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CompletedNCT05115032Updated Apr 10, 2025

Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

An interventional study of Vestibular retraining with dynamic posturography and At-home rehabilitation exercises in Dizziness, Equilibrium; Disorder, Labyrinth and Inner Ear Injury, sponsored by Eytan A. David. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Eytan A. David · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Dizziness
  • Equilibrium; Disorder, Labyrinth
  • Inner Ear Injury
  • Inner Ear Disease
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Vestibular retraining with dynamic posturography

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

    Device: Vestibular retraining with dynamic posturography

  • Active comparator
    At-home rehabilitation exercises

    Daily rehabilitation exercises involving nodding and shaking of the head

    Behavioral: At-home rehabilitation exercises

Interventions

  • DeviceVestibular retraining with dynamic posturography

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

  • BehavioralAt-home rehabilitation exercises

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

05

What researchers measure

Primary outcomes

  1. SOT composite score

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

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

  2. Dizziness Handicap Inventory

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

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

Secondary outcomes

  1. ABC Score

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

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

  2. FES-I score

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

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

  3. SOT condition scores

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

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

  4. LOS directional control

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

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

  5. LOS excursion

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

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

  6. DHI component scores

    Emotional, physical, and functional components of the DHI score

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

  7. SOT vestibular contribution

    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

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

06

Study locations

1 site
  • Dr. EA David MD FRCSC
    North Vancouver, British Columbia V7M 2H5, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05115032
Lead sponsor
Eytan A. David
Responsible party
Eytan A. David (MD, FRCSC, Clinical Instructor, Dept. of Surgery, University of British Columbia) — Sponsor-investigator
First posted
Nov 10, 2021
Start date
Jan 17, 2022
Primary completion
Dec 15, 2022
Completion
Apr 19, 2023
Last update
Apr 10, 2025

Study contacts

Eytan A David, MD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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