Vestibular DisorderNCT06303310
Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction
A study testing Gaze Stability Exercises, Optokinetic Exercises and Routine Physical Therapy in people with Vestibular Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Gaze Stability Exercises, Optokinetic Exercises and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2024to 30 Sep 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be of both genders. Participants age will be between 23 to 63 years. Participants diagnosed with unilateral vestibular disorders by ENT specialist. Individuals who have MOCA score ≤26. Participants with positive head thrust test. Participants with positive supine roll test.
- Participants have one or more of the following characteristics:
- Related burden symptoms that affected their daily activities. A history of dizziness/vertigo triggered by head or body movement.
Who cannot join
- Individuals with a history of neurological or psychological deficit. Individuals with the diagnosis of benign paroxysmal positional vertigo as individuals.
- Individuals who had a previous surgery that could affect balance or cause dizziness.
- Individuals with orthopedic problems that prohibited the performance of the exercise and that impact one's balance and walking pattern.
- Individuals who report spontaneous episodes of dizziness, which are not worsened by movements Individuals which are completely dependent on the assistive device during mobility.
- Imbalance due to diabetic neuropathy.
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahawal Victoria Hospital
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
Official title: Comparative Effects of Gaze Stability Exercises and Optokinetic Exercises on Dizziness, Balance and Activities of Daily Living in Patients With Vestibular Hypofunction
This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities.
Read the detailed description
Vestibular hypofunction characterized by impaired balance and spatial orientation due to the inner ear's vestibular system issues present significant challenges for affected individuals. Gaze stability exercises enhance focus despite head movements while optokinetic exercises improve eye movement control. Both interventions benefit people with vestibular issues aiming to enhance stability, decrease dizziness and improve balance. This study aims to investigate and compare the effects of gaze stability exercises and optokinetic exercises on dizziness, balance, and activities of daily living in patients with vestibular hypofunction.
This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.
The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities. Assessment will be carried out at baseline, 2nd and 4th week. The data will be analyzed using SPSS version 24 for Windows software with the significance level set at p = 0.05. Shapiro-Wilk test will assess data normality. Between group analysis will utilize the Independent t-test for parametric data and Mann-Whitney test for non-parametric data. Within group comparisons will employ repeated measure ANOVA Paired t- test for parametric data and Friedman ANOVA for non-parametric data.
- Conditions
- Vestibular Disorder
- Being tested
- Gaze Stability Exercises, Optokinetic Exercises, Routine Physical Therapy
- Keywords
- Optokinetic exercises, Vestibular hypofunction,
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze Stability ExercisesOther
Also called Optokinetic Exercises
Group A ( Gaze Stability Exercise+ Routine Physical Therapy) Group A will receive gaze stability exercises consist of 5 structured components for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks.(16)
Optokinetic ExercisesOther
Group B (Optokinetic Exercises+Routine Physical Therapy) Group B will receive optokinetic exercises for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks
Routine Physical TherapyOther
Routine Physical Therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will receive gaze stability exercises consist of 5 structured components for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks. Receives: Other: Gaze Stability Exercises; Other: Routine Physical Therapy |
| Group B | Experimental | Group B will receive optokinetic exercises for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks. Receives: Other: Optokinetic Exercises; Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
The Dizziness Handicap Inventory sees widespread use in evaluating disability associated with dizziness.The DHI comprises 25 questions, with seven pertaining to physical aspects, nine to the emotional domain, and nine to functional aspects.
Measured: At Baseline, 2nd week and 4th week
Mini-Bestest
Mini Balance Evaluation Systems Test is used to evaluate the balance performance. It consists of 14 tasks, each scored on a three-level scale: 0 for severe inability to perform, 1 for moderate performance, and 2 for normal performance, resulting in a total possible score of 28.
Measured: At Baseline, 2nd week and 4th week.
Modified-Clinical Test of Sensory Interaction on Balance
The Clinical Test of Sensory Interaction on Balance was specifically designed to evaluate how the visual, somatosensory, and vestibular systems contribute to postural control.Individuals experiencing uncompensated peripheral vestibular loss might encounter challenges in maintaining an upright posture, particularly when there are alterations in visual input and support surface conditions. Prior to the test, patients are positioned on the platform designated for the evaluation. Throughout each phase of the assessment, patients are instructed to stand steadily and sustain their position on the platform for 30 seconds. The duration of time the patients remained standing is documented during each trial, repeated three times in total, and an average is calculated based on these three trials
Measured: At Baseline, 2nd week and 4th week.
Vestibular Disorders Activities of Daily Living Scale
The Vestibular Disorders Activities of Daily Living Scale holds significant importance as it focuses on examining daily activities that may be adversely affected by vestibular disorders.Comprising 28 items, the subscales are categorized into three sections: Functional (F), Ambulation (A), and Instrumental (E).(7) Each activity within the assessment employs a qualitative scale ranging from 0 to 10 points.
Measured: At Baseline, 2nd week and 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Feb 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies 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
- Model description
- Group A (Gaze Stability Exercises + Balance Exercises) Group B (Optokinetic Exercises + Balance Exercises)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PHD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303310
- Sponsor's protocol ID
- REC/RCR&AHS/23/0296
- Status last verified
- Oct 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Gaze Stability Exercises and Optokinetic Exercises on Dizziness, Balance and Activities of Daily Living in Patients With Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT06303310
- Acronym / sponsor ID
- REC/RCR&AHS/23/0296
- Conditions
- Vestibular Disorder
- Keywords
- Optokinetic exercises, Vestibular hypofunction,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Mar 2024 (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.
This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities.
Detailed description
Vestibular hypofunction characterized by impaired balance and spatial orientation due to the inner ear's vestibular system issues present significant challenges for affected individuals. Gaze stability exercises enhance focus despite head movements while optokinetic exercises improve eye movement control. Both interventions benefit people with vestibular issues aiming to enhance stability, decrease dizziness and improve balance. This study aims to investigate and compare the effects of gaze stability exercises and optokinetic exercises on dizziness, balance, and activities of daily living in patients with vestibular hypofunction.
This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.
The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities. Assessment will be carried out at baseline, 2nd and 4th week. The data will be analyzed using SPSS version 24 for Windows software with the significance level set at p = 0.05. Shapiro-Wilk test will assess data normality. Between group analysis will utilize the Independent t-test for parametric data and Mann-Whitney test for non-parametric data. Within group comparisons will employ repeated measure ANOVA Paired t- test for parametric data and Friedman ANOVA for non-parametric data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A (Gaze Stability Exercises + Balance Exercises) Group B (Optokinetic Exercises + Balance Exercises)
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Gaze Stability Exercises, Other: Routine Physical TherapyGroup A will receive gaze stability exercises consist of 5 structured components for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks. |
| Group B | Experimental | Other: Optokinetic Exercises, Other: Routine Physical TherapyGroup B will receive optokinetic exercises for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants will be of both genders. Participants age will be between 23 to 63 years. Participants diagnosed with unilateral vestibular disorders by ENT specialist. Individuals who have MOCA score ≤26. Participants with positive head thrust test. Participants with positive supine roll test.
- Related burden symptoms that affected their daily activities. A history of dizziness/vertigo triggered by head or body movement.
Key exclusion criteria (6 listed)
- Individuals with a history of neurological or psychological deficit. Individuals with the diagnosis of benign paroxysmal positional vertigo as individuals.
- Individuals who had a previous surgery that could affect balance or cause dizziness.
- Individuals with orthopedic problems that prohibited the performance of the exercise and that impact one's balance and walking pattern.
- Individuals who report spontaneous episodes of dizziness, which are not worsened by movements Individuals which are completely dependent on the assistive device during mobility.
- Imbalance due to diabetic neuropathy.
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 ExercisesAlso: Optokinetic ExercisesGroup A ( Gaze Stability Exercise+ Routine Physical Therapy) Group A will receive gaze stability exercises consist of 5 structured components for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks.(16) | Other | Group A |
| Optokinetic ExercisesGroup B (Optokinetic Exercises+Routine Physical Therapy) Group B will receive optokinetic exercises for 20 minutes and the routine physical therapy consisting of balance exercises of 20 minute for 5 days a week for 4 weeks | Other | Group B |
| Routine Physical TherapyRoutine Physical Therapy | Other | Group A, Group B |
Primary outcome
Dizziness Handicap Inventory
Time frame: At Baseline, 2nd week and 4th week
The Dizziness Handicap Inventory sees widespread use in evaluating disability associated with dizziness.The DHI comprises 25 questions, with seven pertaining to physical aspects, nine to the emotional domain, and nine to functional aspects.
Mini-Bestest
Time frame: At Baseline, 2nd week and 4th week.
Mini Balance Evaluation Systems Test is used to evaluate the balance performance. It consists of 14 tasks, each scored on a three-level scale: 0 for severe inability to perform, 1 for moderate performance, and 2 for normal performance, resulting in a total possible score of 28.
Modified-Clinical Test of Sensory Interaction on Balance
Time frame: At Baseline, 2nd week and 4th week.
The Clinical Test of Sensory Interaction on Balance was specifically designed to evaluate how the visual, somatosensory, and vestibular systems contribute to postural control.Individuals experiencing uncompensated peripheral vestibular loss might encounter challenges in maintaining an upright posture, particularly when there are alterations in visual input and support surface conditions. Prior to the test, patients are positioned on the platform designated for the evaluation. Throughout each phase of the assessment, patients are instructed to stand steadily and sustain their position on the platform for 30 seconds. The duration of time the patients remained standing is documented during each trial, repeated three times in total, and an average is calculated based on these three trials
Vestibular Disorders Activities of Daily Living Scale
Time frame: At Baseline, 2nd week and 4th week.
The Vestibular Disorders Activities of Daily Living Scale holds significant importance as it focuses on examining daily activities that may be adversely affected by vestibular disorders.Comprising 28 items, the subscales are categorized into three sections: Functional (F), Ambulation (A), and Instrumental (E).(7) Each activity within the assessment employs a qualitative scale ranging from 0 to 10 points.
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 15 Oct 2024.
- 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.
Muhammad Kashif, PHD study chair
Riphah International University
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, Optokinetic Exercises and Routine Physical Therapy in people with Vestibular Disorder, 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 3 inclusion and 6 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 15 Oct 2024. 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?
Dizziness Handicap Inventory (time frame: At Baseline, 2nd week and 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.