Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

Efficacy of Vestibular Rehabilitation Using Computerized Dynamic Posturography With Virtual Reality for Stable Unilateral Vestibular Weakness

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04875013

Enrollment

Registered

2021-05-06

Start date

2021-05-10

Completion date

2021-10-31

Last updated

2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dizziness, Equilibrium; Disorder, Labyrinth, Inner Ear Injury

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.

Interventions

DEVICEVestibular rehabilitation with dynamic posturography

Rehabilitation exercises guided by an interactive display and measured by a footplate sensor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Longitudinal cohort; single group assignment; interventional

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Fall Efficacy Scale-International (FES-I) (Score After Retraining Minus Score at Baseline)	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 perceived fall risk
Change in Sensory Organization Test (SOT) Composite Score (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in composite score of Sensory Organization Test (SOT) (Scores from 0-100; higher scores indicate better function); Lower scores indicate larger amount of sway Calculated as a composite of the 6 individual conditions of the SOT: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
Change in Dizziness Handicap Inventory Score (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in Dizziness Handicap Inventory (DHI); scale from 0-100; higher scores indicate greater disability; 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap)
Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)
Change in Limits of Stability Area (Area After Retraining Minus Area at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in endpoint excursion and maximum excursion functional stability region area, calculated from Limits of Stability (LOS) score Higher score indicates an ability to volitionally lean to larger angles. 100% of theoretical maximum in all directions would give an area of 28284. LOS excursion scores were calculated by the instrument software, from which we calculated the area of the endpoint excursion functional stability region (the sum of areas between adjacent Endpoint Excursion limits) and the area of the maximum excursion functional stability region (the sum of areas between adjacent Maximum Excursion limits) using published methods (Alvarez-Otero R, Perez-Fernandez N. The limits of stability in patients with unilateral vestibulopathy. Acta Oto-laryngol. 2017;137(10):1-6. doi:10.1080/00016489.2017.1339326)

Secondary

Measure	Time frame	Description
Change in Sensory Organization Test Scores for Conditions 1 to 6 (Scores After Retraining Minus Scores at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in mean Sensory Organization Test Scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function) The 6 conditions are: 1. Eyes open on firm surface 2. Eyes closed on firm surface 3. Eyes open with sway referenced visual 4. Eyes open on sway referenced support surface 5. Eyes close on sway referenced support surfrace 6. Eyes open on sway referenced support surface and visual
Change in Sensory Organization Test Vestibular Contribution (Ratio After Retraining Minus Ratio at Baseline)	Through study completion, 12 rehabilitation sessions, an average of 7 weeks	Change in mean value of Sensory Organization Test condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit
Change in Limits of Stability Directional Control Component (Score After Retraining Minus Score at Baseline)	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)
Change in Endpoint and Maximum Excursion Values From Limits of Stability Test (Score After Retraining Minus Score at Baseline)	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)

Other

Measure	Time frame	Description
Missed Sessions	Through study completion, maximum of 12 weeks	Mean number of missed and rescheduled rehabilitation sessions
Adherence to Rehabilitation Protocol	Through study completion, maximum of 12 weeks	Percentage of subjects that complete 12 sessions

Countries

Canada

Participant flow

Participants by arm

Arm	Count
Vestibular Rehabilitation With Dynamic Posturography 12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback Vestibular rehabilitation with dynamic posturography: Rehabilitation exercises guided by an interactive display and measured by a footplate sensor	13
Total	13

Baseline characteristics

Characteristic	Vestibular Rehabilitation With Dynamic Posturography	—
Age, Continuous	51 years	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	5 Participants	—
Sex: Female, Male Male	8 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 13
other Total, other adverse events	0 / 13
serious Total, serious adverse events	0 / 13

Outcome results

Primary

Change in Activities-specific Balance Confidence Scale Score (Score After Retraining Minus Score at Baseline)

Change in Activities-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate greater confidence in performing activities of daily living)