Clinical trial NCT04875013: Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness
Official title: Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Equilibrium; Disorder, Labyrinth
Inner Ear Injury
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal cohort; single group assignment; interventional
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary outcomes:
measure: Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Other outcomes:
measure: Adherence to Rehabilitation Protocol
timeFrame: Through study completion, maximum of 12 weeks
measure: Missed Sessions
timeFrame: Through study completion, maximum of 12 weeks
Locations:
city: North Vancouver
country: Canada
facility: Dr. EA David MD FRCSC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Eytan David, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: David EA, Shahnaz N. Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):426-433. doi: 10.1001/jamaoto.2022.0167.