Clinical trial NCT06303310: Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction
Official title: Comparative Effects of Gaze Stability Exercises and Optokinetic Exercises on Dizziness, Balance and Activities of Daily Living in Patients With Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Keywords: Optokinetic exercises, Vestibular hypofunction,
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A (Gaze Stability Exercises + Balance Exercises) Group B (Optokinetic Exercises + Balance Exercises)
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: At Baseline, 2nd week and 4th week
measure: Mini-Bestest
timeFrame: At Baseline, 2nd week and 4th week.
measure: Modified-Clinical Test of Sensory Interaction on Balance
timeFrame: At Baseline, 2nd week and 4th week.
measure: Vestibular Disorders Activities of Daily Living Scale
timeFrame: At Baseline, 2nd week and 4th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: Bahawal Victoria Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif, PHD
role: STUDY_CHAIR
References: