Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Disorder
• Intervention / Treatment: Other: Gaze Stability Exercises; Other: Routine Physical Therapy; Other: Optokinetic Exercises

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Bahāwalpur, Punjab, Pakistan, 63100
      • Bahawal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Other: Gaze Stability 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); Other Names: Optokinetic Exercises; Other: Routine Physical Therapy; Routine Physical Therapy
Experimental: Group B; 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: Routine Physical Therapy; Routine Physical Therapy; Other: Optokinetic Exercises; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	At Baseline, 2nd week and 4th week.

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Muhammad Kashif, PhD, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Optokinetic exercises, Vestibular hypofunction,
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: REC/RCR&AHS/23/0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No