15 Participants Needed

Vestibular Balance Therapy for Vestibular Disorders

(VBT-C Trial)

MA
JM
Overseen ByJill Meredith
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of Vestibular Balance Therapy for Vestibular Disorders?

Research shows that vestibular physical therapy, which is similar to Vestibular Balance Therapy, can help reduce symptoms like dizziness and imbalance in people with vestibular disorders. It also emphasizes the importance of fall prevention and improving quality of life.12345

How is Vestibular Balance Therapy different from other treatments for vestibular disorders?

Vestibular Balance Therapy is unique because it focuses on specialized exercises to improve balance and reduce dizziness by retraining the brain to compensate for inner ear deficits, unlike other treatments that may rely more on medication or surgery. This therapy emphasizes exercises that target both the vestibulo-ocular (eye movement) and vestibulospinal (balance and posture) pathways, making it a comprehensive approach to managing vestibular disorders.16789

What is the purpose of this trial?

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.

Research Team

JB

Jennifer B Christy, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.
My child and I agree to follow through with the balance therapy at home.
See 1 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

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+

Findings from Research

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

References

Vestibular Physical Therapy and Fall Risk Assessment. [2021]
Vestibular rehabilitation therapy on balance and gait in patients after stroke: a systematic review and meta-analysis. [2023]
Estimating the minimal clinically important difference for balance and gait outcome measures in individuals with vestibular disorders. [2022]
The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. [2023]
Physical therapy for central vestibular dysfunction. [2007]
An update on vestibular physical therapy. [2022]
Experiences with complex vestibular rehabilitation. [2015]
Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. [2022]
Vestibular rehabilitation therapy for the patient with dizziness and balance disorders. [2005]
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