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

NCT ID: NCT06303310

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-09-30

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.

Conditions

Vestibular Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Gaze Stability Exercises

Intervention Type: OTHER

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)

Routine Physical Therapy

Intervention Type: OTHER

Routine Physical Therapy

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.

Group Type: EXPERIMENTAL

Optokinetic Exercises

Intervention Type: OTHER

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 Therapy

Intervention Type: OTHER

Routine Physical Therapy

Interventions

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)

Intervention Type: 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

Intervention Type: OTHER

Routine Physical Therapy

Routine Physical Therapy

Intervention Type: OTHER

Other Intervention Names

Optokinetic Exercises

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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• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Kashif, PHD

Role: STUDY_CHAIR

Riphah International University

Locations

Bahawal Victoria Hospital

Chak Eighty-seven -Twelve Left, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/RCR&AHS/23/0296

Identifier Type: -

Identifier Source: org_study_id