Clinical trial NCT05115032: Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit
Official title: Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Equilibrium; Disorder, Labyrinth
Inner Ear Injury
Inner Ear Disease
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled interventional trial; single crossover; single-centre, open label
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: SOT composite score
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: Dizziness Handicap Inventory
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Secondary outcomes:
measure: ABC Score
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: FES-I score
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: SOT condition scores
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: LOS directional control
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: LOS excursion
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: DHI component scores
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
measure: SOT vestibular contribution
timeFrame: Through study completion, 12 rehabilitation sessions, an average of 7 weeks
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Dr. EA David MD FRCSC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Eytan A David, MD
role: PRINCIPAL_INVESTIGATOR
References: