Balance Belt for Vestibular Disorders

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special balance belt designed to assist children with balance problems due to vestibular (inner ear) issues. Researchers compare the progress of children doing standard balance exercises to those using this new belt, the Vestibular Rehabilitation/Balance Belt, alongside their regular therapy. The goal is to determine if the belt significantly enhances recovery. Children referred for balance rehabilitation at Boston Children's Hospital who can use the device might be suitable candidates. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative therapy while contributing to valuable research.

Will I have to stop taking my current medications?

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

What prior data suggests that the vibrotactile balance belt is safe for use in children with vestibular impairment?

Research has shown that using a vibrotactile balance belt, such as the Sensory Kinetics Balance Rehabilitation System (SKBRS), is generally safe for improving balance and movement. One study found that 51% of patients improved after using a similar balance belt during therapy for balance issues. Although some patients did not experience significant changes, no major safety problems were reported.

Other studies have examined the effects of these belts on balance and overall function, and they have not identified any serious safety issues. Since this trial tests a new way to use a balance belt, the safety information from similar devices is reassuring. However, participants should still discuss any concerns with their doctors before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vibrotactile Balance Belt system for vestibular rehabilitation in children because it offers a novel approach to improving balance and coordination. Unlike standard vestibular rehabilitation, which relies solely on exercises guided by physical therapists, this system includes additional 15-minute Balance Belt exercises that provide real-time feedback through vibrations. This innovative method aims to enhance the effectiveness of traditional exercises by helping kids better understand and correct their body movements, potentially leading to quicker and more noticeable improvements in balance.

What evidence suggests that the vibrotactile balance belt is effective for vestibular rehabilitation?

Research has shown that vestibular rehabilitation can greatly improve quality of life and reduce dizziness for people with balance issues. One study found that after a few weeks of this therapy, patients performed better on tests measuring daily activities and dizziness. Another study discovered that this therapy also helps improve balance in children with hearing problems. In this trial, participants will either receive standard vestibular rehabilitation or undergo additional exercises with the Balance Belt. Although specific data on the vibrotactile balance belt (SKBRS) is limited, this technology is designed to enhance traditional vestibular exercises, which are already known to be helpful. This belt might provide extra support in regaining balance and stability during rehabilitation. ^{3 6 7 8 9}

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4490916/

Effectiveness of a Vestibular Rehabilitation Protocol to ... Results There was improvement in quality of life (p < 0.001) and intensity of dizziness (p = 0.003) with the intervention. An improvement of postural balance ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10938910/

Efficacy of vestibular rehabilitation and its facilitating and ... After the median of 6 (4–6) weeks of rehabilitation, DHI and VADL scores significantly improved in patients with either peripheral or central ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040663

Impact of Vestibular Rehabilitation and Dual‐Task Training ... The evidence supports that VRT, can probably improve balance, and DTT may improve gait outcomes among survivors of late subacute and chronic stroke.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587624000855

Efficacy of vestibular rehabilitation program in children with ... Conclusions. Vestibular-balance rehabilitation intervention positively impacts vestibular and balance functions in hearing-impaired children. ; Demographic data.

5. gulhanemedj.org gulhanemedj.org/articles/comparison-of-the-effectiveness-of-vestibular-rehabilitation-on-disability-and-balance-in-patients-with-chronic-unilateral-and-bilateral-vestibular-hypofunction/gulhane.galenos.2024.79026

Comparison of the effectiveness of vestibular rehabilitation ... The results of the present study showed that supervised 4-week vestibular rehabilitation had similar positive effects on disability and balance in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6722250/

Vibrotactile feedback improves balance and mobility in ... Improvement after vestibular rehabilitation therapy was noted in 18 patients (51%), whereas 12 (34%) showed little or no change and 5 (15%) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06300840

Vibrotactile Feedback Belt in Patients With Unilateral ... The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6129357/

Patient-Reported and Performance Outcomes Significantly ... Conclusion. The functional outcome measures reported, including TUG, gait speed, and DHI, reflect statistically significant improvements in elderly patients ...

9. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/counter/pdf/10.1186/s12916-023-03029-9.pdf?utm_source=consensus

Vestibular rehabilitation therapy on balance and gait in ... Data on the intervention details and outcome measures were also extracted. Any disagreements about the study selection and data extraction were discussed until ...