BalanceBelt for Gait Impairment

(BalanceBelt Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Recent VRT, Inability to walk, Neurological disorders

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

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the BalanceBelt to help individuals with balance problems walk better. The belt uses gentle vibrations to guide and improve balance and movement. People with balance disorders, such as ataxia (loss of full control of body movements) or vestibular dysfunction (inner ear balance issues), may qualify if they can feel vibrations around their waist and have not recently undergone vestibular therapy. Healthy individuals without balance issues are also needed as a comparison group. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance balance treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that the BalanceBelt is safe for improving gait in those with gait disorders?

Research has shown that the BalanceBelt is well-received by users with balance problems. One study found that 31 out of 39 participants reported improved balance and mobility after just two hours of use. This positive feedback suggests the belt is easy to use. No reports of harmful effects have emerged, indicating a good safety profile. However, since this trial is not in a specific phase, detailed safety information might still be limited. Prospective participants should inquire about any possible risks before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for balance disorders, which often rely on physical therapy and medication to manage symptoms, the BalanceBelt introduces a new approach by using vibrotactile stimulation. This wearable belt provides real-time feedback to users, helping them improve their balance and mobility through compensatory cues. Researchers are excited about the BalanceBelt because it offers a non-invasive and drug-free alternative that directly enhances the user's sensory perception of balance, potentially leading to more immediate and noticeable improvements in gait and stability.

What evidence suggests that the BalanceBelt is effective for improving gait in those with gait disorders?

Research has shown that the BalanceBelt, which participants in this trial may receive, can help people with balance problems improve their stability and movement. In an earlier study, users of the BalanceBelt increased their average Mobility and Balance Score from 4.2 to 7.9. Additionally, about 79% of participants noticed positive changes in their balance and movement after wearing the belt for just two hours. Another study found that the belt could improve stability by up to 200%. These early results suggest that the BalanceBelt could be a useful tool for helping people with balance issues walk better. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer Millar, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with balance and walking difficulties due to vestibular hypofunction, which affects their inner ear balance system. Participants should have a gait impairment or loss of coordination.

Inclusion Criteria

Speak English

Waist between 60 and 120 cm

Intact vibration sensitivity around the waist

Exclusion Criteria

I completed vestibular rehabilitation therapy less than 2 months ago.

I have a condition affecting my balance or eye movements.

I cannot stand or walk slowly without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including Dizziness Handicap Inventory, Activities Balance Confidence Scale, and other baseline measures

1 week

1 visit (in-person)

Treatment

Participants with balance disorders wear a vibrotactile stimulation belt to improve balance and mobility

3 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BalanceBelt

Trial Overview The study is testing the BalanceBelt, a device that uses vibration feedback to help improve walking stability in people with gait disorders.

How Is the Trial Designed?

Group I: Balance Disorders Group with Vibrotactile Stimulation via Balance Belt Experimental Treatment 1 Intervention

Participants with balance disorders will wear a vibrotactile stimulation belt (Balance Belt) designed to provide compensatory cues to improve balance and mobility. Physiologic, kinematic, and behavioral responses will be assessed using methods such as the video head impulse test (vHIT), the Dynamic Visual Acuity Test (DVA), and wearable inertial measurement unit (IMU) sensors to measure gait kinematics.

Group II: Healthy Controls Group (Age/Gender-Matched Participants Without Balance Disorders) Active Control 1 Intervention

Participants in the Healthy Controls Group are age- and gender-matched individuals without balance disorders. These participants will serve as a comparison group and will not receive any interventions. The participant's physiologic, kinematic, and behavioral measures will be assessed using the same testing protocols as the experimental group, including the video head impulse test (vHIT), the Dynamic Visual Acuity Test (DVA), and clinical/kinematic evaluations using inertial measurement unit (IMU) sensors.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. balancebelt.net balancebelt.net/en/

BalanceBelt – Smart Wearable Aid for Balance Disorders What clinical evidence supports the BalanceBelt? · Significant improvement in Mobility and Balance Score (from 4.2 to 7.9) · Up to 200% improvement in stability ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07253532?lastUpdPost=2020-10-10_

Vibrotactile Balance Belt Effect on Improving Gait This study will examine the effect of using a vibrotactile feedback implemented into a belt, at improving gait in those with gait disorders.

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

Vibrotactile feedback improves balance and mobility in ... Thirty-one out of the 39 patients experienced the effect of the belt on their balance and mobility as positive in a preselection trial of 2 h in ...

4. balancebelt.net balancebelt.net/en/veda/

Stable walking for people with a balance problem 31 out of 39 people experienced a positive effect after using the BalanceBelt for only 2 hours. The average Mobility and Balance Score increased from 4.2 to 7.9 ...

5. elitacwearables.com elitacwearables.com/elitac-wearables-launches-the-balancebelt-a-revolutionary-wearable-for-people-suffering-from-severe-balance-disorders/

Elitac Wearables launches the BalanceBelt, a ... A wearable that uses haptic feedback to help patients suffering from severe Bilateral Vestibular Loss find their balance and regain their independence.

6. medicaldevicenavigator.com medicaldevicenavigator.com/balancebelt_clinical_trial_gait_recovery/

Clinical Trial Investigates Vibrotactile Technology for Gait ... Researchers are investigating whether regular use of BalanceBelt can restore confidence and stability in walking for patients diagnosed with ...