What side effects are associated with this type of intervention?

The most common treatments for Bilateral Vestibulopathy, such as home-based vestibular balance therapy programs, primarily involve targeted exercises to improve balance and vestibular function. Known side effects of these non-pharmacologic interventions can include temporary dizziness, nausea, and fatigue, especially during the initial stages of therapy as the body adjusts to the exercises. These side effects are generally mild and tend to diminish as the patient progresses with the therapy.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for treatments directly targeting Bilateral Vestibulopathy in the provided context. However, the context does discuss a home-based vestibular balance therapy program aimed at improving balance and vestibular function through targeted exercises. This type of rehabilitative approach is commonly used for vestibular disorders and focuses on exercises to enhance vestibular compensation and balance.

What other types of research exist?

Promising novel alternatives to home-based vestibular balance therapy for bilateral vestibulopathy patients include: 1) Virtual Reality (VR)-based vestibular rehabilitation, which uses immersive environments to enhance balance training; 2) Vestibular implant devices, which are surgically implanted to provide direct stimulation to the vestibular nerve; 3) Robotics-assisted gait training, which uses robotic exoskeletons to improve balance and coordination; and 4) Biofeedback-based balance training, which provides real-time feedback to patients to help them adjust their posture and movements.

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Vestibular Balance Therapy for Vestibular Disorders (VBT-C Trial)

N/A

Recruiting

Led By Jennifer B Christy, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of severe to profound SNHL

Age 6-12 years

Must not have

Currently receiving vestibular therapy

Neurologic condition other than SNHL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study period at 2 years

Summary

This trial tests a home-based balance therapy for children with hearing loss and balance issues. The program involves specific exercises done at home with regular therapist check-ins. It aims to see if the therapy is practical and beneficial for improving balance and coordination.

Who is the study for?

This trial is for children aged 6-12 with severe to profound sensorineural hearing loss (SNHL) who can commit, along with their caregiver, to an 8-week home-based vestibular balance therapy program. They must have had a vision test within the last year or be willing to undergo one. Children with other neurological conditions, poor reading or picture identification skills, current vestibular therapy, or uncorrected vision issues are not eligible.

What is being tested?

The study tests a home-based vestibular balance therapy designed for children with vestibular hypofunction. Over eight weeks, participants will perform exercises five times per week and have weekly check-ins with a physical therapist. The aim is to assess the feasibility of this program and its preliminary impact on function before planning a larger trial.

What are the potential side effects?

Since this intervention involves physical exercises at home under supervision rather than medication, side effects may include dizziness or imbalance during initial sessions but should improve as therapy progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with severe to profound hearing loss.

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I am between 6 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing therapy for balance issues.

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I have a neurological condition that is not sensorineural hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study period at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study period at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study period at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks

Change in Functional Gait Assessment at 4 and 8 weeks

Change in Sensory Organization Test at 4 and 8 weeks

Secondary study objectives

Management Feasibility (data entry)

Management Feasibility (training)

Participant Experience Feasibility (Enjoyment)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VBP Intervention GroupExperimental Treatment1 Intervention

Children coded as abnormal on functional tests (FT) (n=12) will participate in an 8-week 5X/week home-based VBT program. At the initial visit (T0), the PI will instruct the participants (caregiver and child) in the program and provide all materials. The exercises will be led by the caregiver, with weekly in person checks by the PI to progress and provide coaching. The child/caregiver will complete a daily log to report activities and level of enjoyment. VBT will be done 5 days/week and will include 4 key categories of exercises, each lasting 5 minutes (20 minutes total of exercise per day). The 4 categories, explained below, include: 1) Times 1 (X1) Viewing, 2) Gaze Shifting, 3) Static Balance, 4) Dynamic Balance. The proposed VBT home program will include 10 minutes of gaze stabilization exercises, and 10 minutes of balance training.

Group II: Sham InterventionPlacebo Group1 Intervention

Sham Intervention (not to be compared to intervention - for feasibility only): Aim 1 is to establish the feasibility of a control intervention to be used in future studies. Therefore, 3 participants who score above the set criterion for the Functional Tests (FT) (i.e., they do not need VBT) will participate in an 8-week sham intervention. At T0, the PI will instruct the participants to do the sham intervention, led by the caregiver with weekly checks to control for attention bias. The sham intervention will be done for 20 minutes per day and will consist of 10 minutes of focused reading a book of the child's choice and 10 minutes of active play. The child and caregiver will complete a daily activity log documenting the activity and level of enjoyment.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The home-based vestibular balance therapy program for Bilateral Vestibulopathy focuses on improving balance and vestibular function through targeted exercises. These exercises typically include gaze stabilization, balance training, and habituation exercises. Gaze stabilization exercises help improve the control of eye movements, which is crucial for maintaining clear vision during head movements. Balance training enhances the body's ability to maintain stability and prevent falls by strengthening the muscles and improving coordination. Habituation exercises reduce dizziness by gradually exposing patients to movements that provoke their symptoms, thereby desensitizing their vestibular system. These mechanisms are vital for Bilateral Vestibulopathy patients as they help compensate for the loss of vestibular function, improve daily functioning, and enhance overall quality of life.

Manual therapy with and without vestibular rehabilitation for cervicogenic dizziness: a systematic review.