Back to resultsVestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction
Primary Purpose
Vestibular Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vestibular Rehabilitation Exercises
General Fitness Training
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Disorder
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.
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vestibular Rehabilitation Exercises (VRE)
General Fitness Training (GFT)
Arm Description
The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training.
The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05959967
Brief Title
Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Anticipated)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of two groups: the VRE group or the GFT group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vestibular Rehabilitation Exercises (VRE)
Arm Type
Experimental
Arm Description
The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training.
Arm Title
General Fitness Training (GFT)
Arm Type
Active Comparator
Arm Description
The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training.
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Rehabilitation Exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General Fitness Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks
Description
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.
Time Frame
Changes between Baseline and 8 weeks
Title
Change in Biodex Balance System Scores from Baseline to 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Flexibility Test Scores from Baseline to 8 Weeks
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction
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