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Clinical Trials/NCT05959967
NCT05959967
Recruiting
N/A

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

Ahram Canadian University1 site in 1 country100 target enrollmentJuly 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vestibular Disorder
Sponsor
Ahram Canadian University
Enrollment
100
Locations
1
Primary Endpoint
Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2023
End Date
March 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in Flexibility Test Scores from Baseline to 8 Weeks(Baseline and 8 weeks)
  • Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks(Baseline and 8 weeks)

Study Sites (1)

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