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

NCT ID: NCT05959967

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Vestibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to one of two groups: the VRE group or the GFT group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vestibular Rehabilitation Exercises (VRE)

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

Group Type EXPERIMENTAL

Vestibular Rehabilitation Exercises

Intervention Type 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.

General Fitness Training (GFT)

The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training.

Group Type ACTIVE_COMPARATOR

General Fitness Training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

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Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed M ElMeligie, Ph.d

Role: CONTACT

+201064442032

Facility Contacts

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Mohamed M ElMeligie, Ph.d

Role: primary

01064442032

Other Identifiers

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VRGFT2023

Identifier Type: -

Identifier Source: org_study_id

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