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Vestibular HypofunctionBalanceBeltNCT07253532

Vibrotactile Balance Belt Effect on Improving Gait

A study testing BalanceBelt in people with Vestibular Hypofunction and Ataxia - Other, run by Johns Hopkins University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will examine the effect of using a vibrotactile feedback implemented into a belt, at improving gait in those with gait disorders. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
BalanceBelt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesUnited States
Study dates
20 Mar 2026to 1 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Age 18-80 years old
  • Waist between 60 and 120 cm
  • Intact vibration sensitivity around the waist
  • Balance disorder and/or a diagnosis of ataxia or vestibular dysfunction (diagnosis based on imaging, clinical and family history, vestibular function tests, and/or genetic testing)
  • Speak English

Who cannot join

  • Previous Vestibular Rehabilitation Therapy (VRT) finished less than 2 months ago
  • Inability to stand or walk slowly without support in the light on a firm underground
  • Neurological, ophthalmological and/or orthopedic disorders that hampers vestibular, oculomotor or gait and posture examination

Trial locations and contacts

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

Michael Craig Schubert, PhD contact

4109559567

mschube1@jhmi.edu

United States2 sites, 2 recruiting

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21287

    Recruiting

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

    Jennifer Millar, MSPT, 410-955-0016, jmillar1@jhmi.edu

    Michael C Schubert, PhD, 410-955-7381, mschube1@jhmi.edu

    Recruiting

Other trials in United States

About this study

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

This study will examine the effect of using a vibrotactile feedback implemented into a belt, at improving gait in those with gait disorders.

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.

Study groups in NCT07253532
Study groupRoleWhat they receive
Balance Disorders Group with Vibrotactile Stimulation via Balance BeltExperimentalParticipants 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.
Receives: Device: BalanceBelt
Healthy Controls Group (Age/Gender-Matched Participants Without Balance Disorders)No interventionParticipants 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.

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

Secondary outcomes (8)

  1. Oscillopsia Functional Index (OFI)

    The Oscillopsia Functional Index (OFI) is a 43-item patient-reported outcome measure designed to quantify the functional impact of oscillopsia symptoms on various activities of daily living. Participants rate level of difficulty across tasks such as walking, riding in a car, recognizing faces, and navigating environments. Each item is scored on a scale from 0 (no symptoms or difficulty) to 5 (unable to perform the activity due to symptoms), with additional options for marking activities as "not applicable." Total OFI scores range from 0 to 215, with higher scores indicating greater impairment.

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

  2. Falls Efficacy Scale - International (FES-I)

    The Falls Efficacy Scale - International (FES-I) is a widely validated self-reported questionnaire designed to assess a participant's concern about falling during a variety of daily physical and social activities. It consists of 16 items covering tasks performed both inside and outside the home, such as cleaning, shopping, and walking. Each item is rated on a 4-point Likert scale ranging from "Not at all concerned" (1) to "Very concerned" (4), resulting in a total score range of 16-64, with higher scores indicating greater concerns about falling.

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

  3. EQ-5D-5L Quality of Life Questionnaire

    The EQ-5D-5L is a standardized instrument for measuring health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on five levels ranging from "no problems" to "extreme problems," creating a profile of a participant's health status. Additionally, participants complete a Visual Analog Scale (VAS) to rate overall health from 0 ("worst imaginable health") to 100 ("best imaginable health").

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

  4. Vestibular Evoked Myogenic Potential (VEMP)

    The Vestibular Evoked Myogenic Potential (VEMP) test is a clinical measure used to assess the function of the vestibular system, focusing specifically on the otolith organs (utricle and saccule). VEMP includes two types: cervical VEMP (cVEMP), which assesses saccular function through responses from the sternocleidomastoid neck muscle, and ocular VEMP (oVEMP), which evaluates utricular function through responses from the orbicularis oculi eye muscles. Participants are positioned reclined and equipped with electrodes over the relevant muscles. Auditory stimuli, such as clicks or tone bursts, are delivered via earphones to each ear individually, and participants are asked to lift the head (cVEMP) or look upward (oVEMP) to optimize muscle activation. Test results include latency and amplitude of evoked potential responses, with reduced or absent responses indicating possible vestibular dysfunction.

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

  5. Vestibular Nystagmogram (VNG)

    The Vestibular Nystagmogram (VNG) is a standard clinical test used to evaluate the function of the vestibular system, particularly the horizontal semicircular canal. It involves recording participants' eye movements while wearing video goggles designed to track nystagmus (involuntary eye movements) in response to various stimuli. Participants follow an infrared light with the eyes during certain conditions, and nystagmus responses are evaluated after exposure to both cold air and warm air stimuli administered into the ear canal.

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

  6. Scale for Ocular Motor Disorders in Ataxia (SODA)

    The Scale for Ocular Motor Disorders in Ataxia (SODA) is a clinical rating tool designed to quantify and characterize ocular motor dysfunction in patients with cerebellar ataxia and related disorders. SODA systematically evaluates a range of oculomotor deficits, including gaze-holding and smooth pursuit abnormalities, saccadic dysmetria (hypometria and hypermetria), saccade velocity and restriction, gaze-evoked and spontaneous nystagmus (horizontal and vertical), saccadic oscillations, and abnormalities in the vestibulo-ocular reflex (VOR). Each domain is scored based on the observed severity and type of deficit. Higher SODA scores correspond to more severe ocular motor dysfunction.

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

  7. Dynamic Gait Index (DGI)

    The Dynamic Gait Index (DGI) is a validated clinical tool used to assess gait, balance, and fall risk during dynamic walking tasks. The DGI includes 8 tasks, such as walking while changing speeds, turning the head, stepping over obstacles, and pivoting. Each task is scored on a 0-3 scale, with a total maximum score of 24 indicating optimal performance, and lower scores reflecting greater gait and balance impairments. A score below 19/24 indicates a significantly increased risk of falls (2.58 times greater likelihood of falling within the previous 6 months).

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

  8. Scale for the Assessment and Rating of Ataxia (SARA)

    The Scale for the Assessment and Rating of Ataxia (SARA) is a validated clinical tool designed to quantify the severity of ataxia symptoms. SARA consists of 8 tasks that evaluate various aspects of motor function, including gait, stance, sitting, and limb coordination (such as finger chase, nose-finger tests, and heel-shin tests). Each task is rated on a 0-4 scale, with total scores ranging from 0 (no ataxia) to 40 (most severe ataxia). Lower scores reflect minimal impairment, while higher scores indicate greater dysfunction.

    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

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The investigators will have a group of people affected by vestibular disorders. The people affected by vestibular disorders will then be compared to a group of healthy controls.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253532
Sponsor's protocol ID
IRB00530950
Acronym
BalanceBelt
Status last verified
Mar 2026
First submitted
19 Nov 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kingma H, Hougaard DD, van de Berg R. Subconscious vibrotactile stimulation improves mobility and balance in patients with bilateral vestibulopathy: adherence over 2 years. Front Neurol. 2024 Oct 8;15:1491195. doi: 10.3389/fneur.2024.1491195. eCollection 2024.

    PubMed 39440249

  • Kingma H, Felipe L, Gerards MC, Gerits P, Guinand N, Perez-Fornos A, Demkin V, van de Berg R. Vibrotactile feedback improves balance and mobility in patients with severe bilateral vestibular loss. J Neurol. 2019 Sep;266(Suppl 1):19-26. doi: 10.1007/s00415-018-9133-z. Epub 2018 Dec 5.

    PubMed 30519776

  • Hegeman J, Honegger F, Kupper M, Allum JH. The balance control of bilateral peripheral vestibular loss subjects and its improvement with auditory prosthetic feedback. J Vestib Res. 2005;15(2):109-17.

    PubMed 15951624

  • Dozza M, Chiari L, Horak FB. Audio-biofeedback improves balance in patients with bilateral vestibular loss. Arch Phys Med Rehabil. 2005 Jul;86(7):1401-3. doi: 10.1016/j.apmr.2004.12.036.

    PubMed 16003671

  • Chiari L, Dozza M, Cappello A, Horak FB, Macellari V, Giansanti D. Audio-biofeedback for balance improvement: an accelerometry-based system. IEEE Trans Biomed Eng. 2005 Dec;52(12):2108-11. doi: 10.1109/TBME.2005.857673.

    PubMed 16366234

  • Guyot JP, Perez Fornos A, Guinand N, van de Berg R, Stokroos R, Kingma H. Vestibular assistance systems: promises and challenges. J Neurol. 2016 Apr;263 Suppl 1:S30-5. doi: 10.1007/s00415-015-7922-1. Epub 2016 Apr 15.

    PubMed 27083882

  • Beylergil SB, Karmali F, Wang W, Bermudez Rey MC, Merfeld DM. Vestibular roll tilt thresholds partially mediate age-related effects on balance. Prog Brain Res. 2019;248:249-267. doi: 10.1016/bs.pbr.2019.04.019. Epub 2019 May 24.

    PubMed 31239136

  • Lucieer F, Vonk P, Guinand N, Stokroos R, Kingma H, van de Berg R. Bilateral Vestibular Hypofunction: Insights in Etiologies, Clinical Subtypes, and Diagnostics. Front Neurol. 2016 Mar 4;7:26. doi: 10.3389/fneur.2016.00026. eCollection 2016.

    PubMed 26973594

  • Starkov D, Strupp M, Pleshkov M, Kingma H, van de Berg R. Diagnosing vestibular hypofunction: an update. J Neurol. 2021 Jan;268(1):377-385. doi: 10.1007/s00415-020-10139-4. Epub 2020 Aug 7.

    PubMed 32767115

  • van Stiphout L, Szmulewicz DJ, Guinand N, Fornos AP, Van Rompaey V, van de Berg R. Bilateral vestibulopathy: a clinical update and proposed diagnostic algorithm. Front Neurol. 2023 Dec 19;14:1308485. doi: 10.3389/fneur.2023.1308485. eCollection 2023.

    PubMed 38178884

Questions about this trial

What is this clinical trial studying?

A study testing BalanceBelt in people with Vestibular Hypofunction and Ataxia - Other, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Craig Schubert, PhD (4109559567, mschube1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dizziness Handicap Inventory (DHI) (time frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07253532, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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