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

NCT05959967 | Unknown

• 1 other identifier: VRGFT2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

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

  Baseline and 8 weeks

• Change in Flexibility Test Scores from Baseline to 8 Weeks

  Baseline and 8 weeks

Study Arms (2)

Vestibular Rehabilitation Exercises (VRE)

EXPERIMENTAL

The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training.

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.

Behavioral: General Fitness Training

Interventions

Vestibular Rehabilitation Exercises BEHAVIORAL

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.

Vestibular Rehabilitation Exercises (VRE)

General Fitness Training BEHAVIORAL

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.

General Fitness Training (GFT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Model Details: Participants are randomly assigned to one of two groups: the VRE group or the GFT group.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 25, 2023
• Study Start: July 25, 2023
• Primary Completion: February 25, 2024
• Study Completion: March 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)