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

Vestibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959967
• Other study ID #: VRGFT2023
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: July 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Vestibular Diseases
• Vestibular Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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