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Recruiting NCT07253532

Vibrotactile Balance Belt Effect on Improving Gait

No phase Interventional Vestibular Hypofunction Ataxia - Other Gait Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BalanceBelt.
Who it may be relevant to
Registry conditions: Vestibular Hypofunction, Ataxia - Other, Gait Impairment. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device 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, confiden

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • Oscillopsia Functional Index (OFI) [Time frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months]
  • Falls Efficacy Scale - International (FES-I) [Time frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months]
  • EQ-5D-5L Quality of Life Questionnaire [Time frame: Baseline, 3 weeks, 1-2-3-4-5-11-23-35 months]
  • Vestibular Evoked Myogenic Potential (VEMP) [Time frame: Baseline, 3 weeks, 1-2-3-4 months]
  • Vestibular Nystagmogram (VNG) [Time frame: Baseline, 3 weeks, 1-2-3-4 months]
  • Scale for Ocular Motor Disorders in Ataxia (SODA) [Time frame: Baseline, 3 weeks, 1-2-3-4 months]
  • Dynamic Gait Index (DGI) [Time frame: Baseline, 3 weeks, 1-2-3-4 months]
  • Scale for the Assessment and Rating of Ataxia (SARA) [Time frame: Baseline, 3 weeks, 1-2-3-4 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Johns Hopkins Medical Institutions — Baltimore
  • Johns Hopkins Outpatient Center — Baltimore

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 26973594

Identifiers

NCT: NCT07253532 · IRB00530950

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗