Recruiting

Vibrotactile Feedback

Sponsor:

Johns Hopkins University

Code:

NCT07253532

Conditions

Vestibular Hypofunction

Ataxia - Other

Gait Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

BalanceBelt

Study Details

Brief summary:

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

Conditions

Vestibular Hypofunction

Ataxia - Other

Gait Impairment

Study ID

NCT07253532

Start date

Mar 20, 2026

Status verified date

Mar, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Balance Disorders Group with Vibrotactile Stimulation via Balance Belt

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.

no intervention: Healthy Controls Group (Age/Gender-Matched Participants Without Balance Disorders)

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.

Interventions

BalanceBelt

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.

Primary outcome measure

  • Dizziness Handicap Inventory (DHI) [ Time Frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months ]
  • Activities Balance Confidence Scale (ABC) [ Time Frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months ]
  • Bilateral Vestibular Questionnaire (BVQ) [ Time Frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months ]
  • Single-Item and Visual Analog Scales (VAS) [ Time Frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months ]
  • Video Head Impulse Test (vHIT) [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]
  • Dynamic Visual Acuity (DVA) [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]
  • Functional Gait Assessment (FGA) [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]
  • Timed Up and Go (TUG) [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]
  • Timed Up and Go Dual Task [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]
  • Gait Velocity (10-Meter Walk Test) [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]
  • Sway energy and sway over time (Adaptation Test) [ Time Frame: Baseline, 3 weeks, 1-2-3-4 months ]

Central Contacts and Locations

Central contacts

Michael Craig Schubert, PhD

4109559567mschube1@jhmi.edu

Locations

Johns Hopkins Medical Institutions

Recruiting

Baltimore, Maryland, United States, 21287

Johns Hopkins Outpatient Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jennifer Millar, MSPT

410-955-0016jmillar1@jhmi.edu

Michael C Schubert, PhD

410-955-7381mschube1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-27.