Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit

Not Applicable

Completed

• Conditions: Inner Ear Injury; Dizziness; Equilibrium; Disorder, Labyrinth; Inner Ear Disease

• Registration Number: NCT05115032
• Lead Sponsor: Eytan A. David

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Study Start: 2022-01-17
• Primary Completion: 2022-12-15
• Study Completion: 2023-04-19
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
SOT composite score	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)
Dizziness Handicap Inventory	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 Outcome Measures

Name	Time	Method
LOS excursion	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)
DHI component scores	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Emotional, physical, and functional components of the DHI score
FES-I score	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
SOT condition scores	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)
SOT vestibular contribution	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
ABC Score	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)
LOS directional control	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)

Trial Locations

Locations (1)

Dr. EA David MD FRCSC; 🇨🇦 North Vancouver, British Columbia, Canada