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Completed

NCT Number: NCT05115032

Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.

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Key information

Conditions

Dizziness Ear Diseases Equilibrium; Disorder, Labyrinth Inner Ear Disease Inner Ear Injury Labyrinth Diseases Neurologic Manifestations Otorhinolaryngologic Diseases 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

  • Dizziness handicap inventory score at time of enrolment over 30
  • Unilateral vestibular weakness confirmed one or more of:
  • Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%
  • VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP
  • VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear
  • 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 six months

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 dehiscence (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 retraining with dynamic posturography

Device

12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback

At-home rehabilitation exercises

Behavioral

6 weeks of daily rehabilitation exercises involving nodding and shaking of the head

Primary outcomes

  1. SOT composite score

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

    Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)

  2. Dizziness Handicap Inventory

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

    Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)

Secondary outcomes

  1. ABC Score

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

    Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)

  2. FES-I score

    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 impairment

  3. SOT condition scores

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

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

  4. LOS directional control

    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)

  5. LOS excursion

    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)

  6. DHI component scores

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

    Emotional, physical, and functional components of the DHI score

  7. SOT vestibular contribution

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

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

Sponsors and collaborators

Lead sponsor

Eytan A. David

Other

Registry information

Official study title

Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 10, 2021
Registry last updated
Apr 10, 2025

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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