Use of a Vibrotactile Balance Belt System for Vestibular Rehabilitation in the Pediatric Population

Overseen By Alicia Wang, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Developmental delay, Unable to stand

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special vibrating belt to help children with balance problems. The belt gives gentle vibrations to guide their movements during exercises. Researchers want to see if this belt helps more than regular balance exercises alone.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Vestibular Rehabilitation/Balance Belt treatment safe for humans?

The research on vestibular rehabilitation, which includes exercises to help with balance and dizziness, does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does this treatment differ from other treatments for vestibular dysfunction?

This treatment is unique because it combines traditional vestibular rehabilitation with virtual reality or Wii® therapy, which can enhance the rehabilitation process by making exercises more engaging and potentially more effective in improving balance and reducing dizziness. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Vestibular Rehabilitation/Balance Belt?

Research shows that vestibular rehabilitation can help improve balance and reduce dizziness in people with vestibular disorders, which may lower the risk of falls. ^{2 10 11 12 13}

Who Is on the Research Team?

Jacob R Brodsky, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

English speaking

Understanding of how to use the device

Intention to complete full 3 months of vestibular rehabilitation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo weekly vestibular rehabilitation sessions for 3 months, with experimental subjects also using the vibrotactile balance belt

12 weeks

12 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

• Vestibular Rehabilitation/Balance Belt

How Is the Trial Designed?

Group I: Vestibular Rehabilitation/Balance Belt Experimental Treatment 1 Intervention

Subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of 12 sessions). They will undergo standard balance training exercises with the physical therapists like the control group, but will also undergo an additional 15 minutes of Balance Belt exercises during each session.

Group II: Standard Vestibular Rehabilitation Active Control 1 Intervention

Subjects will undergo weekly vestibular rehabilitation sessions for 3 months (a total of 12 sessions of an hour each). During these sessions, standard balance training exercises will be done at the discretion of the physical therapists.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

A study of 70 patients over 50 years old showed that vestibular rehabilitation therapy significantly improved balance, as measured by the Berg balance test, with scores increasing from 36.8 to 46.4 after therapy.

The therapy effectively reduces fall risk in at-risk elderly patients, demonstrating its importance as a preventive measure, with improvements observed immediately at the end of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of vestibular rehabilitation therapy in reducing falls. Macias, JD., Massingale, S., Gerkin, RD.[2022]

A randomized controlled trial with 42 patients showed that a 4-week customized exercise program significantly improved symptoms, disability, balance, and postural stability in individuals with chronic unilateral vestibular dysfunction.

In contrast, the control group that did not receive any treatment showed no significant improvements, highlighting the efficacy of vestibular rehabilitation exercises in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. Giray, M., Kirazli, Y., Karapolat, H., et al.[2022]

In a study involving 81 patients with chronic unilateral vestibular hypofunction, a combined exercise protocol (adaptation and habituation exercises) led to significantly better improvements in balance and self-perceived disability compared to single-exercise protocols after 8 weeks.

The combined exercise group showed faster improvements in functional gait and dynamic postural stability, indicating that a multi-faceted approach to vestibular rehabilitation may be more effective than focusing on just one type of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Vestibular Rehabilitation Modalities in Unilateral Vestibular Hypofunction: A Prospective Study. Lilios, A., Chimona, T., Papadakis, C., et al.[2023]

Vestibular rehabilitation is an effective intervention for individuals with balance and vestibular disorders, aimed at improving functional abilities and reducing dizziness symptoms.

The program includes specific exercises and outcome measures to track progress, while also identifying factors that can positively or negatively influence recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of vestibular physical therapy rehabilitation. Whitney, SL., Sparto, PJ.[2023]

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]

In a study of 20 patients with unilateral vestibular hypofunction, virtual reality (VR) vestibular rehabilitation was evaluated and compared to conventional therapy, showing promising results in improving symptoms of vertigo.

Both VR and conventional therapy groups reported significant improvements in their symptoms, indicating that VR may be an effective alternative for vestibular rehabilitation, although specific statistical outcomes were not detailed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. Stankiewicz, T., Gujski, M., Niedzielski, A., et al.[2021]

Vestibular rehabilitation significantly improved the diagnosis of vestibular peripheral disorders, with 75% of participants showing a transition to normal vestibular patterns.

The Brazilian Dizziness Handicap Inventory (DHI) proved to be an effective tool for assessing changes in quality of life and diagnosing vestibular disorders in individuals undergoing rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study about the benefits of vestibular rehabilitation in peripheral vestibular disorders]. Segarra-Maegaki, JA., Taguchi, CK.[2015]

Adding virtual reality-based home exercises to conventional vestibular rehabilitation significantly improved vestibulo-ocular reflex gain and posturography scores in patients with unilateral vestibular hypofunction, with the mixed-method group showing a gain score of 0.71 compared to 0.64 in the conventional group after one year.

Patients who engaged in virtual reality exercises reported greater improvements in their dizziness-related quality of life, as indicated by a Dizziness Handicap Inventory score of 24.34 versus 35.73 in the conventional group, highlighting the efficacy of this approach in long-term rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of vestibular rehabilitation and head-mounted gaming task procedure in unilateral vestibular hypofunction: a 12-month follow-up of a randomized controlled trial. Viziano, A., Micarelli, A., Augimeri, I., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Early Vestibular Rehabilitation in Patients With Acute Vestibular Disorder: A Systematic Review and Meta-Analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of vestibular rehabilitation therapy in reducing falls. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

[Effectiveness of Self-efficacy Promoting Vestibular Rehabilitation Program for Patients with Vestibular Hypofunction]. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Different Vestibular Rehabilitation Modalities in Unilateral Vestibular Hypofunction: A Prospective Study. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Principles of vestibular physical therapy rehabilitation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Outcome analysis of individualized vestibular rehabilitation protocols. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Vestibular Rehabilitation on Balance Control in Older People with Chronic Dizziness: A Randomized Clinical Trial. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality Vestibular Rehabilitation in 20 Patients with Vertigo Due to Peripheral Vestibular Dysfunction. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. [2018]

12. Brazil pubmed.ncbi.nlm.nih.gov

[Study about the benefits of vestibular rehabilitation in peripheral vestibular disorders]. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Long-term effects of vestibular rehabilitation and head-mounted gaming task procedure in unilateral vestibular hypofunction: a 12-month follow-up of a randomized controlled trial. [2019]