Vestibular Balance Therapy for Vestibular Disorders

(VBT-C Trial)

Overseen By Jill Meredith

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neurologic conditions, Illiteracy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a home-based vestibular balance therapy for children with vestibular hypofunction, which affects balance and coordination. The goal is to determine if these exercises are feasible at home and if they improve the condition. Participants will perform short daily exercises focused on eye movement and balance for eight weeks, with weekly check-ins from a physical therapist. Children with severe to profound hearing loss and recent vision screening, along with their caregivers, are well-suited for this study. Data from this trial will aid in designing a larger study to compare different treatments. As an unphased trial, this study allows participants to contribute to early research that could shape future treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this vestibular balance therapy is safe for children with vestibular hypofunction?

Studies have shown that vestibular balance therapy (VBT) is generally safe for people with balance and dizziness issues. Research on vestibular rehabilitation, similar to VBT, suggests it is well-tolerated. Patients often find relief from vertigo symptoms and experience improved balance.

One study found that vestibular therapy in emergency settings was practical and helped reduce dizziness over time. This suggests that even in busy environments, the therapy can be safe and effective.

Although these studies focus on adults, VBT is generally considered safe because exercises are tailored to each person's needs and abilities. Safety remains a priority, with trained professionals often guiding the initial sessions.

Overall, evidence indicates that VBT is a safe option for managing balance and dizziness, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vestibular Balance Therapy (VBT) for vestibular disorders because it offers a unique home-based approach that emphasizes active participation and family involvement. Unlike traditional therapies that might require clinical settings, VBT empowers caregivers to lead exercises at home, making it more accessible and less intimidating for children. The therapy focuses on improving gaze stabilization and balance through targeted exercises, which may enhance the overall effectiveness compared to standard treatments. This personalized and engaging method has the potential to not only improve physical outcomes but also increase the enjoyment and adherence to therapy, setting it apart from conventional options.

What evidence suggests that vestibular balance therapy is effective for vestibular disorders?

Research shows that vestibular balance therapy, which participants in this trial may receive, can greatly improve balance and reduce dizziness in people with vestibular disorders. Studies have found that this therapy helps people move more easily and feel less dizzy. After about six weeks of therapy, patients reported performing daily activities more easily and experiencing a better quality of life related to dizziness. Other research highlights similar positive effects on balance and reducing disability in people with long-term vestibular issues. These findings suggest that vestibular balance therapy could effectively help children with vestibular hypofunction by improving their balance and reducing dizziness. ^{5 6 7 8 9}

Who Is on the Research Team?

Jennifer B Christy, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with severe to profound hearing loss.

I am between 6 and 12 years old.

I have had a vision test in the last year or am willing to get one.

Exclusion Criteria

You have vision problems that can't be fixed and are not related to balance issues.

I am currently undergoing therapy for balance issues.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo a comprehensive battery of vestibular function and balance tests

1 week

1 visit (in-person)

Treatment

Participants engage in an 8-week home-based vestibular balance therapy program with weekly in-person checks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Intervention
• Vestibular Balance Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: VBP Intervention Group Experimental Treatment 1 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 Intervention Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Foundation for Physical Therapy Research

Collaborator

Trials

4

Recruited

1,600+

Foundation for Physical Therapy Research

Collaborator

Trials

3

Recruited

1,500+

Published Research Related to This Trial

Vestibular Rehabilitation Therapy (VRT) is an effective treatment for many patients with vestibular disorders and balance dysfunctions, helping to improve their symptoms.

The paper outlines various assessment methods and treatment strategies for VRT, emphasizing its importance in managing balance-related issues in patients seeking help from otolaryngologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the patient with dizziness and balance disorders. Girardi, M., Konrad, HR.[2005]

Vestibular physical therapy (VPT) is an evidence-based treatment aimed at reducing symptoms like vertigo, dizziness, and imbalance, which can significantly improve patients' quality of life.

The therapy emphasizes patient safety and includes fall risk assessments to prevent falls, making it a comprehensive approach to managing vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Physical Therapy and Fall Risk Assessment. Carender, WJ., Grzesiak, M., Telian, SA.[2021]

Combining vasoactive medical treatment with optokinetic and statokinetic training significantly improves the condition of patients with balance disorders, as measured by the modified Dizziness Handicap Inventory questionnaire.

The psychiatric status of patients plays a crucial role in the effectiveness of the rehabilitation program, indicating that mental health may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences with complex vestibular rehabilitation. Szirmai, A.[2015]

Vestibular rehabilitation therapy (VRT) significantly improves balance in stroke patients, with a standardized mean difference (SMD) of 0.59, particularly effective for those who had a stroke within the last 6 months (SMD of 0.56).

VRT also enhances gait function, showing a significant improvement in the Timed Up-and-Go test with a mean difference of -4.32 seconds, especially for patients who experienced a stroke within 6 months, indicating moderate certainty of its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy on balance and gait in patients after stroke: a systematic review and meta-analysis. Meng, L., Liang, Q., Yuan, J., et al.[2023]

Vestibular physical therapy is effective in managing symptoms of vestibular dysfunction, such as dizziness and imbalance, particularly for individuals with peripheral vestibular disorders, as supported by various studies including controlled trials.

Emerging evidence also suggests that vestibular rehabilitation may benefit individuals with central vestibular disorders, indicating its potential broader application in treating different types of vestibular dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on vestibular physical therapy. Alghadir, AH., Iqbal, ZA., Whitney, SL.[2022]

In a study of 69 patients with chronic unilateral vestibular hypofunction, vestibular rehabilitation therapy combined with Wii® therapy significantly reduced dizziness handicap, as shown by a decrease in the Dizziness Handicap Inventory score from a median of 40 to 24 (P<.0001).

The therapy also improved balance and visual stability, with the Dynamic Gait Index score increasing from a median of 21 to 23 and dynamic visual acuity improving from a median of 2 to 1, both with statistical significance (P<.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. Verdecchia, DH., Mendoza, M., Sanguineti, F., et al.[2022]

Supervised vestibular rehabilitation treatment programs generally show better outcomes in improving emotional status, dizziness, and balance in individuals with unilateral vestibular disorders, based on a systematic review of six randomized control trials.

However, the review did not find strong evidence that supervised programs are significantly superior to unsupervised or home-based training, highlighting limitations in the self-reported measures used in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. Lilios, A., Chimona, T., Nikitas, C., et al.[2023]

The study established the minimal clinically important difference (MCID) for the Activities-specific Balance Confidence Scale (ABC), Functional Gait Assessment (FGA), and Gait Speed (GS) in individuals with vestibular disorders, with values of 18.1%, 4 points, and 0.09 m/s respectively, based on a sample of 222 to 237 subjects.

These MCID values, derived using an anchor-based approach with the Dizziness Handicap Inventory (DHI) as a reference, provide important benchmarks for assessing meaningful improvements in gait and balance following vestibular rehabilitation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. Wellons, RD., Duhe, SE., MacDowell, SG., et al.[2022]

Vestibular physical therapy significantly improved balance and functional outcomes in 48 patients with central vestibular dysfunction, as shown by various assessment measures after an average of 5 therapy visits over 5 months.

Patients with severe disability at baseline experienced greater improvements, although those with cerebellar dysfunction showed the least progress, indicating that the type of vestibular dysfunction may influence therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for central vestibular dysfunction. Brown, KE., Whitney, SL., Marchetti, GF., et al.[2007]

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Review Article An update on vestibular physical therapy

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