Although vestibular rehabilitation therapy is generally effective, some studies have shown a
negative side of them. According to Luth et al., (2019), the therapy is only effective for a
short term, hence making them less effective than conservative as well as medical therapy.
According to the researchers, vestibular rehabilitation therapy works only for a maximum of
three weeks. The findings in this study can limit the use of vestibular rehabilitation
therapy, including gaze stability exercises in those with long-term disabilities. However,
combining various forms of exercises may remove this weakness, hence making vestibular
rehabilitation therapy an interesting area for future researches.
2.3. Vestibular Rehabilitation in Saudi Arabia There is a consensus among scholars over a
recently published study that presents concise and well-researched investigations on
vestibular rehabilitation therapy. The study discusses vestibular rehabilitation therapy and
its positive effects on vestibular dysfunction patients. Furthermore, this study stresses
Vestibular rehabilitation as an effective form of therapy in alleviating the symptoms of
various vestibular diseases such as vestibular neuritis. The therapeutic exercises are
beneficial in attaining post stability and improving balance in patients with balance issues.
However, studying the application of the combination of gaze stability and balance exercises
to improve daily living activities in patients suffering from vertigo with vestibular
neuritis in Saudi Arabia poses challenges since there is a lack of published data in the
department of Saudi Arabia. There are a few qualified specialists in Saudi Arabia practicing
VRT besides it is not commonly used in local physiotherapy departments. The pandemic of Covid
19- has made it difficult for patients to receive physical therapy services that enhance
telerehabilitation role. Therefore, this research designs need to look for ways to overcome
those limitations by integrating other forms of exercises such as gaze stability and balance
exercises with vestibular neuritis patients through telerehabilitation.
According to the existing literature, vestibular rehabilitation therapy is effective in
alleviating the symptoms of various vestibular diseases such as vestibular neuritis. The
exercises are useful in achieving postural stability and improving balance among patients
with balance issues. However, the studies have some limitations since most of the researchers
did not follow up on their participants for long enough to ensure they had long-term
remissions. Thus, there is an opportunity to conduct more studies to ascertain the
effectiveness of gaze stability exercises including the quality of patients' life among Saudi
population. This literature aims to assess whether conducting gaze stability with balance
exercises has an improvement influence on balance and reducing falling incidence. Moreover,
to study the impact of applying combination of gaze stability and balance exercises to
improve activities of daily living in patients suffering from vertigo with vestibular
neuritis in Saudi Arabia.
3 Methods
3.1. Study design This research is experimental with Pre-post cohort design, Pilot clinical
trial, by using telerehabilitation.
3.2. Participants Adults of 25-59 years old suffering vertigo due to vestibular neuritis.
Through the following criteria, all participants will be eligible to attend the study.
3.2.1. Inclusion/exclusion criteria A convenience volunteers of adults of 25-59 years old are
diagnosed with vestibular neuritis and vertigo. Participants should not be either with a
previous history of neurological diseases or brain surgery affecting equilibrium. Both male
and female are cognitively intact. Subjects with medical issues, e.g., hypertension and
diabetes, are undertaking medication regularly. Independent participants or those requiring
reasonable assistance, but with balance disturbance in daily living activities and
transferring, having Berg Balance Scale between 21-56 are included in the study.
However, subjects with the inability to follow instructions or completely dependent on the
assistive device during mobility have been eliminated from the study. Participants with
chronic dizziness diagnosed specifically with benign paroxysmal positional vertigo (BPPV), or
Meniere's disease are excluded. The research will be applied locally in Saudi Arabia, and all
participants will sign a consent form approved by the Ethics Committee of King Saud
University.
3.3. Sample size Twenty convenient volunteers of adults of 25-59 years old (n=20) are
diagnose with vestibular neuritis and vertigo. The sample size is the same as previous
studies.
3.4. Intervention The gaze stability exercises (GSEs) and balance exercises (BE) are
described by Roh& Lee (2019) and Khanna& Singh (2014), respectively. This research is
reconstructed by combining two forms of exercises (GSEs)& (BE). Participants with vestibular
neuritis and vertigo will be practicing a combination of gaze stability exercise (GSEs) and
balance exercises (BE).
Gaze stability exercises are included in five phases: eyeball movement, saccadic eye
movement, pursuit eye movement, vengeance eye movement, and vestibular-ocular reflex
exercise. The eyeball exercise moves the eyes to a different direction slowly while they are
closed to the left and right, up and down, rotation movements. The saccadic eye movement
exercise moves the eyes as quickly as possible between the stationary points with a fixed
head. The pursuit eye movement exercise by tracking slowly moving target with the eyes
without moving head. The vergence eye movement exercise includes tracking the moving target
from 5 cm close to eye level to as far as possible, both backward and forward. The
vestibular-ocular reflex exercise keeps the eyes on the fixed point while moving the head
from left to right. Gaze stability exercises will be performed while patients are seated, and
each exercise lasts for 30 seconds.
Balance exercises, both static and dynamic with or without closing eyes, are recommended to
improve postural stability. In the first two weeks, patients will perform balance exercises
with opening eyes, and then in the next couple of weeks, participants will do the same
exercises with closing eyes. It involves standing on a firm surface with feet apart, heel
stand, toe stand, marching on a firm surface, semi tandem stand, walking forward and backward
with a normal support base.
This intervention of gaze stability with balance exercises will be given as scheduled in the
treatment plan. It will be applied twice each alternative day with ten repetitions for a
total treatment period of four weeks. Each session will last for 45-60 minutes. Rest interval
is between two groups of exercises for five minutes. Warm-up and cool down for five minutes
is applicable before and after completing the treatment session. The patients will be
followed up weekly through tele rehabilitation under the supervision of the researcher.
3.5. Outcome measures The following outcome measures for each participant will be evaluated
before the commencement of treatment and at the end of four weeks of training. They include;
Arabic version of Activities-Specific Balance Confidence Scale (A-ABC scale) to measure
patient self-confidence for performing activities of daily living without losing balance.
Permission has been granted from original author Dr. Alia Alghwiri by email to use the Arabic
version of the ABC scale. It has proved its good reliability and validity and can be used
with the Arab population's vestibular disorders.
Moreover, Arabic version of the dizziness handicap inventory questionnaire is used to assess
the impact of dizziness on activity of participants.
In addition, Berg Balance Scale (BBS) to evaluate static balance and fall risk in adult. It
has shown good reliability and validity with vestibular patients too.
Moreover, Katz Index of Independence in Activities of Daily Living (Katz ADL) to define
problems in performing ADLs. It has demonstrated excellent validity and reliability to assess
the ability to perform daily living activities independently in adult and older
community-dwelling populations.
3.6. Data analysis Data will be collected, tabulated, and analyzed using SPSS version 25. The
descriptive data will be represented as mean (M) and standard deviation (SD) or frequency and
percent. Paired t-test will be run to compare pre-intervention and post-intervention scores
of A-ABC, BBS& Katz-ADL for each participant. Pearson's r regression will be used to detect
the linear association between variables. Results will be statistically significant at p
<0.05.
