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

Sponsor
Ahram Canadian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05959967
Collaborator
(none)
100
1
2
7.2
13.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vestibular Rehabilitation Exercises
  • Behavioral: General Fitness Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to one of two groups: the VRE group or the GFT group.Participants are randomly assigned to one of two groups: the VRE group or the GFT group.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 25, 2023
Anticipated Primary Completion Date :
Feb 25, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT05959967
Other Study ID Numbers:
  • VRGFT2023
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2023