Vibrotactile Balance Belt Effect on Improving Gait

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 80 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Impact of Vibrotactile Stimulation Via BalanceBelt and IMU-based Gait Analysis in Individuals With Balance Disorders

Conditions

Vestibular Hypofunction, Ataxia - Other, Gait Impairment

Being tested

BalanceBelt

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• BalanceBeltDevice

  The BalanceBelt is a lightweight, wearable device designed to assist individuals with balance impairments. It provides real-time vibrotactile feedback around the waist, which aligns with the user's posture and movements. By delivering sensory cues, the BalanceBelt aids users in maintaining stability and improving awareness of trunk tilt during daily activities. Its non-invasive design allows for continuous use and can be discreetly worn under clothing. The device aims to enhance safety, confidence, and independence for individuals with balance dysfunction, supporting both rehabilitation and long-term mobility improvements.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Dizziness Handicap Inventory (DHI)

   The Dizziness Handicap Inventory (DHI) is a validated patient-reported outcome measure designed to assess the perceived impact of dizziness on daily function. It includes 25 items categorized into physical, emotional, and functional domains, with responses scored on a scale from 0 (no impact) to 100 (maximum impact). Higher scores indicate greater disability.

   Measured: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months

2. Activities Balance Confidence Scale (ABC)

   The Activities Balance Confidence Scale (ABC) is a validated self-reported questionnaire designed to measure an individual's confidence in maintaining balance during various daily activities, such as walking on uneven surfaces, climbing stairs, or reaching overhead. The scale consists of 16 items, with each activity rated on a percentage scale from 0% (no confidence) to 100% (complete confidence). Higher scores indicate greater balance confidence.

   Measured: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months

3. Bilateral Vestibular Questionnaire (BVQ)

   The Bilateral Vestibular Questionnaire (BVQ) is a 54-item patient-reported outcome measure designed to assess the range of symptoms experienced by individuals with bilateral vestibular dysfunction and the impact on daily life. The questionnaire evaluates seven domains: imbalance, oscillopsia, other physical symptoms, cognition, emotion, behavioral changes and limitations, and social life. Each item is scored on a six-point Likert scale ranging from "never" to "always." Score range 0-324. Higher scores reflect greater symptom severity and reduced quality of life.

   Measured: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months

4. Single-Item and Visual Analog Scales (VAS)

   Single-item measures and Visual Analog Scales (VAS) will be used to assess specific aspects of participants' experiences and treatment responses. Each scale involves a numerical or visual rating system typically ranging from 0 to 10, or 0 to 100, depending on the domain being assessed. These scales measure variables such as limitations in daily life, perceived health, expectations for future recovery, and the overall effectiveness of previous rehabilitation therapies. A higher score indicates more positive outcomes or perceptions.

   Measured: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months

5. Video Head Impulse Test (vHIT)

   The Video Head Impulse Test (vHIT) is a clinical test used to assess the vestibulo-ocular reflex (VOR) by measuring eye movement responses to head rotations. This test evaluates the function of the three semicircular canals, providing insight into vestibular physiology. During the test, participants wear video goggles that record eye movements while the head is gently rotated to either side at a velocity of ~150°/s, consistent with standardized vHIT protocols. The primary outcome measure is VOR gain (eye velocity/head velocity), with lower gain values potentially indicating vestibular dysfunction.

   Measured: Baseline, 3 weeks, 1-2-3-4 months

6. Dynamic Visual Acuity (DVA)

   The Dynamic Visual Acuity (DVA) test is a validated clinical measure used to assess the ability to maintain clear vision during head movements. The test evaluates the vestibulo-ocular reflex (VOR) by comparing static visual acuity (head stationary) with visual acuity during dynamic head rotations in the horizontal and vertical planes (e.g., head movements right, left, up, and down). Participants are seated 2 meters from the testing screen, and head rotation speeds must reach a minimum of 80°/s to generate the randomized optotype. The primary measure is logMAR (logarithm of the minimum angle of resolution) scores, where higher logMAR values indicate worse visual acuity during movement.

   Measured: Baseline, 3 weeks, 1-2-3-4 months

7. Functional Gait Assessment (FGA)

   The Functional Gait Assessment (FGA) is a clinical tool used to evaluate gait performance in individuals during different walking tasks. It consists of 10 tasks, including walking while changing speeds, walking with head turns, walking backward, stepping over obstacles, and walking in tandem. Each task is scored on a 0-3 scale, with a total score range of 0-30 indicating optimal performance, and lower scores reflecting greater balance impairments and reduced gait functionality. The FGA is validated for identifying fall risk. Scores below 22/30 indicate fall risk in older adults.

   Measured: Baseline, 3 weeks, 1-2-3-4 months

8. Timed Up and Go (TUG)

   The Timed Up and Go (TUG) test is a validated tool for assessing functional mobility and fall risk. Participants are instructed to rise from a seated position, walk 3 meters, turn 180°, walk back, and return to a seated position. The time taken to complete the sequence is recorded as the primary outcome. Faster times indicate normal functional mobility, while slower times (>13.5 seconds for older adults) are indicative of increased fall risk, particularly in individuals with vestibular disorders.

   Measured: Baseline, 3 weeks, 1-2-3-4 months

9. Timed Up and Go Dual Task

   The Timed Up and Go Dual Task test is a dual-task modified version of the traditional TUG protocol, which further assesses the impact of cognitive load on mobility and balance. Participants perform the same tasks as the TUG test (stand, walk 3 meters, turn, and return to sit) while simultaneously counting backwards from 100 by threes (or another similar cognitive challenge). Timings exceeding 15 seconds in elderly individuals are associated with increased fall risk.

   Measured: Baseline, 3 weeks, 1-2-3-4 months

10. Gait Velocity (10-Meter Walk Test)

    Gait velocity will be measured using the 10-Meter Walk Test (10MWT), a validated assessment tool for evaluating walking speed during a self-selected comfortable pace over a short distance. Participants will be instructed to walk 10 meters while gait speed is recorded, with or without an assistive device as appropriate. The average speed (meters/second) is calculated and will be used as the primary outcome measure.

    Measured: Baseline, 3 weeks, 1-2-3-4 months

11. Sway energy and sway over time (Adaptation Test)

    The Adaptation Test assesses participants' ability to maintain stability and adapt to unexpected changes in surface tilt. Testing is conducted using a rotating force plate, which provides controlled motion stimuli in two directions: toes-up and toes-down. Participants will stand on the force plate while wearing the Virtualis Motion (VR) headset, which provides immersive visual environments to simulate balance challenges and enhance sensorimotor engagement. Postural stability is evaluated by measuring sway energy, which quantifies force and the extent of anterior-posterior sway, as well as sway over time, which measures center of pressure (COP) movement across the duration of the trials. These measures provide insight into a participant's balance control and adaptive strategies during repeated tilt trials.

    Measured: Baseline, 3 weeks, 1-2-3-4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Nov 2025
2. Study start20 Mar 2026
3. Primary completion1 Dec 2030 (estimated)
4. Study completion1 Dec 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (10)Papers the sponsor has linked to this study.
• Other trials for Vestibular HypofunctionStudies of the same condition, open and under way.
• More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.