Vibrotactile Balance Belt Effect on Improving Gait (BalanceBelt)

Johns Hopkins University

Status: Begins enrollment this month

Conditions: Vestibular Hypofunction; Ataxia - Other; Gait Impairment

Treatments: Device: BalanceBelt

Study type: Interventional

Funder types: Other

Identifiers

NCT07253532

IRB00530950

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Balance Disorders Group with Vibrotactile Stimulation via Balance Belt

Experimental group

Description:

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.

Treatment:

Device: BalanceBelt

Healthy Controls Group (Age/Gender-Matched Participants Without Balance Disorders)

No Intervention group

Description:

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.