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Completed

NCT Number: NCT04875013

Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

People that have difficulty with balance, such as those with damage to their inner ear, have a higher risk of falling, which may lead to anxiety and reduced quality of life. Some individuals that have lost part of their sense of balance can learn to compensate using information from their vision, their sense of where their limbs are in space, and from other balance organs that are still intact. Our study aims to determine if virtual reality used together with information from footplate sensors can be used to train people with balance problems to compensate for their inner ear deficits.

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Key information

Conditions

Dizziness Equilibrium; Disorder, Labyrinth Inner Ear Injury Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. EA David MD FRCSC

North Vancouver, British Columbia, V7M 2H5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult Age 18-80
  • Unilateral vestibular weakness confirmed one or more of:
  • Videonystagmography
  • VEMP
  • Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
  • Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
  • Symptomatic
  • Long-standing/persistent symptoms greater than one year

Exclusion criteria

  • Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
  • Neurological deficit or proprioception deficit
  • Diabetes
  • Poor vision or blindness
  • Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal deshicsence (SDCS)
  • Active benign paroxysmal positional vertigo (BPPV)
  • Undergoing treatment which may affect balance or ability to stand
  • Cognitive impairment that prevents understanding and responding to instructions required to complete the study
  • Inability to provide informed consent

Treatment and study plan

Vestibular rehabilitation with dynamic posturography

Device

Rehabilitation exercises guided by an interactive display and measured by a footplate sensor

Primary outcomes

  1. Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway

    Calculated as a composite of the 6 individual conditions of the SOT:

    • Eyes open on firm surface
    • Eyes closed on firm surface
    • Eyes open with sway referenced visual
    • Eyes open on sway referenced support surface
    • Eyes close on sway referenced support surfrace
    • Eyes open on sway referenced support surface and visual

  2. Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)

  3. Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)

  4. Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater perceived fall risk

  5. Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284.

    LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)

Secondary outcomes

  1. Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)

    The 6 conditions are:

    • Eyes open on firm surface
    • Eyes closed on firm surface
    • Eyes open with sway referenced visual
    • Eyes open on sway referenced support surface
    • Eyes close on sway referenced support surfrace
    • Eyes open on sway referenced support surface and visual

  2. Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit

  3. Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)

  4. Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)

    Time frame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks

    Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)

Other outcomes

  1. Adherence to Rehabilitation Protocol

    Time frame: Through study completion, maximum of 12 weeks

    Percentage of subjects that complete 12 sessions

  2. Missed Sessions

    Time frame: Through study completion, maximum of 12 weeks

    Mean number of missed and rescheduled rehabilitation sessions

Sponsors and collaborators

Lead sponsor

Eytan A. David

Other

Registry information

Official study title

Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 6, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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