Vestibular DisorderNCT05959967
Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction
A study testing Vestibular Rehabilitation Exercises and General Fitness Training in people with Vestibular Disorder, run by Ahram Canadian University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Vestibular Rehabilitation Exercises and General Fitness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
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
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.
- Conditions
- Vestibular Disorder
- Being tested
- Vestibular Rehabilitation Exercises, General Fitness Training
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation ExercisesBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation Exercises (VRE) | Experimental | The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training. Receives: Behavioral: Vestibular Rehabilitation Exercises |
| General Fitness Training (GFT) | Active comparator | The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training. Receives: Behavioral: General Fitness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start25 Jul 2023 (estimated)
- Primary completion25 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two groups: the VRE group or the GFT group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959967
- Sponsor's protocol ID
- VRGFT2023
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05959967
- Acronym / sponsor ID
- VRGFT2023
- Conditions
- Vestibular Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups: the VRE group or the GFT group.
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Exercises (VRE) | Experimental | Behavioral: Vestibular Rehabilitation ExercisesThe VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training. |
| General Fitness Training (GFT) | Active comparator | Behavioral: General Fitness TrainingThe GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation ExercisesThe 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. | Behavioural | Vestibular Rehabilitation Exercises (VRE) |
| General Fitness TrainingThe 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. | Behavioural | General Fitness Training (GFT) |
Primary outcome
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.
2 secondary outcomes
Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Change in Flexibility Test Scores from Baseline to 8 Weeks
Time frame: Baseline and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation Exercises and General Fitness Training in people with Vestibular Disorder, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks (time frame: Changes between Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.