Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction

Not Applicable

Recruiting

• Conditions: Vestibular Disorder
• Interventions: Behavioral: Vestibular Rehabilitation Exercises; Behavioral: General Fitness Training

• Registration Number: NCT05959967
• Lead Sponsor: Ahram Canadian University

Brief Summary

The goal of this clinical trial is to compare the effectiveness of Vestibular Rehabilitation Exercises (VRE) and General Fitness Training (GFT) in adults diagnosed with vestibular disorders. The main questions it aims to answer are:

Does VRE lead to better improvements in gaze stabilization, balance, and gait than GFT? Does GFT lead to more improvements in overall fitness than VRE? Participants will be randomly assigned to either the VRE or GFT group and will participate in 60-minute exercise sessions twice weekly for 8 weeks. Researchers will compare the improvements in the two groups to see which intervention is more effective.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study Start: 2023-07-25
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-02-25
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male or female participants aged 18 - 60 years.
• Diagnosis of a vestibular disorder confirmed by a healthcare professional.
• Able to walk unassisted for at least 10 meters.
• Able to understand and comply with the procedures of this study.
• Willing to provide informed consent.

Exclusion Criteria

• Severe cardiovascular, respiratory, or metabolic disease that contraindicates physical exercise.
• Neuromuscular disorders that may affect balance and mobility other than the diagnosed vestibular disorder.
• History of orthopedic surgery within the past 6 months.
• Currently participating in another interventional clinical trial.
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular Rehabilitation Exercises (VRE)	Vestibular Rehabilitation Exercises	The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training.
General Fitness Training (GFT)	General Fitness Training	The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training.

Primary Outcome Measures

Name	Time	Method
Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks	Changes between Baseline and 8 weeks	This outcome is the difference in scores on the Vertigo Symptom Scale (VSS), a validated vestibular symptom questionnaire, from baseline to 8 weeks. The VSS has two components: a vertigo/balance scale, with a score range of 0-36, and an autonomic/anxiety scale, with a score range of 0-28. Higher scores on both scales indicate more severe symptoms.
Change in Biodex Balance System Scores from Baseline to 8 Weeks	Baseline and 8 weeks	This outcome is the difference in scores on the Biodex Balance System, a validated tool for balance assessment, from baseline to 8 weeks. The Biodex Balance System assesses participants' ability to maintain postural control through a variety of tests, including the Stability Index, Fall Risk Test, and Postural Stability Test. Lower scores on the Stability Index indicate better balance, while lower scores on the Fall Risk and Postural Stability tests indicate lower risk of falling and better postural stability, respectively.

Secondary Outcome Measures

Name	Time	Method
Change in Flexibility Test Scores from Baseline to 8 Weeks	Baseline and 8 weeks	This outcome is the difference in scores on a standard flexibility test, such as the Sit and Reach Test, from baseline to 8 weeks. The test assesses the flexibility of the lower back and hamstring muscles. A greater reach distance or score indicates better flexibility.
Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks	Baseline and 8 weeks	This outcome is the difference in the distance covered during the Six-Minute Walk Test (6MWT) from baseline to 8 weeks. The 6MWT assesses the maximum distance that can be walked in 6 minutes. A greater distance indicates better cardiovascular fitness.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt