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

The Efficacy of Vestibular Rehabilitation Exercises and General Fitness Training pn Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibular Disorder
• Intervention / Treatment: Behavioral: Vestibular Rehabilitation Exercises; Behavioral: General Fitness Training

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

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 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: Vestibular Rehabilitation Exercises (VRE); The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training.	Behavioral: Vestibular Rehabilitation Exercises; The VRE group will receive exercises aimed at improving gaze stability, postural control, and balance. This includes activities like gaze stabilization exercises, balance training on different surfaces, and walking with head movements.
Active Comparator: General Fitness Training (GFT); The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training.	Behavioral: General Fitness Training; The GFT group will undertake exercises to enhance cardiovascular fitness, strength, and flexibility, such as light aerobic exercises, resistance training, and stretching. The exercise sessions will be 60 minutes in duration, consisting of a warm-up phase, the main exercise phase, and a cool-down phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 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.	Changes between Baseline and 8 weeks
Change in Biodex Balance System Scores from Baseline to 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.	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 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.	Baseline and 8 weeks
Change in Flexibility Test Scores from Baseline to 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.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2023
• Primary Completion (Estimated): February 25, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Sensation Disorders; Dizziness; Vestibular Diseases
• Other Study ID Numbers: VRGFT2023

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