Vibrotactile Balance Belt Effect on Improving Gait

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • BalanceBelt

    Device

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Balance Disorders Group with Vibrotactile Stimulation via Balance BeltExperimental treatment 1 intervention
Group B: Healthy Controls Group (Age/Gender-Matched Participants Without Balance Disorders)No intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months

Secondary outcomes

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.

Time frame
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.

Time frame
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").

Time frame
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.

Time frame
Baseline, 3 weeks, 1-2-3-4 months

Other outcomes

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